Study of Metabolic Homeostasis in Chinese

NCT ID: NCT04173728

Last Updated: 2023-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-27
• Study Completion Date: 2021-02-23

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.

Conditions

Healthy; Metabolic Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Standard mixed macronutrients tolerance test

Intervention Type: OTHER

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

Interventions

Standard mixed macronutrients tolerance test

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

Intervention Type: OTHER

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)

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai University of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Chinese Academy of Sciences

OTHER_GOV

Sponsor Role: lead

Responsible Party

Xu Lin

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xu Lin, PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Institute of Nutrition and Health, Chinese Acadamy of Sciences

Locations

Longhua Hospital Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

CAS-MH-201911

Identifier Type: -

Identifier Source: org_study_id