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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
100
During study intervention, subjects are required to take the randomly assigned study product following the instructions.Take one tablet twice daily with meals.
During study intervention, subjects are required to take the randomly assigned placebo following the instructions.Take one tablet twice daily with meals.
Kangrong Clinic
Jinhua, Zhejiang, China
RECRUITINGMini-Mental State Examination
Change of mental status after 90-days product intervention
Time frame: 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.
Time frame: endpoint( day 90)
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.
Time frame: 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.
Time frame: baseline(day 0)/interim ( day 45)/endpoint( day 90)
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Verbal Memory Test of Cognitrax Test
Use the official website(www.cnsvs.com) to test subjects' verbal memory
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline(day 0)/interim ( day 45)/endpoint( day 90)
Montreal Cognitive Assessment;
Test Cognitive Ability
Time frame: baseline(day 0)/interim ( day 45)/endpoint( day 90)
72-hrs Food Recall
72-hours food recall of subjects
Time frame: baseline(day 0)/interim ( day 45)/endpoint( day 90)
Sport Frequency Questionnaire
Record the exercise frequency and duration within one week, without any score.
Time frame: baseline(day 0)/interim ( day 45)/endpoint( day 90)
Blood
blood routine test （red blood cell count, white blood cell count, platelet count，hemoglobin）
Time frame: baseline(day 0)/endpoint( day 90)
Urine
Urine routine test（Leukocyte, Urine Protein, Ketone Body）
Time frame: baseline(day 0)/endpoint( day 90)