Cognitive FunctionNCT05591885
Nutrilite Memory Builder on the Improvement of Cognitive Function
A study testing Study product group (Nutrilite Memory Builder) in people with Cognitive Function, run by Amway (China) R&D Center at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Function
- What is being tested?
- Study product group (Nutrilite Memory Builder)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 24 Oct 2022to 31 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Kangrong Clinic
Jinhua, Zhejiang, 321041
Charlie Zhang, MD, +8613901981272, charlie.zhang@sprimmedical.com
Wenan Wang, Professor
About this study
Official title: 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.
Read the 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
- Being tested
- Study product group (Nutrilite Memory Builder), Placebo group
- Keywords
- MMSE, MoCA, WMS-R, Cognitrax Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Placebo groupDietary supplement
During study intervention, subjects are required to take the randomly assigned placebo following the instructions.Take one tablet twice daily with meals.
| Study group | Role | What they receive |
|---|---|---|
| Study product gruop | Experimental | Nutrilite Memory Builder Ingredients (Cistanche deserticola extract, Ginkgo biloba extract, glucose, microcrystalline cellulose, corn starch, etc.) 60 Tablets / bottle Receives: Dietary Supplement: Study product group (Nutrilite Memory Builder) |
| Placebo group | Placebo comparator | Ingredients (glucose, microcrystalline cellulose, corn starch, caramel pigment, etc.) 60 Tablets / bottle Receives: Dietary Supplement: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-Mental State Examination
Change of mental status after 90-days product intervention
Measured: 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.
Measured: endpoint( day 90)
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline(day 0)/interim ( day 45)/endpoint( day 90)
Montreal Cognitive Assessment;
Test Cognitive Ability
Measured: baseline(day 0)/interim ( day 45)/endpoint( day 90)
72-hrs Food Recall
72-hours food recall of subjects
Measured: baseline(day 0)/interim ( day 45)/endpoint( day 90)
Sport Frequency Questionnaire
Record the exercise frequency and duration within one week, without any score.
Measured: baseline(day 0)/interim ( day 45)/endpoint( day 90)
Blood
blood routine test （red blood cell count, white blood cell count, platelet count，hemoglobin）
Measured: baseline(day 0)/endpoint( day 90)
Urine
Urine routine test（Leukocyte, Urine Protein, Ketone Body）
Measured: baseline(day 0)/endpoint( day 90)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start24 Oct 2022
- Primary completion31 May 2023 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amway (China) R&D Center
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wenan Wang, MD, Principal investigator, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05591885
- Sponsor's protocol ID
- IS20220006RD
- Status last verified
- Apr 2023
- First submitted
- 12 Oct 2022
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nutrilite Memory Builder on the Improvement of Cognitive Function: A Randomized Controlled Trial(RCT)
- ClinicalTrials.gov ID
- NCT05591885
- Acronym / sponsor ID
- IS20220006RD
- Conditions
- Cognitive Function
- Keywords
- MMSE, MoCA, WMS-R, Cognitrax Test
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Amway (China) R&D CenterIndustry (pharma, biotech, devices)
- Study start
- 24 Oct 2022 (actual)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 24 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Study product gruop | Experimental | Dietary Supplement: Study product group (Nutrilite Memory Builder)Nutrilite Memory Builder Ingredients (Cistanche deserticola extract, Ginkgo biloba extract, glucose, microcrystalline cellulose, corn starch, etc.) 60 Tablets / bottle |
| Placebo group | Placebo comparator | Dietary Supplement: Placebo groupIngredients (glucose, microcrystalline cellulose, corn starch, caramel pigment, etc.) 60 Tablets / bottle |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | Study product gruop |
| Placebo groupDuring study intervention, subjects are required to take the randomly assigned placebo following the instructions.Take one tablet twice daily with meals. | Dietary supplement | Placebo group |
Primary outcome
Mini-Mental State Examination
Time frame: endpoint( day 90)
Change of mental status after 90-days product intervention
Wechsler Memory Scale RC
Time frame: 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.
14 secondary outcomes
Quality of Life Scale
Time frame: baseline(day 0)/interim ( day 45)/endpoint( day 90)
Activities of Daily Living Scale
Time frame: baseline(day 0)/interim ( day 45)/endpoint( day 90)
Verbal Memory Test of Cognitrax Test
Time frame: baseline(day 0)/interim ( day 45)/endpoint( day 90)
Finger Tapping Test of Cognitrax Test
Time frame: baseline(day 0)/interim ( day 45)/endpoint( day 90)
Symbol Digit Coding Test of Cognitrax Test
Time frame: baseline(day 0)/interim ( day 45)/endpoint( day 90)
Stroop Test of Cognitrax Test
Time frame: baseline(day 0)/interim ( day 45)/endpoint( day 90)
Shifting Attention Test of Cognitrax Test
Time frame: baseline(day 0)/interim ( day 45)/endpoint( day 90)
Continuous Performance Test of Cognitrax Test
Time frame: baseline(day 0)/interim ( day 45)/endpoint( day 90)
Four-part Continuous Performance Test of Cognitrax Test
Time frame: baseline(day 0)/interim ( day 45)/endpoint( day 90)
Montreal Cognitive Assessment;
Time frame: baseline(day 0)/interim ( day 45)/endpoint( day 90)
72-hrs Food Recall
Time frame: baseline(day 0)/interim ( day 45)/endpoint( day 90)
Sport Frequency Questionnaire
Time frame: baseline(day 0)/interim ( day 45)/endpoint( day 90)
Blood
Time frame: baseline(day 0)/endpoint( day 90)
Urine
Time frame: baseline(day 0)/endpoint( day 90)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wenan Wang, MD principal investigator
Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study product group (Nutrilite Memory Builder) in people with Cognitive Function, run by Amway (China) R&D Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wenan Wang, MD (13611641232, 13611641232@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini-Mental State Examination (time frame: endpoint( day 90)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2023.