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NCT Number: NCT07161557

Evaluating 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?

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.

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Key information

Conditions

Metabolic Abnormality Metabolic Diseases Metabolic Disorders Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai MCC Hospital

Shanghai, Shanghai Municipality, 201900, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

No Intervention: Observational Cohort

Other

No intervention involved, participants will fill out some questionnaires and blood samples will drawn for test and analysis.

Primary outcomes

  1. 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

Secondary outcomes

  1. SBP

    Time frame: day 1

    SBP(Systolic Blood Pressure), ideally <120 mmHg or still normal if less than 130mmHg

  2. DBP

    Time frame: day 1

    BDP(Diastolic Blood Pressure), ideally <80 mmHg, or still normal if less than 89 mmHg

  3. Blood test - LDL-C

    Time frame: day 1

    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;

  4. Blood test - HDL-C

    Time frame: day 1

    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;

  5. Blood test - TG

    Time frame: day 1

    TG (Triglyceride) concentration level in the blood sample test : normal range 0~1.7 mmol/L, higher than 1.7mmol/L is abnormal

  6. Blood test - TC

    Time frame: day 1

    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.

  7. Blood test - FBG

    Time frame: day 1

    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.

  8. BMI

    Time frame: day 1

    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.

  9. Waist Circumference

    Time frame: day 1

    waist circumference measured in cm (centimeter)

  10. Uric Acid Level

    Time frame: day 1

    uric acid level in μmol/L, the normal range for adult male：149～416μmol/L, adult female：89～357μmol/L

Study contacts

Contact information is provided by the study sponsor or research team.

Charlie Zhang, MD

CONTACT

[email protected]

+8613901981272

Sponsors and collaborators

Lead sponsor

Amway (China) R&D Center

Industry

Registry information

Official study title

An Open Observational Study to Evaluate Metabolic Health in People Aged 18 to 60 by Nutrilite Metabolic Health Index

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 8, 2025
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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