Nutrilite Memory Builder on the Improvement of Cognitive Function

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cognitive Function

Intervention / Treatment
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* Dietary Supplement: Study product group (Nutrilite Memory Builder)
* Dietary Supplement: Placebo group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized controlled trial: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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study product gruop<br>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)<br>* During study intervention, subjects are required to take the randomly assigned study product following the instructions.Take one tablet twice daily with meals.<br>|
| Placebo Comparator: Placebo group<br>Ingredients (glucose, microcrystalline cellulose, corn starch, caramel pigment, etc.) 60 Tablets / bottle | Dietary Supplement: Placebo group<br>* During study intervention, subjects are required to take the randomly assigned placebo following the instructions.Take one tablet twice daily with meals.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mini-Mental State Examination | Change of mental status after 90-days product intervention | endpoint( day 90) | 
| Wechsler Memory Scale RC | 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life Scale | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Use the official website(www.cnsvs.com) to test subjects' cognitive ability. | baseline(day 0)/interim ( day 45)/endpoint( day 90) | 
| Montreal Cognitive Assessment; | Test Cognitive Ability | baseline(day 0)/interim ( day 45)/endpoint( day 90) | 
| 72-hrs Food Recall | 72-hours food recall of subjects | baseline(day 0)/interim ( day 45)/endpoint( day 90) | 
| Sport Frequency Questionnaire | Record the exercise frequency and duration within one week, without any score. | baseline(day 0)/interim ( day 45)/endpoint( day 90) | 
| Blood | blood routine test （red blood cell count, white blood cell count, platelet count，hemoglobin） | baseline(day 0)/endpoint( day 90) | 
| Urine | Urine routine test（Leukocyte, Urine Protein, Ketone Body） | baseline(day 0)/endpoint( day 90) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MMSE, MoCA, WMS-R, Cognitrax Test