An Exploratory Investigation of a Supplement to Promote Brain Health

NCT05520424 | Completed

• 1 other identifier: 20251
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Memory Deficits; Cognitive Change; Stress

Keywords

Focus; Memory; Attention; Stress

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Changes in Cognitive Functioning

  31 days

Other Outcomes (1)

• Changes in plasma/serum biomarkers associated with brain health

  31 days

Study Arms (1)

The Daily Supplement

EXPERIMENTAL

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

Interventions

The Daily Supplement DIETARY_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)

The Daily Supplement

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Parable: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Memory Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christopher Hill, PhD

  Citruslabs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2022
• First Posted: August 29, 2022
• Study Start: June 15, 2022
• Primary Completion: October 30, 2022
• Study Completion: October 30, 2022
• Last Updated: April 3, 2024

Record last verified: 2024-04

Locations

US (1)