A Clinical Trial to Investigate the Efficacy of a Supplement to Improve and Maintain Cognitive Function and Memory

NCT06523218 | Active Not Recruiting

• 1 other identifier: 20429
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the efficacy of 1MD Nutrition's MindMD supplement in improving and maintaining cognitive function and memory. The randomized controlled trial will include 50 healthy participants aged 50-75 years, lasting for 3 months. Participants will be randomized to receive either the test product or a placebo.

Conditions

Cognitive Decline; Cognitive Function

Keywords

Cognitive Health; Healthy Aging

Outcome Measures

Primary Outcomes (1)

• Cognitive Function and Memory Improvement

  Measurement of cognitive function and memory through Cognitive Battery Testing. The Cognitive Battery Testing includes assessments such as Polygons, Double Trouble, Feature Match, Paired Associates, Digit Span, and Spatial Planning. These assessments provide objective measurements of various cognitive functions, including processing speed, memory recall, selective attention, and executive function.

  Baseline, Month 2, and Month 3

Secondary Outcomes (3)

• Participants' Perceptions of Cognitive Function and Memory using the Cognitive Function Questionnaire

  Baseline, Month 1, Month 2, and Month 3

• Participants' Quality of Life

  Baseline, Month 1, Month 2, and Month 3

• Participants' Focus and Attentiveness

  Baseline, Month 1, Month 2, and Month 3

Study Arms (2)

MindMD Supplement

EXPERIMENTAL

Participants in the experimental group will receive the MindMD supplement, which contains the following ingredients: 600 mg Bacopa monnieri (Bacognize®), 250 mg Cognigrape® Grape Extract, 100 mg Phosphatidylserine, 50 mg Green Tea Leaf Extract, 1.7 mg Vitamin B6, and 200 mcg Folate (120 mcg folic acid).

Dietary Supplement: MindMD Supplement

Placebo

PLACEBO COMPARATOR

Participants in the placebo group will receive a placebo, which contains rice flour encapsulated in a vegetable cellulose capsule.

Other: Placebo

Interventions

MindMD Supplement DIETARY_SUPPLEMENT

Participants will take two capsules of the MindMD supplement once daily with their morning meal for a duration of 3 months. The supplement is designed to improve and maintain cognitive function and memory.

MindMD Supplement

Placebo OTHER

Participants will take two capsules of the placebo once daily with their morning meal for a duration of 3 months. The placebo is designed to be indistinguishable in appearance and administration from the MindMD supplement to ensure blinding.

Placebo

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 50-75 years
• Regular experience of symptoms related to cognitive decline (e.g., forgetfulness, lack of focus, brain fog)
• Generally healthy without uncontrolled chronic diseases
• Willingness to avoid certain medications and supplements during the study

You may not qualify if:

• Any medical condition or treatment impacting cognitive ability Mental health or neurological disorders
• Severe allergies, particularly to soy or other product ingredients
• Taking blood thinning medication
• Recent or planned surgeries
• Major illness in the past three months

Sponsors & Collaborators

• Scale Media Inc: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 26, 2024
• Study Start: May 17, 2024
• Primary Completion: August 17, 2024
• Study Completion: August 17, 2024
• Last Updated: July 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)