Cognitive Function
Conditions
Keywords
MMSE, MoCA, WMS-R, Cognitrax Test
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTStudy 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.
DIETARY_SUPPLEMENTPlacebo group
During study intervention, subjects are required to take the randomly assigned placebo following the instructions.Take one tablet twice daily with meals.
Sponsors
Amway (China) R&D Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mini-Mental State Examination | endpoint( day 90) | Change of mental status after 90-days product intervention |
| Wechsler Memory Scale RC | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Scale | 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. |
| Activities of Daily Living Scale | 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. |
| Verbal Memory Test of Cognitrax Test | baseline(day 0)/interim ( day 45)/endpoint( day 90) | Use the official website(www.cnsvs.com) to test subjects' verbal memory |
| Finger Tapping Test of Cognitrax Test | baseline(day 0)/interim ( day 45)/endpoint( day 90) | Use the official website(www.cnsvs.com) to test subjects' finger movement |
| Symbol Digit Coding Test of Cognitrax Test | 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. |
| Stroop Test of Cognitrax Test | baseline(day 0)/interim ( day 45)/endpoint( day 90) | Use the official website(www.cnsvs.com) to test subjects' memory and attention. |
| Blood | baseline(day 0)/endpoint( day 90) | blood routine test （red blood cell count, white blood cell count, platelet count，hemoglobin） |
| Continuous Performance Test of Cognitrax Test | baseline(day 0)/interim ( day 45)/endpoint( day 90) | Use the official website(www.cnsvs.com) to test subjects' different aspects of attention. |
| Four-part Continuous Performance Test of Cognitrax Test | baseline(day 0)/interim ( day 45)/endpoint( day 90) | Use the official website(www.cnsvs.com) to test subjects' cognitive ability. |
| Montreal Cognitive Assessment; | baseline(day 0)/interim ( day 45)/endpoint( day 90) | Test Cognitive Ability |
| 72-hrs Food Recall | baseline(day 0)/interim ( day 45)/endpoint( day 90) | 72-hours food recall of subjects |
| Sport Frequency Questionnaire | baseline(day 0)/interim ( day 45)/endpoint( day 90) | Record the exercise frequency and duration within one week, without any score. |
| Shifting Attention Test of Cognitrax Test | 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. |
| Urine | baseline(day 0)/endpoint( day 90) | Urine routine test（Leukocyte, Urine Protein, Ketone Body） |
Countries
China
Contacts
Primary ContactWenan Wang, MD
Outcome results
None listed