Study of Metabolic Homeostasis in Chinese

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Metabolic Syndrome
• Intervention / Treatment: Other: Standard mixed macronutrients tolerance test

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.

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200031
      • Longhua Hospital Shanghai University of Traditional Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Standardized mixed macronutrients tolerance test; Subjects with different age and BMI will be included. 1) 20 subjects aged 20-29 years with normal body weight (18.5 ≤BMI<24kg/m2); 2) 40 20 subjects aged 30-70 49 years with normal body weight (18.5 ≤ BMI<24kg/m2); 3) 40 20 subjects aged 30-70 49 years with overweight or obesity (BMI<24kg/m2).); 4) 20 subjects aged 50-70 years with normal body weight (18.5 ≤ BMI<24kg/m2); 5) 20 subjects aged 30-49 years with overweight or obesity (BMI<24kg/m2); 6) 20 subjects aged 30-70 years with MetS.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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-α), and targeted metabolites (such as amino acids, acylcarnitines).	fasting (t = 0 min), postprandial (t = 30, 60, 120, 180, 240 min)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
glucagon-like peptide-1	Values at fasting and postprandial 0.5, 1, 2, 3, 4h and the change curve will be measured and reported	4 hours
gastric inhibitory peptide	Values at fasting and postprandial 0.5, 1, 2, 3, 4h and the change curve will be measured and reported	4 hours
glucagon	Values at fasting and postprandial 0.5, 1, 2, 3, 4h and the change curve will be measured and reported	4 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum E-selectin concentration	Concentration of serum E-selectin at fasting and postprandial 0.5, 1, 2, 3, 4h will be measured	4 hours
Serum P-selectin concentration	Concentration of serum P-selectin at fasting and postprandial 0.5, 1, 2, 3, 4h will be measured	4 hours
Serum vascular cell adhesion molecule-1(VCAM-1) concentration	Concentration of serum VCAM-1 at fasting and postprandial 0.5, 1, 2, 3, 4h will be measured	4 hours
Serum intercellular adhesion molecule-1 (ICAM-1) concentration	Concentration of serum ICAM-1 at fasting and postprandial 0.5, 1, 2, 3, 4h will be measured	4 hours
Serum Amyloid A1(SAA1) concentration	Concentration of serum SAA1 at fasting and postprandial 0.5, 1, 2, 3, 4h will be measured	4 hours
Serum Tumor Necrosis Factor-α (TNF-α) concentration	Concentration of serum TNF-α at fasting and postprandial 0.5, 1, 2, 3, 4h will be measured	4 hours
Serum interleukin-10(IL-10) concentration	Concentration of serum IL-10 at fasting and postprandial 0.5, 1, 2, 3, 4h will be measured	4 hours
Serum interleukin-1b(IL-1b) concentration	Concentration of serum IL-1b at fasting and postprandial 0.5, 1, 2, 3, 4h will be measured	4 hours
Serum C-reactive protein(CRP) concentration	CRP are proteins that rises sharply in plasma when the body is infected or tissue damaged, CRP concentration in serum at fasting and postprandial 0.5, 1, 2, 3, 4h and the change curve will be measured	4 hours
metabolomics	Metabonomics will be measured by liquid chromatograph-mass spectrometer, metabolic pathway analysis results will be reported.	4 hours
Single nucleotide polymorphism (SNPs)	Mutations at specific sites will be detected by gene chip。	baseline
Gut microbiota 16S rDNA sequencing	Gut microbiota 16S rDNA will be sequenced, community composition will be analysed and the community composition differences between individuals will be reported.	baseline

Collaborators and Investigators

• Sponsor: Chinese Academy of Sciences
• Collaborators: Shanghai University of Traditional Chinese Medicine
• Investigators: Principal Investigator: Xu Lin, PhD, Shanghai Institute of Nutrition and Health, Chinese Acadamy of Sciences

Study record dates

Study Major Dates

• Study Start (Actual): December 27, 2019
• Primary Completion (Actual): February 23, 2021
• Study Completion (Actual): February 23, 2021

Study Registration Dates

• First Submitted: November 7, 2019
• First Submitted That Met QC Criteria: November 20, 2019
• First Posted (Actual): November 22, 2019

Study Record Updates

• Last Update Posted (Actual): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 1, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Resilience; Metabolic health; MMTT
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Metabolic Syndrome
• Other Study ID Numbers: CAS-MH-201911

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No