Clinical trial NCT05591885: Nutrilite Memory Builder on the Improvement of Cognitive Function
Official title: The Effect of Nutrilite Memory Builder on the Improvement of Cognitive Function: A Randomized Controlled Trial(RCT)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cognitive Function
Keywords: MMSE
MoCA
WMS-R
Cognitrax Test
Lead sponsor: Amway (China) R&D Center
Sponsor class: INDUSTRY
First posted: 2022-10-24
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Mini-Mental State Examination
timeFrame: endpoint( day 90)
measure: Wechsler Memory Scale RC
timeFrame: endpoint( day 90)
Secondary outcomes:
measure: Quality of Life Scale
timeFrame: baseline(day 0)/interim ( day 45)/endpoint( day 90)
measure: Activities of Daily Living Scale
timeFrame: baseline(day 0)/interim ( day 45)/endpoint( day 90)
measure: Verbal Memory Test of Cognitrax Test
timeFrame: baseline(day 0)/interim ( day 45)/endpoint( day 90)
measure: Finger Tapping Test of Cognitrax Test
timeFrame: baseline(day 0)/interim ( day 45)/endpoint( day 90)
measure: Symbol Digit Coding Test of Cognitrax Test
timeFrame: baseline(day 0)/interim ( day 45)/endpoint( day 90)
measure: Stroop Test of Cognitrax Test
timeFrame: baseline(day 0)/interim ( day 45)/endpoint( day 90)
measure: Shifting Attention Test of Cognitrax Test
timeFrame: baseline(day 0)/interim ( day 45)/endpoint( day 90)
measure: Continuous Performance Test of Cognitrax Test
timeFrame: baseline(day 0)/interim ( day 45)/endpoint( day 90)
measure: Four-part Continuous Performance Test of Cognitrax Test
timeFrame: baseline(day 0)/interim ( day 45)/endpoint( day 90)
measure: Montreal Cognitive Assessment;
timeFrame: baseline(day 0)/interim ( day 45)/endpoint( day 90)
measure: 72-hrs Food Recall
timeFrame: baseline(day 0)/interim ( day 45)/endpoint( day 90)
measure: Sport Frequency Questionnaire
timeFrame: baseline(day 0)/interim ( day 45)/endpoint( day 90)
measure: Blood
timeFrame: baseline(day 0)/endpoint( day 90)
measure: Urine
timeFrame: baseline(day 0)/endpoint( day 90)
Other outcomes:
Locations:
city: Jinhua
country: China
facility: Kangrong Clinic
state: Zhejiang
Study officials:
affiliation: Shanghai Jiao Tong University School of Medicine
name: Wenan Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: