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NCT Number: NCT04173728

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.

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Longhua Hospital Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 200031, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

  • Waist circumference ≥ 90 cm (men), ≥ 80 cm (women).
  • Total triglyceride ≥ 1.7 mmol/L.
  • HDL-c <1.03 mmol/L in men, <1.3 mmol/L in women.
  • Systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmHg.
  • Fasting plasma glucose ≥ 5.6 mmol/L.

Exclusion criteria

  • clinically diagnosed diabetes or use of anti-diabetic medications;
  • clinically diagnosed cardiovascular, kidney, liver, pituitary, alimentary tract, and thyroid diseases, cancer(s), or mental illnesses;
  • pregnancy or lactation;
  • having gastrointestinal surgery within 1 year, excepting appendicitis or hernia;
  • current use of antidepressant(s);
  • alcohol consumption > 40 g/d or other substance abuse;
  • severe diarrhea (watery stools ≥ 3 times/day ≥ 3 days or longer) in previous 3 months;
  • participating any other studies within previous 3 months.

Treatment and study plan

Standard mixed macronutrients tolerance test

Other

Consumption a standard mixture containing 75g glucose, 60g fat and 20 protein.

Primary outcomes

  1. Health state map (HSM)

    Time frame: fasting (t = 0 min), postprandial (t = 30, 60, 120, 180, 240 min)

    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).

Sponsors and collaborators

Lead sponsor

Chinese Academy of Sciences

Other Gov

Collaborators

  • Shanghai University of Traditional Chinese Medicine

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 22, 2019
Registry last updated
Sep 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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