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OpenTrials
Completed

NCT Number: NCT05520424

An Exploratory Investigation of a Supplement to Promote Brain Health

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.

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Key information

Conditions

Memory Deficits Cognitive Change Memory Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Stress

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Citruslabs

Santa Monica, California, 90404, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. Changes in Cognitive Functioning

    Time frame: 31 days

    Cognitive battery questionnaires measure executive functioning, long term memory, working memory, and attention.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Parable

Industry

Collaborators

  • Citruslabs

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 29, 2022
Registry last updated
Apr 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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