Evaluating Metabolic Health in People Aged 18 to 60 by Nutrilite Metabolic Health Index

Официальное название

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

Обзор

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.

Вмешательства

• Другое No Intervention: Observational Cohort
  No intervention involved, participants will fill out some questionnaires and blood samples will drawn for test and analysis.

Первичные конечные точки

• Nutrilite Metabolic Health Index [Срок оценки: day 1]

Вторичные конечные точки (10)

• SBP [Срок оценки: day 1]
• DBP [Срок оценки: day 1]
• Blood test - LDL-C [Срок оценки: day 1]
• Blood test - HDL-C [Срок оценки: day 1]
• Blood test - TG [Срок оценки: day 1]
• Blood test - TC [Срок оценки: day 1]
• Blood test - FBG [Срок оценки: day 1]
• BMI [Срок оценки: day 1]
• Waist Circumference [Срок оценки: day 1]
• Uric Acid Level [Срок оценки: day 1]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Китай · 1 центр

• Shanghai MCC Hospital — Шанхай

Идентификаторы

NCT: NCT07161557 · 24-RD-10-AY-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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