Trials / Completed
CompletedNCT04173728
Study of Metabolic Homeostasis in Chinese
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 111 (actual)
- Sponsor
- Chinese Academy of Sciences · Other Government
- Sex
- All
- Age
- 20 Years – 70 Years
- Healthy volunteers
- Accepted
Summary
In this open-label, acute intervention study, we will recruit 120 sex-matched participants aged 20-70 years (100 normal or overweight/obese subjects and 20 Mets subjects). They will be assigned to one of the six groups according to age, BMI and with and without MetS and have a standardized mixed macronutrient tolerance test (MMTT) by orally administered a 400-ml beverage (75g glucose, 60g lipid, and 20g protein). Fasting and postprandial blood, and urine and fecal samples will be collected. The primary aim is to establish a more comprehensive system to quantify different aspects of metabolic health based on fasting and postprandial data. The study protocol has been approved by the Ethics Committee of Shanghai Institutes for Biological Sciences.
Detailed description
The recruited 120 subjects (60 men and 60 women aged 20-70 years) will be recruited according to the followings: 1) individuals aged 20-29 years with normal weight (18.5 kg/m2 ≤ BMI \< 24 kg/m2); 2) individuals aged 30-49 years with normal weight; 3) individuals aged 30-49 years with overweight/obesity (BMI ≥ 24 kg/m2); 4) individuals aged 50-70 years with normal weight; 5) individuals aged 50-70 years with overweight/obesity; and 6) individuals aged 30-70 years with MetS. A standard questionnaire will be use to collect Information like lifestyle factors, nighttime sleep duration; anthropometric measurements will be performed. Blood samples will be collected via a catheter at fasting state (t = 0 min) and 5 successive time points post-MMTT (t = 30, 60, 120, 180 and 240 min). At t = 0 ,1 and 2 h, the fingertip blood will be collected as well. Body composition will be measured by dual energy x-ray absorptiometry (DXA). All these samples will be used to the assessment of blood chemistry, metabolomics, single nucleotide polymorphism (SNP), gut microbiota etc.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Standard mixed macronutrients tolerance test | Consumption a standard mixture containing 75g glucose, 60g fat and 20 protein. |
Timeline
- Start date
- 2019-12-27
- Primary completion
- 2021-02-23
- Completion
- 2021-02-23
- First posted
- 2019-11-22
- Last updated
- 2023-09-06
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04173728. Inclusion in this directory is not an endorsement.