Nutrilite Memory Builder on the Improvement of Cognitive Function

Cognitive Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05591885
• Other study ID #: IS20220006RD
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Cognitive Function

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)