Nutrilite Memory Builder on the Improvement of Cognitive Function

NCT05591885 | Unknown DMC

• 1 other identifier: IS20220006RD
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Function

Keywords

MMSE; MoCA; WMS-R; Cognitrax Test

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• Quality of Life Scale

  baseline(day 0)/interim ( day 45)/endpoint( day 90)

• Activities of Daily Living Scale

  baseline(day 0)/interim ( day 45)/endpoint( day 90)

• Verbal Memory Test of Cognitrax Test

  baseline(day 0)/interim ( day 45)/endpoint( day 90)

• Finger Tapping Test of Cognitrax Test

  baseline(day 0)/interim ( day 45)/endpoint( day 90)

• Symbol Digit Coding Test of Cognitrax Test

  baseline(day 0)/interim ( day 45)/endpoint( day 90)

Study Arms (2)

Study product gruop

EXPERIMENTAL

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)

Placebo group

PLACEBO COMPARATOR

Ingredients (glucose, microcrystalline cellulose, corn starch, caramel pigment, etc.) 60 Tablets / bottle

Dietary Supplement: Placebo group

Interventions

Study product group (Nutrilite Memory Builder) DIETARY_SUPPLEMENT

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

Study product gruop

Placebo group DIETARY_SUPPLEMENT

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

Placebo group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amway (China) R&D Center: lead

Study Sites (1)

Kangrong Clinic

Jinhua, Zhejiang, 321041, China

RECRUITING

Study Officials

• Wenan Wang, MD

  Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenan Wang, MD

CONTACT

13611641232; 13611641232@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 24, 2022
• Study Start: October 24, 2022
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: April 28, 2023

Record last verified: 2023-04

Locations

CN (1)