search
Back to results

ACUTE AND CHRONIC EFFECTS OF A BOTANICAL EXTRACT ON ANXIETY, PERCEIVED STRESS, MOOD AND CORTISOL IN HEALTHY ADULTS

Primary Purpose

Mood Disorders

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Proprietary, standardized botanical extract
Placebo (maltodextrin)
Sponsored by
Activ'inside
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mood Disorders focused on measuring Mood, Anxiety, Stress, Dietary supplement, Botanical

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • With non-pathological feelings of anxiety and/ or stress in daily life:

    • Subjects self-reporting low mood;
    • Total score ≥ 40 at the Profile of Mood State (POMS 2);
    • Score < 16 at the Generalized Anxiety Disorder 7-item (GAD-7) questionnaire
    • Score ≤ 10 at the Patient Health Questionnaire 9-item (PHQ-9)
    • Not meeting the diagnosis criteria for any mental disorder
  • Body Mass Index (BMI) in the normal range: 18.5 ≥ BMI ≤ 30 kg/ m2
  • For non-menopausal women: using effective contraception/pregnancy is not physiologically possible.
  • Subject showing no difficulty for salivary sampling
  • Subjects capable of and willing to comply with the protocol and to give their written informed consent

Main Exclusion Criteria:

  • Diagnosis of psychological pathology within the previous 3 years
  • Diagnosis of cognitive pathology
  • Anxiolytic or antidepressant treatment, within the previous 3 months
  • Event likely to have impacted the subject's emotional and/ or psychological state within the last 8 weeks or planned during the next 8 weeks
  • Menopausal transition
  • High blood pressure
  • Subjects diagnosed with diabetes, cardiovascular disease, recurrent infectious diseases or chronic inflammatory pathology
  • Usual corticoid treatment/ steroidal anti-inflammatory treatment
  • Unbalanced thyroid disease
  • High physical activity practice
  • Tobacco consumption
  • Subjects consuming any food supplement
  • Excessive alcohol or caffeine use
  • Consumption of recreational drugs
  • Subject currently participating in other clinical or nutrition intervention studies, or has done in the past 4 weeks.

Sites / Locations

  • Brain, Performance and Nutrition Research Centre, Northumbria University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active group

Placebo group

Arm Description

Proprietary, standardized botanical extract

Placebo (maltodextrin)

Outcomes

Primary Outcome Measures

Mood state
Variation of the Profile of mood states (POMS-2) total score: TMD (Total Mood Disturbance score). The POMS-2 is a scale which includes six mood subscales: Anger, Confusion, Depression, Fatigue, Tension, and Vigor. Each subscale is scored between 0 and 100. TMD is determined by summing the Negative Mood State subscores and subtracting the Vigor subscore (unique Positive Mood State subscale). For each subscale except Vigor, a lower subscore indicates a better mood state. For the Vigor subscale, a higher subscore indicates a better mood state. A lower POMS-2 TMD indicates a better mood state.

Secondary Outcome Measures

POMS-2 subscores
Variation of the POMS-2 subscores: Anger, Confusion, Depression, Fatigue, Tension, and Vigor. Each subscale is scored between 0 and 100. For each subscale except Vigor, a lower subscore indicates a better mood state. For the Vigor subscale, a higher subscore indicates a better mood state.
Anxiety state State-Trait Anxiety Inventory
Variation of the State-Trait Anxiety Inventory (STAI-State) score. Min score: 20; Max score: 80. Higher score corresponds to a higher level of anxiety.
Anxiety state according to the Hospital Anxiety and Depression Scale
Variation of the anxiety subscore of the Hospital Anxiety and Depression Scale (HADS-A). Min score: 0; Max score: 21. Higher score corresponds to a higher level of anxiety.
Percentage of responders
A responder is defined as a participant with a statistically significant reduction of the POMS-2 TMD T-score. A lower POMS-2 TMD indicates a better mood state.
Psychological stress
Variation of the Perceived Stress Scale (PSS-10) score (min score: 0; max score: 40; a higher score corresponds to a lower psychological stress feeling)
Worry feeling
Variation of the Penn State Worry Questionnaire score (min score: 16; max score: 80; a higher score corresponds to a higher worry feeling)
Coping response to stress
Variations of the COPE inventory score (min score: 60; max score: 240). A higher score indicates that the subject uses more coping strategies in response to stress.
Depressive-like state
Variation of the depression subscore of the HADS (HADS-D). HADS-D score is comprised between 0 and 21. A higher HADS-D score indicates a higher level of depression.
Quality of life score
Variation of the World Health Organisation Quality of Life questionnaire (WHOQOL-BREF) score, comprised between 16 and 80. Higher score indicates higher quality of life.
Cognitive performances
Variation of the performance on serial subtractions tasks: total and correct responses at serials 3s, 7s and 17s. For Serial 3s: Participants will be instructed to count backwards in threes from a given number, as quickly and accurately as possible. For Serial 7s: same task as for serial 3s but with the serial subtraction of 7. Serial 17s: same task as for serial 3s but with the serial subtraction of 17.
Cognitive performances
Variation of the performance on the tracking task : speed and accuracy. In this task participants are required to use the mouse to move a cursor to attempt to track an asterisk which follows a random on-screen path. The distance between the target and the cursor is then computed every 100 ms.
Diurnal cortisol secretion
Variation of cortisone/ cortisol urinary concentrations ratio
Diurnal cortisol metabolism
Variation of allo-tetrahydrocortisol (THFs)/ tetrahydrocortisone (THE) urinary concentrations ratio
Biological response to an acute stressor
Incremental area under the curve (iAUC) of the salivary cortisol concentration and alpha-amylase activity
Psychological response to an acute stressor assessed through the STAI
Variation of the State-Trait Anxiety Inventory (STAI-State) score. Min score: 20; Max score: 80. Higher score corresponds to a higher level of anxiety.
Psychological response to an acute stressor assessed on a Visual Analogical Scale
Variation of the perceived stress scores obtained at a Visual Analogical Scale (VAS). Score range: 0-100. Higher score indicates a higher level of anxiety.
Hemodynamic response to an acute stressor
Maximum increase and incremental area under the curve (iAUC) of the heart rate
Galvanic Skin Response to the acute stressor
Averaged raw score in microSiemens (µS) during exposure to acute stressor, likely to be comprised between 0.5 µS and 5 µS. A higher GSR indicates a higher stress state.

Full Information

First Posted
July 3, 2018
Last Updated
April 9, 2019
Sponsor
Activ'inside
Collaborators
Northumbria University
search

1. Study Identification

Unique Protocol Identification Number
NCT03639831
Brief Title
ACUTE AND CHRONIC EFFECTS OF A BOTANICAL EXTRACT ON ANXIETY, PERCEIVED STRESS, MOOD AND CORTISOL IN HEALTHY ADULTS
Official Title
ACUTE AND CHRONIC EFFECTS OF A PROPRIETARY BOTANICAL EXTRACT ON ANXIETY, PERCEIVED STRESS, MOOD AND CORTISOL SECRETION AND METABOLISM IN HEALTHY ADULTS: RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND CLINICAL TRIAL
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
November 6, 2017 (Actual)
Primary Completion Date
November 15, 2018 (Actual)
Study Completion Date
March 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Activ'inside
Collaborators
Northumbria University

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
Mood disorders, including depression and anxiety, are one of the main causes of the overall disease burden worldwide. In recent years, the efficacy of certain botanicals as an alternative solution for depression has been evaluated in a number of clinical trials. However, only few studies looked at the effects of these botanicals on mood in healthy subjects. The aim of the proposed randomised, double-blind, placebo-controlled, parallel groups methodology is to assess the acute and chronic effects of daily supplementation with a proprietary and standardized botanical extract in comparison to placebo in healthy adults aged 18-60 years with self-reported low mood.
Detailed Description
The chronic effect of the active product on mood, anxiety, perceived stress, quality of life and cortisol secretion & metabolism will be assessed through validated questionnaires and urine collection after 2, 4 and 8 weeks of daily supplementation. The acute effect of the product will be assessed after a single dose and exposure to an acute psychological stressor. Before, during and after the stressor, saliva samples will be collected and subjective levels of anxiety and mood will be measured. In addition, Galvanic Skin Response (GSR) and heart rate (HR) will be measured throughout the stressor session.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mood Disorders
Keywords
Mood, Anxiety, Stress, Dietary supplement, Botanical

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active group
Arm Type
Experimental
Arm Description
Proprietary, standardized botanical extract
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Placebo (maltodextrin)
Intervention Type
Dietary Supplement
Intervention Name(s)
Proprietary, standardized botanical extract
Intervention Description
2 capsules/ day providing the proprietary botanical extract as unique active ingredient
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo (maltodextrin)
Intervention Description
2 capsules/ day providing no active component
Primary Outcome Measure Information:
Title
Mood state
Description
Variation of the Profile of mood states (POMS-2) total score: TMD (Total Mood Disturbance score). The POMS-2 is a scale which includes six mood subscales: Anger, Confusion, Depression, Fatigue, Tension, and Vigor. Each subscale is scored between 0 and 100. TMD is determined by summing the Negative Mood State subscores and subtracting the Vigor subscore (unique Positive Mood State subscale). For each subscale except Vigor, a lower subscore indicates a better mood state. For the Vigor subscale, a higher subscore indicates a better mood state. A lower POMS-2 TMD indicates a better mood state.
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
POMS-2 subscores
Description
Variation of the POMS-2 subscores: Anger, Confusion, Depression, Fatigue, Tension, and Vigor. Each subscale is scored between 0 and 100. For each subscale except Vigor, a lower subscore indicates a better mood state. For the Vigor subscale, a higher subscore indicates a better mood state.
Time Frame
week 2, week 4, week 8
Title
Anxiety state State-Trait Anxiety Inventory
Description
Variation of the State-Trait Anxiety Inventory (STAI-State) score. Min score: 20; Max score: 80. Higher score corresponds to a higher level of anxiety.
Time Frame
week 2, week 4, week 8
Title
Anxiety state according to the Hospital Anxiety and Depression Scale
Description
Variation of the anxiety subscore of the Hospital Anxiety and Depression Scale (HADS-A). Min score: 0; Max score: 21. Higher score corresponds to a higher level of anxiety.
Time Frame
week 2, week 4, week 8
Title
Percentage of responders
Description
A responder is defined as a participant with a statistically significant reduction of the POMS-2 TMD T-score. A lower POMS-2 TMD indicates a better mood state.
Time Frame
week 2, week 4, week 8
Title
Psychological stress
Description
Variation of the Perceived Stress Scale (PSS-10) score (min score: 0; max score: 40; a higher score corresponds to a lower psychological stress feeling)
Time Frame
week 2, week 4, week 8
Title
Worry feeling
Description
Variation of the Penn State Worry Questionnaire score (min score: 16; max score: 80; a higher score corresponds to a higher worry feeling)
Time Frame
week 2, week 4, week 8
Title
Coping response to stress
Description
Variations of the COPE inventory score (min score: 60; max score: 240). A higher score indicates that the subject uses more coping strategies in response to stress.
Time Frame
week 2, week 4, week 8
Title
Depressive-like state
Description
Variation of the depression subscore of the HADS (HADS-D). HADS-D score is comprised between 0 and 21. A higher HADS-D score indicates a higher level of depression.
Time Frame
week 2, week 4, week 8
Title
Quality of life score
Description
Variation of the World Health Organisation Quality of Life questionnaire (WHOQOL-BREF) score, comprised between 16 and 80. Higher score indicates higher quality of life.
Time Frame
week 2, week 4, week 8
Title
Cognitive performances
Description
Variation of the performance on serial subtractions tasks: total and correct responses at serials 3s, 7s and 17s. For Serial 3s: Participants will be instructed to count backwards in threes from a given number, as quickly and accurately as possible. For Serial 7s: same task as for serial 3s but with the serial subtraction of 7. Serial 17s: same task as for serial 3s but with the serial subtraction of 17.
Time Frame
week 2, week 4, week 8
Title
Cognitive performances
Description
Variation of the performance on the tracking task : speed and accuracy. In this task participants are required to use the mouse to move a cursor to attempt to track an asterisk which follows a random on-screen path. The distance between the target and the cursor is then computed every 100 ms.
Time Frame
week 2, week 4, week 8
Title
Diurnal cortisol secretion
Description
Variation of cortisone/ cortisol urinary concentrations ratio
Time Frame
week 2, week 4, week 8
Title
Diurnal cortisol metabolism
Description
Variation of allo-tetrahydrocortisol (THFs)/ tetrahydrocortisone (THE) urinary concentrations ratio
Time Frame
week 2, week 4, week 8
Title
Biological response to an acute stressor
Description
Incremental area under the curve (iAUC) of the salivary cortisol concentration and alpha-amylase activity
Time Frame
week 2, week 4 & week 8; at 15, 30, 45, 60 & 75 min after exposure to the stressor
Title
Psychological response to an acute stressor assessed through the STAI
Description
Variation of the State-Trait Anxiety Inventory (STAI-State) score. Min score: 20; Max score: 80. Higher score corresponds to a higher level of anxiety.
Time Frame
week 2, week 4 & week 8; 30 and 60 min after exposure to the stressor
Title
Psychological response to an acute stressor assessed on a Visual Analogical Scale
Description
Variation of the perceived stress scores obtained at a Visual Analogical Scale (VAS). Score range: 0-100. Higher score indicates a higher level of anxiety.
Time Frame
week 2, week 4 & week 8; 30 and 60 min after exposure to the stressor
Title
Hemodynamic response to an acute stressor
Description
Maximum increase and incremental area under the curve (iAUC) of the heart rate
Time Frame
week 2, week 4 & week 8; 0 to 15 min after exposure to the stressor
Title
Galvanic Skin Response to the acute stressor
Description
Averaged raw score in microSiemens (µS) during exposure to acute stressor, likely to be comprised between 0.5 µS and 5 µS. A higher GSR indicates a higher stress state.
Time Frame
week 2, week 4 & week 8
Other Pre-specified Outcome Measures:
Title
Bioavaialability
Description
Urinary metabolites
Time Frame
week 2, week 4 & week 8
Title
Biomarqueurs of oxidative damage
Description
Change in urine F2-isoprostane
Time Frame
week 2, week 4 & week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: With non-pathological feelings of anxiety and/ or stress in daily life: Subjects self-reporting low mood; Total score ≥ 40 at the Profile of Mood State (POMS 2); Score < 16 at the Generalized Anxiety Disorder 7-item (GAD-7) questionnaire Score ≤ 10 at the Patient Health Questionnaire 9-item (PHQ-9) Not meeting the diagnosis criteria for any mental disorder Body Mass Index (BMI) in the normal range: 18.5 ≥ BMI ≤ 30 kg/ m2 For non-menopausal women: using effective contraception/pregnancy is not physiologically possible. Subject showing no difficulty for salivary sampling Subjects capable of and willing to comply with the protocol and to give their written informed consent Main Exclusion Criteria: Diagnosis of psychological pathology within the previous 3 years Diagnosis of cognitive pathology Anxiolytic or antidepressant treatment, within the previous 3 months Event likely to have impacted the subject's emotional and/ or psychological state within the last 8 weeks or planned during the next 8 weeks Menopausal transition High blood pressure Subjects diagnosed with diabetes, cardiovascular disease, recurrent infectious diseases or chronic inflammatory pathology Usual corticoid treatment/ steroidal anti-inflammatory treatment Unbalanced thyroid disease High physical activity practice Tobacco consumption Subjects consuming any food supplement Excessive alcohol or caffeine use Consumption of recreational drugs Subject currently participating in other clinical or nutrition intervention studies, or has done in the past 4 weeks.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David KENNEDY, PhD
Organizational Affiliation
Brain, Performance and Nutrition Research Centre - Northumbria University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brain, Performance and Nutrition Research Centre, Northumbria University
City
Newcastle upon Tyne
ZIP/Postal Code
NE1 8ST
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33598475
Citation
Jackson PA, Forster J, Khan J, Pouchieu C, Dubreuil S, Gaudout D, Moras B, Pourtau L, Joffre F, Vaysse C, Bertrand K, Abrous H, Vauzour D, Brossaud J, Corcuff JB, Capuron L, Kennedy DO. Effects of Saffron Extract Supplementation on Mood, Well-Being, and Response to a Psychosocial Stressor in Healthy Adults: A Randomized, Double-Blind, Parallel Group, Clinical Trial. Front Nutr. 2021 Feb 1;7:606124. doi: 10.3389/fnut.2020.606124. eCollection 2020.
Results Reference
derived

Learn more about this trial

ACUTE AND CHRONIC EFFECTS OF A BOTANICAL EXTRACT ON ANXIETY, PERCEIVED STRESS, MOOD AND CORTISOL IN HEALTHY ADULTS

We'll reach out to this number within 24 hrs