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

Not Applicable

Active, not recruiting

• Conditions: Cognitive Function; Cognitive Decline
• Interventions: Other: Placebo; Dietary Supplement: MindMD Supplement

• Registration Number: NCT06523218
• Lead Sponsor: Scale Media Inc

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-17
• Status Verified: 2024-07
• Study First Submitted: 2024-07-17
• Study First Submitted QC: 2024-07-25
• Last Update Submitted: 2024-07-25
• Study First Posted: 2024-07-26
• Last Update Posted: 2024-07-26
• Primary Completion: 2024-08-17
• Study Completion: 2024-08-17

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants in the placebo group will receive a placebo, which contains rice flour encapsulated in a vegetable cellulose capsule.
MindMD Supplement	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).

Primary Outcome Measures

Name	Time	Method
Cognitive Function and Memory Improvement	Baseline, Month 2, and Month 3	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.

Secondary Outcome Measures

Name	Time	Method
Participants' Perceptions of Cognitive Function and Memory using the Cognitive Function Questionnaire	Baseline, Month 1, Month 2, and Month 3	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.
Participants' Focus and Attentiveness	Baseline, Month 1, Month 2, and Month 3	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.
Participants' Quality of Life	Baseline, Month 1, Month 2, and Month 3	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.

Trial Locations

Locations (1)

Citruslabs; 🇺🇸 Santa Monica, California, United States