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

July 25, 2024 updated by: Scale Media Inc
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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cognitive Function and Memory Improvement
Time Frame: 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.
Baseline, Month 2, and Month 3

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Participants' Perceptions of Cognitive Function and Memory using the Cognitive Function Questionnaire
Time Frame: 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.
Baseline, Month 1, Month 2, and Month 3
Participants' Quality of Life
Time Frame: 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.
Baseline, Month 1, Month 2, and Month 3
Participants' Focus and Attentiveness
Time Frame: 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.
Baseline, Month 1, Month 2, and Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Scale Media Inc

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Citruslabs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 17, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 17, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 17, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 17, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 26, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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