Clinical Trials Directory

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

TypeNameDescription
OTHERStandard mixed macronutrients tolerance testConsumption 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.