Nutrilite Memory Builder on the Improvement of Cognitive Function

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cognitive Function
• Intervention / Treatment: Dietary supplement: Study product group (Nutrilite Memory Builder); Dietary supplement: Placebo group

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wenan Wang, MD; Phone Number: 13611641232; Email: 13611641232@163.com

Study Locations

• China
  • Zhejiang
    • Jinhua, Zhejiang, China, 321041
      • Recruiting
      • Kangrong Clinic
      • Principal Investigator: Wenan Wang, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study product gruop; Nutrilite Memory Builder Ingredients (Cistanche deserticola extract, Ginkgo biloba extract, glucose, microcrystalline cellulose, corn starch, etc.) 60 Tablets / bottle	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 Comparator: Placebo group; Ingredients (glucose, microcrystalline cellulose, corn starch, caramel pigment, etc.) 60 Tablets / bottle	Dietary supplement: Placebo group; During study intervention, subjects are required to take the randomly assigned placebo following the instructions.Take one tablet twice daily with meals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Amway (China) R&D Center
• Investigators: Principal Investigator: Wenan Wang, MD, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2022
• Primary Completion (Anticipated): May 31, 2023
• Study Completion (Anticipated): May 31, 2023

Study Registration Dates

• First Submitted: October 12, 2022
• First Submitted That Met QC Criteria: October 21, 2022
• First Posted (Actual): October 24, 2022

Study Record Updates

• Last Update Posted (Actual): April 28, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: MoCA; MMSE; WMS-R; Cognitrax Test
• Other Study ID Numbers: IS20220006RD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No