An Open Observational Study to Evaluate Metabolic Health in People Aged 18 to 60 by Nutrilite Metabolic Health Index
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Nutrilite Metabolic Health Index
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Nutrilite Metabolic Health Index
时间窗: 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
次要结局
- SBP(day 1)
- BMI(day 1)
- Waist Circumference(day 1)
- Uric Acid Level(day 1)
- DBP(day 1)
- Blood test - LDL-C(day 1)
- Blood test - HDL-C(day 1)
- Blood test - TG(day 1)
- Blood test - TC(day 1)
- Blood test - FBG(day 1)