Metabolic AbnormalityNCT07161557
Evaluating Metabolic Health in People Aged 18 to 60 by Nutrilite Metabolic Health Index
An observational study of Metabolic Abnormality and Metabolic Disorders, run by Amway (China) R&D Center at 1 site in China.
Trial summary
The goal of this observational study is to evaluate Metabolic Health by fit analysis between calculated Nutrilite Metabolic Health Index and the result of Metabolomics analysis from blood plasma samples in healthy adult participants aged between 18 and 60 years. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Abnormality, Metabolic Disorders
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2025to 10 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Male and female participants, aged 18 to 60, regardless of gender;
Who may be able to join
- Male and female volunteers, aged 18 to 60, regardless of gender;
- Not participating in other interventional clinical studies;
- Have a good understanding of the nature, purpose, benefits obtained, and possible risks and side effects of the study;
- Willing to comply with all trial requirements and procedures;
- Sign the informed consent form.
Who cannot join
- In the treatment of gastrointestinal symptoms;
- Those who are lactose intolerant, allergic to fish and their products;
- Current suffering from other organic diseases affecting bowel function, such as history of gastrointestinal resection, colon or rectal cancer, inflammatory bowel disease, diabetes, hyperthyroidism or hypothyroidism, Hirschsprung's disease, scleroderma, anorexia nervosa, etc.;
- Diet control, exercise enhancement, or taking medications that control weight or affect appetite in the past 3 months;
- Volunteers have any of the following medical history or have been clinically diagnosed with the following diseases that may affect the evaluation of the test results: obvious gastrointestinal disorders, liver, kidney, endocrine, blood, respiratory and cardiovascular diseases;
- Current or past abuse of alcohol or other illicit drugs, supplements, or OTC prescriptions 3 / 11 Research content Collection of biological samples or information data Evaluation indicators Drugs may cause intestinal dysfunction or affect the evaluation of trial effects;
- Frequent use of drugs that may affect gastrointestinal function or immune system according to the investigator's judgment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Open Observational Study to Evaluate Metabolic Health in People Aged 18 to 60 by Nutrilite Metabolic Health Index
The goal of this observational study is to evaluate Metabolic Health by fit analysis between calculated Nutrilite Metabolic Health Index and the result of Metabolomics analysis from blood plasma samples in healthy adult participants aged between 18 and 60 years. The main question it aims to answer:
- Does the Nutrilite Metabolic Health Index fit well with the result of Metabolomics analysis from blood plasma samples?
Read more
200 eligible participants will be enrolled in a single center, one site visit will be made to finish a health questionnaire, a lifestyle questionnaire, a routine physical checkup. Blood samples will be collected for routine blood test (blood sugar, total triglycerides, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, uric acid), and for Metabolomics testing.
Researchers will calculate the Nutrilite Metabolic Health Index based on participant data, and do the fit analysis against the result from Metabolomics analysis.
- Conditions
- Metabolic Abnormality, Metabolic Disorders
- Being tested
- No Intervention: Observational Cohort
- Keywords
- Diet2Me, Nutrilite Metabolic Health Index, Metabolic health omics model, Metabolomics testing
- Medical subject headings
- Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
No intervention involved, participants will fill out some questionnaires and blood samples will drawn for test and analysis.
| Study group | Role | What they receive |
|---|---|---|
| All participants | All participants enrolled will be asked to fill out the questionnaires, have physical checkup, and take blood samples, no interventions involved. Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutrilite Metabolic Health Index
Nutrilite Metabolic Health Index incorporates seven core biochemical parameters (see details in Secondary Outcome Measures): body mass index (BMI), waist circumference, fasting blood glucose (FBG) level, blood lipid profile (total cholesterol (TC), total triglycerides(TG), Low-Density Lipoprotein Cholesterol (LDL), High-Density Lipoprotein Cholesterol (HDL), blood pressure (Systolic Blood Pressure(SBP), and Diastolic Blood Pressure (BDP)), uric acid level, and history of fatty liver disease; along with four lifestyle and hereditary factors: smoking, alcohol consumption, age, and family history of metabolic diseases.
After weighted calculation, the index score ranges from 0 to 100, divided into four grades:
Excellent: 85-100 Moderate: 60-84 Poor: 40-59 Severe: 0-39
Measured: day 1
Secondary outcomes (10)
SBP
SBP(Systolic Blood Pressure), ideally <120 mmHg or still normal if less than 130mmHg
Measured: day 1
DBP
BDP(Diastolic Blood Pressure), ideally <80 mmHg, or still normal if less than 89 mmHg
Measured: day 1
Blood test - LDL-C
LDL-C(Low-Density Lipoprotein Cholesterol) concentration level in the blood sample test: normal range 0-3.1mmol/L, higher than 3.1 mmol/L is abnormal;
Measured: day 1
Blood test - HDL-C
HDL-C(High-Density Lipoprotein Cholesterol) concentration level in the blood sample test: normal range 1.04~1.55 mmol/L, lower than 1.04 or higher than 1.55 mmol/L is abnormal;
Measured: day 1
Blood test - TG
TG (Triglyceride) concentration level in the blood sample test : normal range 0~1.7 mmol/L, higher than 1.7mmol/L is abnormal
Measured: day 1
Blood test - TC
TC (Total Cholesterol) concentration level in the blood sample test: normal range 3-5.2 mmol/L; higher than 5.2 mmol/L is abnormal.
Measured: day 1
Blood test - FBG
FBG(Fasting Blood Glucose) concentration level in the blood sample test: normal range 4.-5.5mmol/L, higher than 5.5 mmol/L is abnormal.
Measured: day 1
BMI
BMI (Body Mass Index), BMI is calculated by weight/height^2, where weight measured with unit kg, and height with unit meter, and weight and height will be combined to report BMI in kg/m^2.
Measured: day 1
Waist Circumference
waist circumference measured in cm (centimeter)
Measured: day 1
Uric Acid Level
uric acid level in μmol/L, the normal range for adult male：149～416μmol/L, adult female：89～357μmol/L
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start9 Oct 2025 (estimated)
- Primary completion10 Apr 2026 (estimated)
- Study completion10 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic AbnormalityStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amway (China) R&D Center
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zheng Qu, Principal investigator, Shanghai MCC Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07161557
- Sponsor's protocol ID
- 24-RD-10-AY-001
- Status last verified
- Sep 2025
- First submitted
- 28 Aug 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Observational Study to Evaluate Metabolic Health in People Aged 18 to 60 by Nutrilite Metabolic Health Index
- ClinicalTrials.gov ID
- NCT07161557
- Acronym / sponsor ID
- 24-RD-10-AY-001
- Conditions
- Metabolic Abnormality, Metabolic Disorders
- Keywords
- Diet2Me, Nutrilite Metabolic Health Index, Metabolic health omics model, Metabolomics testing
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Amway (China) R&D CenterIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2025 (estimated)
- Primary completion
- 10 Apr 2026 (estimated)
- Study completion
- 10 May 2026 (estimated)
- First posted
- 8 Sep 2025 (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.
The goal of this observational study is to evaluate Metabolic Health by fit analysis between calculated Nutrilite Metabolic Health Index and the result of Metabolomics analysis from blood plasma samples in healthy adult participants aged between 18 and 60 years. The main question it aims to answer:
- Does the Nutrilite Metabolic Health Index fit well with the result of Metabolomics analysis from blood plasma samples?
200 eligible participants will be enrolled in a single center, one site visit will be made to finish a health questionnaire, a lifestyle questionnaire, a routine physical checkup. Blood samples will be collected for routine blood test (blood sugar, total triglycerides, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, uric acid), and for Metabolomics testing.
Researchers will calculate the Nutrilite Metabolic Health Index based on participant data, and do the fit analysis against the result from Metabolomics analysis.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | – | Other: No Intervention: Observational CohortAll participants enrolled will be asked to fill out the questionnaires, have physical checkup, and take blood samples, no interventions involved. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Male and female participants, aged 18 to 60, regardless of gender;
Key inclusion criteria (5 listed)
- Male and female volunteers, aged 18 to 60, regardless of gender;
- Not participating in other interventional clinical studies;
- Have a good understanding of the nature, purpose, benefits obtained, and possible risks and side effects of the study;
- Willing to comply with all trial requirements and procedures;
- Sign the informed consent form.
Key exclusion criteria (7 listed)
- In the treatment of gastrointestinal symptoms;
- Those who are lactose intolerant, allergic to fish and their products;
- Current suffering from other organic diseases affecting bowel function, such as history of gastrointestinal resection, colon or rectal cancer, inflammatory bowel disease, diabetes, hyperthyroidism or hypothyroidism, Hirschsprung's disease, scleroderma, anorexia nervosa, etc.;
- Diet control, exercise enhancement, or taking medications that control weight or affect appetite in the past 3 months;
- Volunteers have any of the following medical history or have been clinically diagnosed with the following diseases that may affect the evaluation of the test results: obvious gastrointestinal disorders, liver, kidney, endocrine, blood, respiratory and cardiovascular diseases;
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 |
|---|---|---|
| No Intervention: Observational CohortNo intervention involved, participants will fill out some questionnaires and blood samples will drawn for test and analysis. | Other | All participants |
Primary outcome
Nutrilite Metabolic Health Index
Time frame: day 1
Nutrilite Metabolic Health Index incorporates seven core biochemical parameters (see details in Secondary Outcome Measures): body mass index (BMI), waist circumference, fasting blood glucose (FBG) level, blood lipid profile (total cholesterol (TC), total triglycerides(TG), Low-Density Lipoprotein Cholesterol (LDL), High-Density Lipoprotein Cholesterol (HDL), blood pressure (Systolic Blood Pressure(SBP), and Diastolic Blood Pressure (BDP)), uric acid level, and history of fatty liver disease; along with four lifestyle and hereditary factors: smoking, alcohol consumption, age, and family history of metabolic diseases. After weighted calculation, the index score ranges from 0 to 100, divided into four grades: Excellent: 85-100 Moderate: 60-84 Poor: 40-59 Severe: 0-39
10 secondary outcomes
SBP
Time frame: day 1
DBP
Time frame: day 1
Blood test - LDL-C
Time frame: day 1
Blood test - HDL-C
Time frame: day 1
Blood test - TG
Time frame: day 1
Blood test - TC
Time frame: day 1
Blood test - FBG
Time frame: day 1
BMI
Time frame: day 1
Waist Circumference
Time frame: day 1
Uric Acid Level
Time frame: day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
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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.
Zheng Qu principal investigator
Shanghai MCC Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Abnormality and Metabolic Disorders, 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 7 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: opening soon, as of the sponsor's last update on 12 Sep 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charlie Zhang, MD (+8613901981272, charlie.zhang@raisonbiotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutrilite Metabolic Health Index (time frame: day 1). 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 12 Sep 2025.