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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cognitive Function; Cognitive Decline
• Intervention / Treatment: Dietary supplement: MindMD Supplement; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MindMD Supplement; 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; 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.
Placebo Comparator: Placebo; Participants in the placebo group will receive a placebo, which contains rice flour encapsulated in a vegetable cellulose capsule.	Other: Placebo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants' Perceptions of Cognitive Function and Memory using the Cognitive Function Questionnaire	Evaluation of participants' self-reported perceptions of the effect of the MindMD supplement on cognitive function and memory. This includes aspects such as focus and attentiveness, comprehension and mental clarity, learning acuity, absentmindedness, and overall quality of life. These perceptions will be measured through the Cognitive Function Questionnaire (CFQ) at specified time points: Baseline (Day 0), Month 1, Month 2, and Month 3.	Baseline, Month 1, Month 2, and Month 3
Participants' Quality of Life	Assessment of participants' quality of life using the WHO-5 Well-Being Index. These assessments will be conducted at Baseline (Day 0), Month 1, Month 2, and Month 3.	Baseline, Month 1, Month 2, and Month 3
Participants' Focus and Attentiveness	Evaluation of participants' focus and attentiveness using the Visual Analog Scale (VAS). These assessments will be conducted at Baseline (Day 0), Month 1, Month 2, and Month 3.	Baseline, Month 1, Month 2, and Month 3

Collaborators and Investigators

• Sponsor: Scale Media Inc
• Collaborators: Citruslabs

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2024
• Primary Completion (Estimated): August 17, 2024
• Study Completion (Estimated): August 17, 2024

Study Registration Dates

• First Submitted: July 17, 2024
• First Submitted That Met QC Criteria: July 25, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Actual): July 26, 2024
• Last Update Submitted That Met QC Criteria: July 25, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Healthy Aging; Cognitive Health
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 20429

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No