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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study product gruop | Experimental | Nutrilite Memory Builder Ingredients (Cistanche deserticola extract, Ginkgo biloba extract, glucose, microcrystalline cellulose, corn starch, etc.) 60 Tablets / bottle |
|
| Placebo group | Placebo Comparator | Ingredients (glucose, microcrystalline cellulose, corn starch, caramel pigment, etc.) 60 Tablets / bottle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Study product group (Nutrilite Memory Builder) | Dietary Supplement | During study intervention, subjects are required to take the randomly assigned study product following the instructions.Take one tablet twice daily with meals. |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenan Wang, MD | Contact | 13611641232 | 13611641232@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Wenan Wang, MD | Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kangrong Clinic | Recruiting | Jinhua | Zhejiang | 321041 | China |
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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.
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| Placebo group | Dietary Supplement | During study intervention, subjects are required to take the randomly assigned placebo following the instructions.Take one tablet twice daily with meals. |
|
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) |