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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05591885
Other study ID # IS20220006RD
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 24, 2022
Est. completion date May 31, 2023

Study information

Verified date April 2023
Source Amway (China) R&D Center
Contact Wenan Wang, MD
Phone 13611641232
Email 13611641232@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date May 31, 2023
Est. primary completion date May 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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 group
During study intervention, subjects are required to take the randomly assigned placebo following the instructions.Take one tablet twice daily with meals.

Locations

Country Name City State
China Kangrong Clinic Jinhua Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Amway (China) R&D Center

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mini-Mental State Examination Change of mental status after 90-days product intervention endpoint( day 90)
Primary 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 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary Montreal Cognitive Assessment; Test Cognitive Ability baseline(day 0)/interim ( day 45)/endpoint( day 90)
Secondary 72-hrs Food Recall 72-hours food recall of subjects baseline(day 0)/interim ( day 45)/endpoint( day 90)
Secondary Sport Frequency Questionnaire Record the exercise frequency and duration within one week, without any score. baseline(day 0)/interim ( day 45)/endpoint( day 90)
Secondary Blood blood routine test (red blood cell count, white blood cell count, platelet count,hemoglobin) baseline(day 0)/endpoint( day 90)
Secondary Urine Urine routine test(Leukocyte, Urine Protein, Ketone Body) baseline(day 0)/endpoint( day 90)
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