Study of Metabolic Homeostasis in Chinese

September 1, 2023 updated by: Xu Lin, Chinese Academy of Sciences
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
111

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
fasting (t = 0 min), postprandial (t = 30, 60, 120, 180, 240 min)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
glucagon-like peptide-1
Time Frame: 4 hours
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
Time Frame: 4 hours
Values at fasting and postprandial 0.5, 1, 2, 3, 4h and the change curve will be measured and reported
4 hours
glucagon
Time Frame: 4 hours
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Serum E-selectin concentration
Time Frame: 4 hours
Concentration of serum E-selectin at fasting and postprandial 0.5, 1, 2, 3, 4h will be measured
4 hours
Serum P-selectin concentration
Time Frame: 4 hours
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
Time Frame: 4 hours
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
Time Frame: 4 hours
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
Time Frame: 4 hours
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
Time Frame: 4 hours
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
Time Frame: 4 hours
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
Time Frame: 4 hours
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
Time Frame: 4 hours
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
Time Frame: 4 hours
Metabonomics will be measured by liquid chromatograph-mass spectrometer, metabolic pathway analysis results will be reported.
4 hours
Single nucleotide polymorphism (SNPs)
Time Frame: baseline
Mutations at specific sites will be detected by gene chip。
baseline
Gut microbiota 16S rDNA sequencing
Time Frame: baseline
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese Academy of Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Shanghai University of Traditional Chinese Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Xu Lin, PhD, Shanghai Institute of Nutrition and Health, Chinese Acadamy of Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 27, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 23, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 23, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 7, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 22, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 6, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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