An Exploratory Investigation of a Supplement to Promote Brain Health

April 1, 2024 updated by: Parable
Providing a combination of synergistic dietary supplements, such as vitamins B6, B12, and folate, as well as curcumin, lemon balm, and American ginseng is hypothesized to promote brain health and aid with brain fog, mental clarity, ability to handle stress, mood, focus, and productivity, as well as promote overall well-being.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Santa Monica, California, United States, 90404
        • Citruslabs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • In good general health with no major chronic conditions (e.g., diabetes, coronary heart disease, etc.)

Exclusion Criteria:

  • Females who are pregnant or breastfeeding
  • Anyone currently taking other supplements
  • Anyone with a known allergic reaction
  • Previous head trauma
  • Anyone with chronic diseases such as diabetes, coronary heart disease, or cancer.
  • Any psychological, mental, or neurodevelopmental disorders
  • Consumes nicotine or marijuana in any form
  • Previous or current alcohol addiction
  • Consume more than 10 drinks per week

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The Daily Supplement
Participants will use test product daily, and complete Biomarker assessments (at 1st dose, Day 7, Day 31), as well as surveys (at 1st dose, Day 7, Day 31), and Cognitive battery Assessments (at 1st dose, Day 7, Day 31).
Dietary supplement: The Daily Supplement

The ingredient list of the product includes the following:

400mg of curcumin (Longvida) 300mg of lemon balm extract (Cyracos) 200mg of American ginseng (Cereboost) 50mg of epigallocatechin gallate derived from green tea Organic oat milk powder Phosphatidylserine (SerinAid) (active) B6 (in the form of P5P) Folate (Quatrefolic) B12 Silica (non-active)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived changes in mental health symptoms as measured by Questionnaires
Time Frame: 31 days
Questionnaires measure perceived changes in mental health symptoms (e.g., anxiety levels, mental clarity) and stress management on a scale of 0 (low levels of mental health symptoms) to 10 (very high levels of mental health symptoms)
31 days
Perceived changes in stress management as measured by Questionnaires
Time Frame: 31 days
Questionnaires measure perceived changes in stress management on a scale of 0 (poor ability to manage stress) to 10 (excellent ability to manage stress)
31 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Cognitive Functioning
Time Frame: 31 days
Cognitive battery questionnaires measure executive functioning, long term memory, working memory, and attention.
31 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in plasma/serum biomarkers associated with brain health
Time Frame: 31 days
Biomarkers collected via. blood sample sent to a third party lab. The biomarkers of interest for this trial include hs-CRP, HbA1c, homocysteine, and IL-6.
31 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Parable

Collaborators

Citruslabs

Investigators

  • Principal Investigator: Christopher Hill, PhD, Citruslabs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2022

Primary Completion (Actual)

October 30, 2022

Study Completion (Actual)

October 30, 2022

Study Registration Dates

First Submitted

August 26, 2022

First Submitted That Met QC Criteria

August 26, 2022

First Posted (Actual)

August 29, 2022

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20251

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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