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The Safety and Efficacy of MoodElite T-4003-1 on Improving Mood in a Healthy Adult Population With Mild to Moderate Depressive Symptoms Not Eligible for Therapeutic Intervention

Primary Purpose

Mood

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
MoodElite T-4003-1
Comparator
Placebo
Sponsored by
Chenland Nutritionals Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mood focused on measuring Mild to moderate depression, Mild to moderate depressive symptoms not eligible for therapeutic intervention, MoodElite T-4003-1

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Individuals 18-65 years of age, inclusive

  2. Individual is not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least one year prior to screening

    Or,

    Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:

    • Injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
    • Double-barrier method
    • Intrauterine devices
    • Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
    • Vasectomy of partner at least 6 months prior to screening
  3. Individuals with mild to mild-moderate depressive symptoms, as determined by a score of 14-24 on the BDI-II at screening, and as assessed by the Qualified Investigator (QI)
  4. Education level no less than that of primary school
  5. Individuals who can read and write in English and can understand the BDI-II
  6. Agrees to maintain current lifestyle habits as much as possible throughout the study depending on your ability to maintain the following: diet, medications, supplements, exercise, and sleep and avoid taking new supplements during the study period
  7. Provided voluntary, written, informed consent to participate in the study
  8. Healthy as determined by medical history and laboratory results as assessed by QI

Exclusion Criteria:

  1. Women who are pregnant, breast feeding, or planning to become pregnant during the study
  2. Allergy, sensitivity, or intolerance to the investigational product's active or inactive ingredients
  3. History of diagnosed chronic or major depression as assessed by the QI
  4. Participants undergoing behavioural therapy for depression. Participants who have completed at least 8 sessions of behavioural therapy with no improvement will be considered by the QI
  5. Suicidal ideation as assessed by the BDI-II
  6. History of psychiatric disorders such as organic brain disorders, bipolar affective disorder, personality disorder, as assessed by the QI
  7. Diagnosed insomnia or other sleep disorders as assessed by the QI
  8. Current employment that calls for shift work or have worked shift work in the last 3 weeks
  9. Travel across 1 or more-time zones in the last 2 weeks and/or is anticipating more travel
  10. Current use of prescribed medications, over-the-counter (OTC) medications, or supplements taken for treatment of depression or used to help sleep
  11. Current use of prescribed medications that interact with Hypericum perforatum
  12. Unstable metabolic disease or chronic diseases as assessed by the QI
  13. Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
  14. Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI
  15. Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
  16. Individuals with an autoimmune disease or are immune compromised as assessed by the QI
  17. Use of medical cannabinoid products
  18. Current chronic use of cannabinoid products (>8 times/month) and is unwilling to stop for the duration of the study beginning 1 week prior to baseline. History of chronic and occasional use and the purpose of use to be assessed by QI on a case-by-case basis
  19. Alcohol intake >2 standard drinks per day as assessed by the QI
  20. Alcohol or drug abuse within the last 12 months
  21. Clinically significant abnormal laboratory results at screening as assessed by the QI
  22. Participation in other clinical research studies 30 days prior to enrollment will be assessed on a case-by-case basis by the QI
  23. Individuals who are unable to give informed consent
  24. Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant

Sites / Locations

  • KGK Science Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

MoodElite T-4003-1

Comparator

Placebo

Arm Description

Participants will be instructed to take two capsules of MoodElite T-4003-1 once daily with water, after dinner without food starting on Day 0 for 42 days. If a dose is missed participants are instructed to take the dose as soon as they remember. Participants will be advised not to exceed 4 capsules daily.

Participants will be instructed to take two capsules of comparator once daily with water, after dinner without food starting on Day 0 for 42 days. If a dose is missed participants are instructed to take the dose as soon as they remember. Participants will be advised not to exceed 4 capsules daily.

Participants will be instructed to take two capsules of placebo once daily with water, after dinner without food starting on Day 0 for 42 days. If a dose is missed participants are instructed to take the dose as soon as they remember. Participants will be advised not to exceed 4 capsules daily.

Outcomes

Primary Outcome Measures

Change in mood between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by BDI-ll
The change in mood between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using Beck Depression Inventory-II (BDI-II). The BDI-II contains 21 items on a 4-point scale from 0 'Symptom Absent' to 3 'Severe Symptom'. Scoring is achieved by adding the highest ratings for all 21 items with a minimum score of 0 and maximum score of 63. A higher total BDI-II score indicates greater symptom severity.
Change in total mood disturbance between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by POMS Questionnaire
The change in total mood disturbance between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using Profile of Mood States (POMS) Questionnaire. The POMS questionnaire is used to measure mood states, with its validity well established as its methodology has been used in many clinical trials. POMS are a self-reported assessment of mood that is adaptable to capturing transient and fluctuating feelings, or relatively enduring affect states and contributes to a comprehensive assessment by providing indications of potential mood disturbance. Each item contains a 5-point Likert scale characterizing the possible strengths of a specific feeling (e.g. friendly, sad, helpful) ranging from 'Not at all' to 'Extremely'.

Secondary Outcome Measures

Change in tension-anxiety between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by POMS
The change in POMS subscale of tension-anxiety between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using Profile of Mood States (POMS) Questionnaire. The POMS questionnaire is used to measure mood states, with its validity well established as its methodology has been used in many clinical trials. POMS are a self-reported assessment of mood that is adaptable to capturing transient and fluctuating feelings, or relatively enduring affect states and contributes to a comprehensive assessment by providing indications of potential mood disturbance. Each item contains a 5-point Likert scale characterizing the possible strengths of a specific feeling (e.g. friendly, sad, helpful) ranging from 'Not at all' to 'Extremely'.
Change in depression between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by POMS
The change in POMS subscale of depression between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using Profile of Mood States (POMS) Questionnaire. The POMS questionnaire is used to measure mood states, with its validity well established as its methodology has been used in many clinical trials. POMS are a self-reported assessment of mood that is adaptable to capturing transient and fluctuating feelings, or relatively enduring affect states and contributes to a comprehensive assessment by providing indications of potential mood disturbance. Each item contains a 5-point Likert scale characterizing the possible strengths of a specific feeling (e.g. friendly, sad, helpful) ranging from 'Not at all' to 'Extremely'.
Change in anger-hostility between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by POMS
The change in POMS subscale of anger-hostility between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using Profile of Mood States (POMS) Questionnaire. The POMS questionnaire is used to measure mood states, with its validity well established as its methodology has been used in many clinical trials. POMS are a self-reported assessment of mood that is adaptable to capturing transient and fluctuating feelings, or relatively enduring affect states and contributes to a comprehensive assessment by providing indications of potential mood disturbance. Each item contains a 5-point Likert scale characterizing the possible strengths of a specific feeling (e.g. friendly, sad, helpful) ranging from 'Not at all' to 'Extremely'.
Change in vigor between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by POMS
The change in POMS subscale of vigor between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using Profile of Mood States (POMS) Questionnaire. The POMS questionnaire is used to measure mood states, with its validity well established as its methodology has been used in many clinical trials. POMS are a self-reported assessment of mood that is adaptable to capturing transient and fluctuating feelings, or relatively enduring affect states and contributes to a comprehensive assessment by providing indications of potential mood disturbance. Each item contains a 5-point Likert scale characterizing the possible strengths of a specific feeling (e.g. friendly, sad, helpful) ranging from 'Not at all' to 'Extremely'.
Change in fatigue between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by POMS
The change in POMS subscale of fatigue between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using Profile of Mood States (POMS) Questionnaire. The POMS questionnaire is used to measure mood states, with its validity well established as its methodology has been used in many clinical trials. POMS are a self-reported assessment of mood that is adaptable to capturing transient and fluctuating feelings, or relatively enduring affect states and contributes to a comprehensive assessment by providing indications of potential mood disturbance. Each item contains a 5-point Likert scale characterizing the possible strengths of a specific feeling (e.g. friendly, sad, helpful) ranging from 'Not at all' to 'Extremely'.
Change in confusion between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by POMS
The change in POMS subscale of confusion between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using Profile of Mood States (POMS) Questionnaire. The POMS questionnaire is used to measure mood states, with its validity well established as its methodology has been used in many clinical trials. POMS are a self-reported assessment of mood that is adaptable to capturing transient and fluctuating feelings, or relatively enduring affect states and contributes to a comprehensive assessment by providing indications of potential mood disturbance. Each item contains a 5-point Likert scale characterizing the possible strengths of a specific feeling (e.g. friendly, sad, helpful) ranging from 'Not at all' to 'Extremely'.
Change in subjective sleep efficiency between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by the Sleep Quality Questionnaire
The change in subjective sleep efficiency between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using the Sleep Quality Questionnaire. Participants will be asked a total of 18 questions. Four will capture information regarding a typical 7-day period consisting of 5 weekdays and 2 weekend days. The remaining 14 questions use a 5-point Likert scale ranging from 'Strongly Disagree' to 'Strongly Agree'.
Change in perceived sleep debt between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by the Sleep Quality Questionnaire
The change in perceived sleep debt between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using the Sleep Quality Questionnaire. Participants will be asked a total of 18 questions. Four will capture information regarding a typical 7-day period consisting of 5 weekdays and 2 weekend days. The remaining 14 questions use a 5-point Likert scale ranging from 'Strongly Disagree' to 'Strongly Agree'.
Change in perceived sleep difficulty between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by the Sleep Quality Questionnaire.
The change in perceived sleep difficulty between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using the Sleep Quality Questionnaire. Participants will be asked a total of 18 questions. Four will capture information regarding a typical 7-day period consisting of 5 weekdays and 2 weekend days. The remaining 14 questions use a 5-point Likert scale ranging from 'Strongly Disagree' to 'Strongly Agree'.
Change in objective sleep measures between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by actigraphy readings
The change in objective sleep measures between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using actigraphy readings. The actigraphy device is an objective measure of sleep during the study period. Each subject will wear the actigraphy device on their non-dominant arm for seven consecutive days prior to each study visit, allowing for charging and periods when the device is may not be worn (i.e. showering). The actigraphy device will be used to collect sleep outcome variables including but not limited to sleep start and end, average length and number of awakenings, sleep efficiency, sleep latency, time asleep, wake episodes, and fragmentation index.
Change in vitality throughout the day between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by Vitality and Quality of Life Questionnaire
The change in vitality throughout the day between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using the Vitality and Quality of Life Questionnaire. The Vitality and QoL Questionnaire will be used to assess the energy levels and quality of life of the participants. The 31-item questionnaire consists of a 7-point Likert scale, with answers ranging from 1 to 7. The higher the summative score the more vitality that was subjectively perceived by the participants.
Change in blood melatonin levels between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation
The change in blood melatonin levels between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be measured.
Change in fecal microbiome between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation
The change in fecal microbiome between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be measured.

Full Information

First Posted
April 1, 2022
Last Updated
March 21, 2023
Sponsor
Chenland Nutritionals Inc.
Collaborators
KGK Science Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05318456
Brief Title
The Safety and Efficacy of MoodElite T-4003-1 on Improving Mood in a Healthy Adult Population With Mild to Moderate Depressive Symptoms Not Eligible for Therapeutic Intervention
Official Title
A Randomized, Triple-blind, Placebo-controlled, Parallel Clinical Trial to Investigate the Safety and Efficacy of MoodElite T-4003-1 on Improving Mood in a Healthy Adult Population With Mild to Moderate Depressive Symptoms Not Eligible for Therapeutic Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
March 24, 2022 (Actual)
Primary Completion Date
January 19, 2023 (Actual)
Study Completion Date
March 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chenland Nutritionals Inc.
Collaborators
KGK Science Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to investigate the efficacy and safety of MoodElite T-4003-1 on improving mood in a healthy adult population with mild to moderate depressive symptoms not eligible for therapeutic intervention.
Detailed Description
The objective of this study is to investigate the safety and efficacy of 42-day supplementation of MoodElite T-4003-1 on improving mood in healthy adults. The efficacy of MoodElite T-4003-1 on mood will be assessed by the Beck Depression Inventory (BDI-II) and Profile of Mood States (POMS) Questionnaire. POMS is a self-reported assessment of mood that is adaptable to capturing transient and fluctuating feelings, or relatively enduring affect states and contributes to a comprehensive assessment by providing indications of potential mood disturbance. Self-reported sleep efficiency, perceived sleep debt, and sleep difficulty will be assessed by a Sleep Quality Questionnaire and supported by sleep scoring from actigraphy readings. As vitality is related to both mood and sleep, the Vitality and Quality of Life questionnaire will be used to measure changes in energy levels and quality of life over the 42-day study period. The effects of MoodElite T-4003-1 will be compared to a placebo and comparator product, EasyMind T-4008-1. EasyMind T-4008-1 contains extracts from Paeonia lactiflora, Gardenia jasminoides, Albizia julibrissin, Paeonia suffruticosa and has been shown to reduce anxiety-like behaviour in a rodent model using chronic restraint stress through reduction of corticosterone (cortisol) (unpublished results). For the study population, the eligibility criteria limits the presence of confounding variables that could influence study outcomes. Participants will be healthy men and women between 18 and 65 years of age. Individuals will be recruited based on having mild to moderate depressive symptoms, as assessed by the BDI-II. The BDI-II contains 21 items and evaluates both psychological and physical symptoms related to depression. Participants with diagnosed chronic or major depression or psychiatric disorders will be excluded to ensure only those with mild, non-pathological depressive symptoms are enrolled. Any participants taking prescribed or over the counter mood altering medications will be excluded, as not to interfere with the evaluation of the effects of MoodElite T-4003-1 on mood. Participants taking supplements for mood support at a stable dose for at least three months will be evaluated by the QI to determine eligibility. Shift workers or individuals who have recently travelled across one or more time zones will be excluded to limit any confounding effects on outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mood
Keywords
Mild to moderate depression, Mild to moderate depressive symptoms not eligible for therapeutic intervention, MoodElite T-4003-1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MoodElite T-4003-1
Arm Type
Experimental
Arm Description
Participants will be instructed to take two capsules of MoodElite T-4003-1 once daily with water, after dinner without food starting on Day 0 for 42 days. If a dose is missed participants are instructed to take the dose as soon as they remember. Participants will be advised not to exceed 4 capsules daily.
Arm Title
Comparator
Arm Type
Active Comparator
Arm Description
Participants will be instructed to take two capsules of comparator once daily with water, after dinner without food starting on Day 0 for 42 days. If a dose is missed participants are instructed to take the dose as soon as they remember. Participants will be advised not to exceed 4 capsules daily.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will be instructed to take two capsules of placebo once daily with water, after dinner without food starting on Day 0 for 42 days. If a dose is missed participants are instructed to take the dose as soon as they remember. Participants will be advised not to exceed 4 capsules daily.
Intervention Type
Dietary Supplement
Intervention Name(s)
MoodElite T-4003-1
Intervention Description
Participants will be instructed to take two capsules of MoodElite T-4003-1 once daily with water, after dinner without food for 42 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
Comparator
Intervention Description
Participants will be instructed to take two capsules of comparator once daily with water, after dinner without food for 42 days.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Participants will be instructed to take two capsules of placebo once daily with water, after dinner without food for 42 days.
Primary Outcome Measure Information:
Title
Change in mood between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by BDI-ll
Description
The change in mood between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using Beck Depression Inventory-II (BDI-II). The BDI-II contains 21 items on a 4-point scale from 0 'Symptom Absent' to 3 'Severe Symptom'. Scoring is achieved by adding the highest ratings for all 21 items with a minimum score of 0 and maximum score of 63. A higher total BDI-II score indicates greater symptom severity.
Time Frame
Days 0, 42 and day 56 (follow-up)
Title
Change in total mood disturbance between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by POMS Questionnaire
Description
The change in total mood disturbance between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using Profile of Mood States (POMS) Questionnaire. The POMS questionnaire is used to measure mood states, with its validity well established as its methodology has been used in many clinical trials. POMS are a self-reported assessment of mood that is adaptable to capturing transient and fluctuating feelings, or relatively enduring affect states and contributes to a comprehensive assessment by providing indications of potential mood disturbance. Each item contains a 5-point Likert scale characterizing the possible strengths of a specific feeling (e.g. friendly, sad, helpful) ranging from 'Not at all' to 'Extremely'.
Time Frame
Days 0, 42 and day 56 (follow-up)
Secondary Outcome Measure Information:
Title
Change in tension-anxiety between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by POMS
Description
The change in POMS subscale of tension-anxiety between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using Profile of Mood States (POMS) Questionnaire. The POMS questionnaire is used to measure mood states, with its validity well established as its methodology has been used in many clinical trials. POMS are a self-reported assessment of mood that is adaptable to capturing transient and fluctuating feelings, or relatively enduring affect states and contributes to a comprehensive assessment by providing indications of potential mood disturbance. Each item contains a 5-point Likert scale characterizing the possible strengths of a specific feeling (e.g. friendly, sad, helpful) ranging from 'Not at all' to 'Extremely'.
Time Frame
Days 0, 42 and day 56 (follow-up)
Title
Change in depression between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by POMS
Description
The change in POMS subscale of depression between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using Profile of Mood States (POMS) Questionnaire. The POMS questionnaire is used to measure mood states, with its validity well established as its methodology has been used in many clinical trials. POMS are a self-reported assessment of mood that is adaptable to capturing transient and fluctuating feelings, or relatively enduring affect states and contributes to a comprehensive assessment by providing indications of potential mood disturbance. Each item contains a 5-point Likert scale characterizing the possible strengths of a specific feeling (e.g. friendly, sad, helpful) ranging from 'Not at all' to 'Extremely'.
Time Frame
Days 0, 42 and day 56 (follow-up)
Title
Change in anger-hostility between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by POMS
Description
The change in POMS subscale of anger-hostility between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using Profile of Mood States (POMS) Questionnaire. The POMS questionnaire is used to measure mood states, with its validity well established as its methodology has been used in many clinical trials. POMS are a self-reported assessment of mood that is adaptable to capturing transient and fluctuating feelings, or relatively enduring affect states and contributes to a comprehensive assessment by providing indications of potential mood disturbance. Each item contains a 5-point Likert scale characterizing the possible strengths of a specific feeling (e.g. friendly, sad, helpful) ranging from 'Not at all' to 'Extremely'.
Time Frame
Days 0, 42 and day 56 (follow-up)
Title
Change in vigor between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by POMS
Description
The change in POMS subscale of vigor between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using Profile of Mood States (POMS) Questionnaire. The POMS questionnaire is used to measure mood states, with its validity well established as its methodology has been used in many clinical trials. POMS are a self-reported assessment of mood that is adaptable to capturing transient and fluctuating feelings, or relatively enduring affect states and contributes to a comprehensive assessment by providing indications of potential mood disturbance. Each item contains a 5-point Likert scale characterizing the possible strengths of a specific feeling (e.g. friendly, sad, helpful) ranging from 'Not at all' to 'Extremely'.
Time Frame
Days 0, 42 and day 56 (follow-up)
Title
Change in fatigue between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by POMS
Description
The change in POMS subscale of fatigue between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using Profile of Mood States (POMS) Questionnaire. The POMS questionnaire is used to measure mood states, with its validity well established as its methodology has been used in many clinical trials. POMS are a self-reported assessment of mood that is adaptable to capturing transient and fluctuating feelings, or relatively enduring affect states and contributes to a comprehensive assessment by providing indications of potential mood disturbance. Each item contains a 5-point Likert scale characterizing the possible strengths of a specific feeling (e.g. friendly, sad, helpful) ranging from 'Not at all' to 'Extremely'.
Time Frame
Days 0, 42 and day 56 (follow-up)
Title
Change in confusion between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by POMS
Description
The change in POMS subscale of confusion between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using Profile of Mood States (POMS) Questionnaire. The POMS questionnaire is used to measure mood states, with its validity well established as its methodology has been used in many clinical trials. POMS are a self-reported assessment of mood that is adaptable to capturing transient and fluctuating feelings, or relatively enduring affect states and contributes to a comprehensive assessment by providing indications of potential mood disturbance. Each item contains a 5-point Likert scale characterizing the possible strengths of a specific feeling (e.g. friendly, sad, helpful) ranging from 'Not at all' to 'Extremely'.
Time Frame
Days 0, 42 and day 56 (follow-up)
Title
Change in subjective sleep efficiency between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by the Sleep Quality Questionnaire
Description
The change in subjective sleep efficiency between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using the Sleep Quality Questionnaire. Participants will be asked a total of 18 questions. Four will capture information regarding a typical 7-day period consisting of 5 weekdays and 2 weekend days. The remaining 14 questions use a 5-point Likert scale ranging from 'Strongly Disagree' to 'Strongly Agree'.
Time Frame
Days 0 and 42
Title
Change in perceived sleep debt between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by the Sleep Quality Questionnaire
Description
The change in perceived sleep debt between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using the Sleep Quality Questionnaire. Participants will be asked a total of 18 questions. Four will capture information regarding a typical 7-day period consisting of 5 weekdays and 2 weekend days. The remaining 14 questions use a 5-point Likert scale ranging from 'Strongly Disagree' to 'Strongly Agree'.
Time Frame
Days 0 and 42
Title
Change in perceived sleep difficulty between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by the Sleep Quality Questionnaire.
Description
The change in perceived sleep difficulty between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using the Sleep Quality Questionnaire. Participants will be asked a total of 18 questions. Four will capture information regarding a typical 7-day period consisting of 5 weekdays and 2 weekend days. The remaining 14 questions use a 5-point Likert scale ranging from 'Strongly Disagree' to 'Strongly Agree'.
Time Frame
Days 0 and 42
Title
Change in objective sleep measures between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by actigraphy readings
Description
The change in objective sleep measures between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using actigraphy readings. The actigraphy device is an objective measure of sleep during the study period. Each subject will wear the actigraphy device on their non-dominant arm for seven consecutive days prior to each study visit, allowing for charging and periods when the device is may not be worn (i.e. showering). The actigraphy device will be used to collect sleep outcome variables including but not limited to sleep start and end, average length and number of awakenings, sleep efficiency, sleep latency, time asleep, wake episodes, and fragmentation index.
Time Frame
Days 0 and 42
Title
Change in vitality throughout the day between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation as assessed by Vitality and Quality of Life Questionnaire
Description
The change in vitality throughout the day between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be assessed using the Vitality and Quality of Life Questionnaire. The Vitality and QoL Questionnaire will be used to assess the energy levels and quality of life of the participants. The 31-item questionnaire consists of a 7-point Likert scale, with answers ranging from 1 to 7. The higher the summative score the more vitality that was subjectively perceived by the participants.
Time Frame
Days 0 and 42
Title
Change in blood melatonin levels between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation
Description
The change in blood melatonin levels between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be measured.
Time Frame
Days 0 and 42
Title
Change in fecal microbiome between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation
Description
The change in fecal microbiome between MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo from baseline to day 42 after supplementation will be measured.
Time Frame
Days 0 and 42
Other Pre-specified Outcome Measures:
Title
Incidence of pre-emergent adverse events following 42 days of supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo
Description
Incidence of pre-emergent adverse events following 42 days of supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.
Time Frame
Days 0 and 42
Title
Incidence of post-emergent adverse events following 42 days of supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo
Description
Incidence of post-emergent adverse events following 42 days of supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.
Time Frame
Days 0 and 42
Title
Change in Aspartate Aminotransferase levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo
Description
Change in Aspartate Aminotransferase levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo will be determined.
Time Frame
Days 0 and 42
Title
Change in alanine aminotransferase levels from baseline to baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo
Description
Change in alanine aminotransferase levels from baseline to baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), and placebo will be determined.
Time Frame
Days 0 and 42
Title
Change in urinalysis levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo
Description
Change in urinalysis levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.
Time Frame
Days 0 and 42
Title
Change in alkaline phosphatase levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo
Description
Change in alkaline phosphatase levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.
Time Frame
Days 0 and 42
Title
Change in total bilirubin levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo
Description
Change in total bilirubin levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.
Time Frame
Days 0 and 42
Title
Change in creatinine levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo
Description
Change in creatinine levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.
Time Frame
Days 0 and 42
Title
Change in potassium levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo
Description
Change in potassium levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.
Time Frame
Days 0 and 42
Title
Change in sodium levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo
Description
Change in sodium levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.
Time Frame
Days 0 and 42
Title
Change in chloride levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo
Description
Change in chloride levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.
Time Frame
Days 0 and 42
Title
Change in glucose levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo
Description
Change in glucose levels from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.
Time Frame
Days 0 and 42
Title
Change in estimated glomerular filtration rate (eGFR) from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo
Description
Change in estimated glomerular filtration rate (eGFR) from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.
Time Frame
Days 0 and 42
Title
Change in white blood cell count from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo
Description
Change in white blood cell count from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.
Time Frame
Days 0 and 42
Title
Change in levels of neutrophils from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo
Description
Change in levels of neutrophils from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.
Time Frame
Days 0 and 42
Title
Change in levels of lymphocytes from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo
Description
Change in levels of lymphocytes from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.
Time Frame
Days 0 and 42
Title
Change in levels of monocytes from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo
Description
Change in levels of monocytes from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.
Time Frame
Days 0 and 42
Title
Change in levels of eosinophils from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo
Description
Change in levels of eosinophils from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.
Time Frame
Days 0 and 42
Title
Change in levels of basophils from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo
Description
Change in levels of basophils from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.
Time Frame
Days 0 and 42
Title
Change in levels of hemoglobin from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo
Description
Change in levels of hemoglobin from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.
Time Frame
Days 0 and 42
Title
Change in levels of hematocrit from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo
Description
Change in levels of hematocrit from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.
Time Frame
Days 0 and 42
Title
Change in Red Blood Cell Count from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo
Description
Change in Red Blood Cell Count from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.
Time Frame
Days 0 and 42
Title
Change in platelet count from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo
Description
Change in platelet count from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.
Time Frame
Days 0 and 42
Title
Change in levels of immature granulocytes from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo
Description
Change in levels of immature granulocytes from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.
Time Frame
Days 0 and 42
Title
Change in levels of nucleated red blood cells from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo
Description
Change in levels of nucleated red blood cells from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.
Time Frame
Days 0 and 42
Title
Change in mean corpuscular volume from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo
Description
Change in mean corpuscular volume from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.
Time Frame
Days 0 and 42
Title
Change in mean corpuscular hemoglobin from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo
Description
Change in mean corpuscular hemoglobin from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.
Time Frame
Days 0 and 42
Title
Change in mean corpuscular hemoglobin concentration from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo
Description
Change in mean corpuscular hemoglobin concentration from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.
Time Frame
Days 0 and 42
Title
Change in red cell distribution width from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo
Description
Change in red cell distribution width from baseline to 42 days following supplementation with MoodElite T-4003-1, comparator (EasyMind T-4008-1), or placebo will be determined.
Time Frame
Days 0 and 42

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Individuals 18-65 years of age, inclusive Individual is not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least one year prior to screening Or, Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include: Injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System) Double-barrier method Intrauterine devices Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s) Vasectomy of partner at least 6 months prior to screening Individuals with mild to mild-moderate depressive symptoms, as determined by a score of 14-24 on the BDI-II at screening, and as assessed by the Qualified Investigator (QI) Education level no less than that of primary school Individuals who can read and write in English and can understand the BDI-II Agrees to maintain current lifestyle habits as much as possible throughout the study depending on your ability to maintain the following: diet, medications, supplements, exercise, and sleep and avoid taking new supplements during the study period Provided voluntary, written, informed consent to participate in the study Healthy as determined by medical history and laboratory results as assessed by QI Exclusion Criteria: Women who are pregnant, breast feeding, or planning to become pregnant during the study Allergy, sensitivity, or intolerance to the investigational product's active or inactive ingredients History of diagnosed chronic or major depression as assessed by the QI Participants undergoing behavioural therapy for depression. Participants who have completed at least 8 sessions of behavioural therapy with no improvement will be considered by the QI Suicidal ideation as assessed by the BDI-II History of psychiatric disorders such as organic brain disorders, bipolar affective disorder, personality disorder, as assessed by the QI Diagnosed insomnia or other sleep disorders as assessed by the QI Current employment that calls for shift work or have worked shift work in the last 3 weeks Travel across 1 or more-time zones in the last 2 weeks and/or is anticipating more travel Current use of prescribed medications, over-the-counter (OTC) medications, or supplements taken for treatment of depression or used to help sleep Current use of prescribed medications that interact with Hypericum perforatum Unstable metabolic disease or chronic diseases as assessed by the QI Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable Individuals with an autoimmune disease or are immune compromised as assessed by the QI Use of medical cannabinoid products Current chronic use of cannabinoid products (>8 times/month) and is unwilling to stop for the duration of the study beginning 1 week prior to baseline. History of chronic and occasional use and the purpose of use to be assessed by QI on a case-by-case basis Alcohol intake >2 standard drinks per day as assessed by the QI Alcohol or drug abuse within the last 12 months Clinically significant abnormal laboratory results at screening as assessed by the QI Participation in other clinical research studies 30 days prior to enrollment will be assessed on a case-by-case basis by the QI Individuals who are unable to give informed consent Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Crowley, MD
Organizational Affiliation
KGK Science Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
KGK Science Inc.
City
London
State/Province
Ontario
ZIP/Postal Code
N6A5R8
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

The Safety and Efficacy of MoodElite T-4003-1 on Improving Mood in a Healthy Adult Population With Mild to Moderate Depressive Symptoms Not Eligible for Therapeutic Intervention

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