Nutrilite Memory Builder on the Improvement of Cognitive Function

April 26, 2023 updated by: Amway (China) R&D Center

The Effect of Nutrilite Memory Builder on the Improvement of Cognitive Function: A Randomized Controlled Trial(RCT)

Its a randomized controlled trial, to evaluate the effect of NUTRILITE Memory Builder on the improvement of cognitive function in middle-aged and elderly people.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
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.

Detailed Description

The study center will recruit 100 male or female subjects aged 40-75 years as needed. Enrolled subjects will be divided into 2 groups, with 50 subjects in each group.

Study subjects will be administrated with either the Amway product or a placebo for three months (12 weeks). At least 42 subjects in each group (84 in total) are required to complete the study.

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 (Anticipated)

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.
100

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Zhejiang
      • Jinhua, Zhejiang, China, 321041
        • Recruiting
        • Kangrong Clinic
        • Principal Investigator:
          • Wenan Wang, Professor

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

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Males or females, 40-75 years old (with age groups of 40-60 years and 61-75 years as close as possible to a 1:1 ratio);
  • Healthy subjects with no underlying diseases and no drug treatment at the time of screening;
  • Meet the requirements of MMSE scores of 24-29;
  • Be willing to comply with all study requirements and procedures;
  • Agree to sign the informed consent form.

Exclusion Criteria:

  • Participated in similar clinical trials in the last 6 months;
  • Have mental illness or disorders of consciousness and behavior;
  • Have severe chronic diseases and are currently under treatment with drugs;
  • Have taken drugs that can affect cognitive function (such as first-generation antihistamines, benzodiazepines, sedatives, opiates, stabilizers, antidepressants, cholinergic drugs, anticholinergic drugs, prescription anti-inflammatory drugs) and any other regularly influential agents.
  • Had flu/virus symptoms within 3 months before screening;
  • Received within 3 months before screening or currently receiving medical or nutritional treatments, including protein supplementation or substances that provide exercise capacity;
  • Had weight gain or weight loss of more than 5kg within 3 months before screening;
  • Have a history of hospitalization within 3 months before screening;
  • Have any of the following medical history or have been clinically diagnosed with any of the following diseases: obvious gastrointestinal disorders; liver, kidney, endocrine, blood, respiratory and cardiovascular diseases. These may affect the assessment of product efficacies.
  • Have high daily alcohol consumption, i.e. more than 14 bottles of beer (350 ml/bottle) or wine (180 ml/bottle) per week;
  • The PI believes that the subjects cannot fully cooperate with the trial arrangement.

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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: Study product gruop
Nutrilite Memory Builder Ingredients (Cistanche deserticola extract, Ginkgo biloba extract, glucose, microcrystalline cellulose, corn starch, etc.) 60 Tablets / bottle
Dietary supplement: Study product group (Nutrilite Memory Builder)
During study intervention, subjects are required to take the randomly assigned study product following the instructions.Take one tablet twice daily with meals.
Placebo Comparator: Placebo group
Ingredients (glucose, microcrystalline cellulose, corn starch, caramel pigment, etc.) 60 Tablets / bottle
Dietary supplement: Placebo group
During study intervention, subjects are required to take the randomly assigned placebo following the instructions.Take one tablet twice daily with meals.

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
Mini-Mental State Examination
Time Frame: endpoint( day 90)
Change of mental status after 90-days product intervention
endpoint( day 90)
Wechsler Memory Scale RC
Time Frame: endpoint( day 90)
Change of memory after 90-days product intervention. A complete set of memory evaluation tools with 10 subscales measured three aspects of participants' long-term, short-term and instantaneous memory, which added three sub-tests to WMS. Among them, there are 3 sub-tests of long-term memory, namely personal experience, orientation, and numerical order; There are 6 sub-tests for short-term memory, namely visual rerecognition, picture recall, visual regeneration, associative learning, touch, and comprehension; Instantaneous memory has only 1 sub-test, i.e. reciting numbers in a forward and backward manner. Scoring uses the Memory Quotient (MQ) method, where higher MQ values indicate better memory ability.
endpoint( day 90)

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
Quality of Life Scale
Time Frame: baseline(day 0)/interim ( day 45)/endpoint( day 90)
Record the data of the subjects' life quality,The quality score is 60 points, the good is 51-60 points, the good is 41-50 points, the general is 31-40 points, the poor is 21-30 points, and the quality of life is < 20 points.
baseline(day 0)/interim ( day 45)/endpoint( day 90)
Activities of Daily Living Scale
Time Frame: baseline(day 0)/interim ( day 45)/endpoint( day 90)
Record the data of the subjects' activities of daily living；The scoring results can be divided into four grades: grade 0=self-care: 100 points, good ability of daily living activities, without help from others grade=mild dysfunction: 99-61 points, able to independently complete some daily activities, but need help; Level II=moderate dysfunction: 60-41 points, need great help to complete activities of daily living Level III=severe dysfunction: ≤ 40 points, most activities of daily living can not be completed completely need care.
baseline(day 0)/interim ( day 45)/endpoint( day 90)
Verbal Memory Test of Cognitrax Test
Time Frame: baseline(day 0)/interim ( day 45)/endpoint( day 90)
Use the official website(www.cnsvs.com) to test subjects' verbal memory
baseline(day 0)/interim ( day 45)/endpoint( day 90)
Finger Tapping Test of Cognitrax Test
Time Frame: baseline(day 0)/interim ( day 45)/endpoint( day 90)
Use the official website(www.cnsvs.com) to test subjects' finger movement
baseline(day 0)/interim ( day 45)/endpoint( day 90)
Symbol Digit Coding Test of Cognitrax Test
Time Frame: baseline(day 0)/interim ( day 45)/endpoint( day 90)
Use the official website(www.cnsvs.com) to test subjects' processing speed, working memory, visuospatial processing, and attention.
baseline(day 0)/interim ( day 45)/endpoint( day 90)
Stroop Test of Cognitrax Test
Time Frame: baseline(day 0)/interim ( day 45)/endpoint( day 90)
Use the official website(www.cnsvs.com) to test subjects' memory and attention.
baseline(day 0)/interim ( day 45)/endpoint( day 90)
Shifting Attention Test of Cognitrax Test
Time Frame: baseline(day 0)/interim ( day 45)/endpoint( day 90)
Use the official website(www.cnsvs.com) to test subjects' measures the subject s ability to shift from one instruction set to another quickly and accurately.
baseline(day 0)/interim ( day 45)/endpoint( day 90)
Continuous Performance Test of Cognitrax Test
Time Frame: baseline(day 0)/interim ( day 45)/endpoint( day 90)
Use the official website(www.cnsvs.com) to test subjects' different aspects of attention.
baseline(day 0)/interim ( day 45)/endpoint( day 90)
Four-part Continuous Performance Test of Cognitrax Test
Time Frame: baseline(day 0)/interim ( day 45)/endpoint( day 90)
Use the official website(www.cnsvs.com) to test subjects' cognitive ability.
baseline(day 0)/interim ( day 45)/endpoint( day 90)
Montreal Cognitive Assessment;
Time Frame: baseline(day 0)/interim ( day 45)/endpoint( day 90)
Test Cognitive Ability
baseline(day 0)/interim ( day 45)/endpoint( day 90)
72-hrs Food Recall
Time Frame: baseline(day 0)/interim ( day 45)/endpoint( day 90)
72-hours food recall of subjects
baseline(day 0)/interim ( day 45)/endpoint( day 90)
Sport Frequency Questionnaire
Time Frame: baseline(day 0)/interim ( day 45)/endpoint( day 90)
Record the exercise frequency and duration within one week, without any score.
baseline(day 0)/interim ( day 45)/endpoint( day 90)
Blood
Time Frame: baseline(day 0)/endpoint( day 90)
blood routine test （red blood cell count, white blood cell count, platelet count，hemoglobin）
baseline(day 0)/endpoint( day 90)
Urine
Time Frame: baseline(day 0)/endpoint( day 90)
Urine routine test（Leukocyte, Urine Protein, Ketone Body）
baseline(day 0)/endpoint( day 90)

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.
Amway (China) R&D Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Wenan Wang, MD, Shanghai Jiao Tong University School of Medicine

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.
October 24, 2022

Primary Completion (Anticipated)

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.
May 31, 2023

Study Completion (Anticipated)

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.
May 31, 2023

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).
October 12, 2022

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.
October 21, 2022

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.
October 24, 2022

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.
April 28, 2023

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.
April 26, 2023

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.
April 1, 2023

More Information

Terms related to this study

Keywords

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.
  • IS20220006RD

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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