The Effect of Nutrilite Memory Builder on the Improvement of Cognitive Function: A Randomized Controlled Trial(RCT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Wechsler Memory Scale RC
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Study product gruop
Nutrilite Memory Builder Ingredients (Cistanche deserticola extract, Ginkgo biloba extract, glucose, microcrystalline cellulose, corn starch, etc.) 60 Tablets / bottle
干预措施: Study product group (Nutrilite Memory Builder) (Dietary Supplement)
Placebo group
Ingredients (glucose, microcrystalline cellulose, corn starch, caramel pigment, etc.) 60 Tablets / bottle
干预措施: Placebo group (Dietary Supplement)
结局指标
主要结局
Wechsler Memory Scale RC
时间窗: endpoint( day 90)
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.
Mini-Mental State Examination
时间窗: endpoint( day 90)
Change of mental status after 90-days product intervention
次要结局
- Shifting Attention 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))
- Four-part Continuous Performance Test of Cognitrax Test(baseline(day 0)/interim ( day 45)/endpoint( day 90))
- Urine(baseline(day 0)/endpoint( day 90))
- Sport Frequency Questionnaire(baseline(day 0)/interim ( day 45)/endpoint( day 90))
- 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))
- Stroop Test of Cognitrax Test(baseline(day 0)/interim ( day 45)/endpoint( day 90))
- Continuous Performance Test of Cognitrax Test(baseline(day 0)/interim ( day 45)/endpoint( day 90))
- 72-hrs Food Recall(baseline(day 0)/interim ( day 45)/endpoint( day 90))
- Blood(baseline(day 0)/endpoint( day 90))
- Finger Tapping Test of Cognitrax Test(baseline(day 0)/interim ( day 45)/endpoint( day 90))
- Montreal Cognitive Assessment;(baseline(day 0)/interim ( day 45)/endpoint( day 90))