Study of Metabolic Homeostasis in Chinese

Healthy Clinical Trial

Official title:

Study of Metabolic Homeostasis in Chinese

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04173728
• Other study ID #: CAS-MH-201911
• Status: Completed
• Phase: N/A
• Start date: December 27, 2019
• Est. completion date: February 23, 2021

Study information

• Verified date: August 2023
• Source: Chinese Academy of Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: February 23, 2021
• Est. primary completion date: February 23, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• healthy subjects: age 20-70 BMI = 18.5 kg/m2

• Mets subjects:

age 30-70 BMI = 18.5 kg/m2 and at least meet three of the following criterions(NCEP-ATPIII, for Asian Americans)

1. Waist circumference = 90 cm (men), = 80 cm (women).

2. Total triglyceride = 1.7 mmol/L.

3. HDL-c <1.03 mmol/L in men, <1.3 mmol/L in women.

4. Systolic blood pressure = 130 mmHg or diastolic blood pressure = 85 mmHg.

5. Fasting plasma glucose = 5.6 mmol/L.

Exclusion Criteria:

1. clinically diagnosed diabetes or use of anti-diabetic medications;

2. clinically diagnosed cardiovascular, kidney, liver, pituitary, alimentary tract, and thyroid diseases, cancer(s), or mental illnesses;

3. pregnancy or lactation;

4. having gastrointestinal surgery within 1 year, excepting appendicitis or hernia;

5. current use of antidepressant(s);

6. alcohol consumption > 40 g/d or other substance abuse;

7. severe diarrhea (watery stools = 3 times/day = 3 days or longer) in previous 3 months;

8. participating any other studies within previous 3 months.

Related Conditions & MeSH terms

• Healthy
• Metabolic Syndrome

Intervention

Other:
• Standard mixed macronutrients tolerance test
Consumption a standard mixture containing 75g glucose, 60g fat and 20 protein.

Locations

Country	Name	City	State
China	Longhua Hospital Shanghai University of Traditional Chinese Medicine	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Chinese Academy of Sciences	Shanghai University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health state map (HSM)	A two-dimensional system comprising "Health Phenotype Score" for fasting features and "Homeostatic Resilience Score" for post-MMTT features will be built. We want to investigate whether HSM is more informative than a one-dimensional model with fasting data and the Mixed-score model combining fasting and postprandial data. Features includes BMI, blood pressure, HbA1c, body compositions, glucose, insulin, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triacylglycerol, alanine aminotransferase, aspartate aminotransferase, gamma- glutamyl transpeptidase, C-reactive protein, free triiodothyronine, free thyroxine, thyroid stimulating hormone, gastric inhibitory polypeptide, glucagon-like peptide-1, adiponectin, leptin, intercellular cell adhesion molecule-1, vascular cell adhesion molecule-1, inflammatory factors (such as interleukin, -6, -8 and 1b, and tumor Necrosis Factor-a), and targeted metabolites (such as amino acids, acylcarnitines).	fasting (t = 0 min), postprandial (t = 30, 60, 120, 180, 240 min)