An Exploratory Investigation of a Supplement to Promote Cognitive Health Benefits
Primary Purpose
Anxiety, Stress, Memory Deficits
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Heights Smart Supplement
Sponsored by
About this trial
This is an interventional other trial for Anxiety focused on measuring memory, stress, anxiety, mood, focus
Eligibility Criteria
Inclusion Criteria:
- In good general health with no major chronic conditions
- Must experience one of the following issues: brain fog
- OR issues with fatigue,
- OR sleep issues,
- OR trouble with focus and concentration,
- OR lead a busy, stressful life.
- Must have a fitness tracker that they use to track sleep behaviors.
- May be on a vegan/vegetarian diet
Exclusion Criteria:
- Females who are pregnant or breastfeeding
- Anyone currently taking other supplements focused on brain health, or multi vitamins, including additional iron supplements
- Anyone taking Thyroxine and Levothyroxine
- Anyone taking antidepressants (such as Sertraline or SSRIs like fluoxetine)
- Anyone on hormone replacement therapy
- Anyone taking blood pressure medication (such as linosipril)
- Anyone with a known allergic reaction
- Any chronic conditions, including oncological and psychiatric disorders
Sites / Locations
- Citruslabs
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Heights Smart Supplement
Arm Description
Participants will take the supplement over a 12 week period. There will be both biomarker outcomes and subjective outcomes reported by the participants via questionnaires.
Outcomes
Primary Outcome Measures
Changes in Measures of C-reactive protein
Biomarkers measured by a third party lab through blood samples submitted by participants.
Changes in Measures of cortisol
Biomarkers measured by a third party lab through blood samples submitted by participants.
Changes in Sleep Quality as measured via Fitness trackers and Questionnaires
Measurements taken via existing smart watches and report that data on the questionnaires.
Secondary Outcome Measures
examine the subjective experiences of participants taking the Heights Smart Supplement.
The questionnaires for this study are specifically designed to understand changes in focus, anxiety embedded in mood & stress, memory, and overall well-being.
Full Information
NCT ID
NCT05523115
First Posted
August 26, 2022
Last Updated
November 7, 2022
Sponsor
Heights
Collaborators
Citruslabs
1. Study Identification
Unique Protocol Identification Number
NCT05523115
Brief Title
An Exploratory Investigation of a Supplement to Promote Cognitive Health Benefits
Official Title
An Exploratory Investigation of a Supplement to Promote Cognitive Health Benefits
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
June 15, 2022 (Actual)
Primary Completion Date
October 1, 2022 (Actual)
Study Completion Date
October 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Heights
Collaborators
Citruslabs
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 Smart Supplement has 20 vitamins and minerals that have strong track records of demonstrating positive health effects, both physiologically and cognitively. This twelve-week trial will examine the effectiveness and efficacy of Heights Smart Supplement on both biomarkers and subjective experiences from participants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Stress, Memory Deficits, Cortisol Overproduction
Keywords
memory, stress, anxiety, mood, focus
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Heights Smart Supplement
Arm Type
Experimental
Arm Description
Participants will take the supplement over a 12 week period. There will be both biomarker outcomes and subjective outcomes reported by the participants via questionnaires.
Intervention Type
Dietary Supplement
Intervention Name(s)
Heights Smart Supplement
Intervention Description
The ingredient list of the product includes the following:
Algae oil Blueberry Extract Methylcobalamin (Vitamin B12) Cholecalciferol (Vitamin D3) Ascorbic acid (Vitamin C) Retinol acetate (Vitamin A) Calcium L-methylfolate (Folic Acid) D-biotin Pyridoxine hydrochloride (Vitamin B6) Calcium pantothenate (Vitamin B5) Nicotinamide (Vitamin B3) Riboflavin (Vitamin B2) Thiamine hydrochloride (Vitamin B1) D-Alpha tocopheryl acetate (Vitamin E) Chromium picolinate Potassium iodide Iron Citrate Sodium selenite Zinc citrate
Primary Outcome Measure Information:
Title
Changes in Measures of C-reactive protein
Description
Biomarkers measured by a third party lab through blood samples submitted by participants.
Time Frame
12 weeks
Title
Changes in Measures of cortisol
Description
Biomarkers measured by a third party lab through blood samples submitted by participants.
Time Frame
12 weeks
Title
Changes in Sleep Quality as measured via Fitness trackers and Questionnaires
Description
Measurements taken via existing smart watches and report that data on the questionnaires.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
examine the subjective experiences of participants taking the Heights Smart Supplement.
Description
The questionnaires for this study are specifically designed to understand changes in focus, anxiety embedded in mood & stress, memory, and overall well-being.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
In good general health with no major chronic conditions
Must experience one of the following issues: brain fog
OR issues with fatigue,
OR sleep issues,
OR trouble with focus and concentration,
OR lead a busy, stressful life.
Must have a fitness tracker that they use to track sleep behaviors.
May be on a vegan/vegetarian diet
Exclusion Criteria:
Females who are pregnant or breastfeeding
Anyone currently taking other supplements focused on brain health, or multi vitamins, including additional iron supplements
Anyone taking Thyroxine and Levothyroxine
Anyone taking antidepressants (such as Sertraline or SSRIs like fluoxetine)
Anyone on hormone replacement therapy
Anyone taking blood pressure medication (such as linosipril)
Anyone with a known allergic reaction
Any chronic conditions, including oncological and psychiatric disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Hill, PhD
Organizational Affiliation
Citruslabs
Official's Role
Principal Investigator
Facility Information:
Facility Name
Citruslabs
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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An Exploratory Investigation of a Supplement to Promote Cognitive Health Benefits
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