search
Back to results

Study of Metabolic Homeostasis in Chinese

Primary Purpose

Healthy, Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Standard mixed macronutrients tolerance test
Sponsored by
Chinese Academy of Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy focused on measuring Metabolic health, MMTT, Resilience

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • healthy subjects: age 20-70 BMI ≥ 18.5
  • Mets subjects:

age 30-70 BMI ≥ 18.5 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. Diabetes or a history of medical or surgical events that may significantly affect the study outcome, including medication for diabetes, cholesterol lowering medication
  2. Pregnancy or lactation
  3. Gastrointestinal diseases
  4. Severe renal disease or liver disease
  5. Severe pituitary or thyroid diseases;
  6. Mental disorders or current use of antidepressants
  7. Cardiovascular disease, stroke or phase three hypertension
  8. Cancer or receiving radiotherapy and chemotherapy within 5 years
  9. History of drug or alcohol abuse or other substance abuse (Alcohol abuse is defined as more than 40 g/day of alcohol for woman, and more than 80g/day for man)
  10. Suffering from AIDS, hepatitis A, hepatitis B and other infectious diseases
  11. Attempting to changing bodyweight
  12. Physical disability.

Sites / Locations

  • Longhua Hospital Shanghai University of Traditional Chinese Medicine

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Standardized mixed macronutrients tolerance test

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
November 7, 2019
Last Updated
September 1, 2023
Sponsor
Chinese Academy of Sciences
Collaborators
Shanghai University of Traditional Chinese Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT04173728
Brief Title
Study of Metabolic Homeostasis in Chinese
Official Title
Study of Metabolic Homeostasis in Chinese
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
December 27, 2019 (Actual)
Primary Completion Date
February 23, 2021 (Actual)
Study Completion Date
February 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Sciences
Collaborators
Shanghai University of Traditional Chinese Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Metabolic Syndrome
Keywords
Metabolic health, MMTT, Resilience

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
111 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standardized mixed macronutrients tolerance test
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Standard mixed macronutrients tolerance test
Intervention Description
Consumption a standard mixture containing 75g glucose, 60g fat and 20 protein.
Primary Outcome Measure Information:
Title
Health state map (HSM)
Description
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).
Time Frame
fasting (t = 0 min), postprandial (t = 30, 60, 120, 180, 240 min)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xu Lin, PhD
Organizational Affiliation
Shanghai Institute of Nutrition and Health, Chinese Acadamy of Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Longhua Hospital Shanghai University of Traditional Chinese Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200031
Country
China

12. IPD Sharing Statement

Learn more about this trial

Study of Metabolic Homeostasis in Chinese

We'll reach out to this number within 24 hrs