Nutrilite Memory Builder on the Improvement of Cognitive Function

NCT ID: NCT05591885

Last Updated: 2023-04-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-24
• Study Completion Date: 2023-05-31

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.

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.

Conditions

Cognitive Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Study product gruop

Nutrilite Memory Builder Ingredients (Cistanche deserticola extract, Ginkgo biloba extract, glucose, microcrystalline cellulose, corn starch, etc.) 60 Tablets / bottle

Group Type: EXPERIMENTAL

Study product group (Nutrilite Memory Builder)

Intervention Type: 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.

Placebo group

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

Group Type: PLACEBO_COMPARATOR

Placebo group

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Amway (China) R&D Center

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wenan Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Jiao Tong University School of Medicine

Locations

Kangrong Clinic

Jinhua, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wenan Wang, MD

Role: CONTACT

13611641232@163.com

13611641232

Facility Contacts

Charlie Zhang, MD

Role: primary

charlie.zhang@sprimmedical.com

+8613901981272

Other Identifiers

IS20220006RD

Identifier Type: -

Identifier Source: org_study_id