An Exploratory Investigation of a Supplement to Promote Brain Health

Stress Clinical Trial

Official title:

An Exploratory Investigation of a Supplement to Promote Brain Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05520424
• Other study ID #: 20251
• Status: Completed
• Phase: N/A
• Start date: June 15, 2022
• Est. completion date: October 30, 2022

Study information

• Verified date: April 2024
• Source: Parable
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 30, 2022
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Change
• Memory Deficits
• Memory Disorders
• Stress

Intervention

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)

Locations

Country	Name	City	State
United States	Citruslabs	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
Parable	Citruslabs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in plasma/serum biomarkers associated with brain health	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
Primary	Perceived changes in mental health symptoms as measured by Questionnaires	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
Primary	Perceived changes in stress management as measured by Questionnaires	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	Changes in Cognitive Functioning	Cognitive battery questionnaires measure executive functioning, long term memory, working memory, and attention.	31 days