Study of Metabolic Homeostasis in Chinese
Study Details
Study Description
Brief Summary
This is a single-center, explorative, open-label study among 120 subjects(100 healthy, 20 with Mets) will be recruited. All the subjects are assigned to four groups based on combinations of age, BMI and Mets condition. All the subjects will be given a 400ml standard meal with a macronutrient composition of 75g glucose, 60 fat and 20g protein and fasting and multiple postprandial time points samples (blood, urine and feces) will be collected. The primary objects of this study is to explore the metabolic homeostasis healthy condition of Chinese people through the capacity of the response to the meal. The study' protocol has been approved by the Ethics Committee of Shanghai Institutes for Biological Sciences.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
In this study 120 subjects(60 males and 60 females, aged between 20 and 70 years) including100 healthy subjects and 20 Mets subjects will be recruited. The healthy subjects will assigned to three groups as followed: 1) 20 subjects aged 20-29 years with normal body weight (18.5 ≤BMI<24kg/m2); 2) 40 subjects aged 30-70 years with normal body weight (18.5 ≤ BMI<24kg/m2); 3) 40 subjects aged 30-70 years with overweight or obesity(BMI>24kg/m2). All the 20 Mets subjects aged between 30-70 years will be assigned to the fourth group. On study days before the first blood draw, a cannula was placed and blood samples were taken at t = 0 (fasting) and five time-points (t = 0.5, 1, 2, 3 and 4 h) after consumption of the standard meal. Subjects were not allowed to eat or drink until the last blood sampling, except from drinking water. 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 assesment of blood chemistry, metabolomics, single nucleotide polymorphism (SNP), gut microbiota and etc.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: young and normal weight 20 subjects aged 20-29 years with normal body weight(18.5≤BMI<24), male:female = 1:1 |
Dietary Supplement: Standard meal
Consumption a standard meal consisted of 75g glucose, 60g fat and 20 protein just for once.
|
| Experimental: normal weight 40 subjects aged 30-70 years with normal body weight(18.5≤BMI<24), male:female = 1:1 |
Dietary Supplement: Standard meal
Consumption a standard meal consisted of 75g glucose, 60g fat and 20 protein just for once.
|
| Experimental: overweight or obesity 40 subjects aged 30-70 years with overweight or obesity (BMI≥24), male:female = 1:1 |
Dietary Supplement: Standard meal
Consumption a standard meal consisted of 75g glucose, 60g fat and 20 protein just for once.
|
| Experimental: Mets 20 objects with Mets, male:female = 1:1 |
Dietary Supplement: Standard meal
Consumption a standard meal consisted of 75g glucose, 60g fat and 20 protein just for once.
|
Outcome Measures
Primary Outcome Measures
- Glucose [4 hours]
Values at fasting and postprandial 0.5, 1, 2, 3, 4h and the change curve will be measured and reported
- C-peptide [4 hours]
Values at fasting and postprandial 0.5, 1, 2, 3, 4h and the change curve will be measured and reported
- insulin [4 hours]
Values at fasting and postprandial 0.5, 1, 2, 3, 4h and the change curve will be measured and reported
- total cholesterol [4 hours]
Values at fasting and postprandial 0.5, 1, 2, 3, 4h and the change curve will be measured and reported
- HDL-cholesterol [4 hours]
Values at fasting and postprandial 0.5, 1, 2, 3, 4h and the change curve will be measured and reported
- LDL-cholesterol [4 hours]
Values at fasting and postprandial 0.5, 1, 2, 3, 4h and the change curve will be measured and reported
- triglycerides, [4 hours]
Values at fasting and postprandial 0.5, 1, 2, 3, 4h and the change curve will be measured and reported
- free faty acid [4 hours]
Values at fasting and postprandial 0.5, 1, 2, 3, 4h and the change curve will be measured and reported
- Aspartate transaminase [4 hours]
Values at fasting and postprandial 0.5, 1, 2, 3, 4h and the change curve will be measured and reported
- alanine aminotransferase [4 hours]
Values at fasting and postprandial 0.5, 1, 2, 3, 4h and the change curve will be measured and reported
- γ-glutamyl transpeptidase [4 hours]
Values at fasting and postprandial 0.5, 1, 2, 3, 4h and the change curve will be measured and reported
Secondary Outcome Measures
- glucagon-like peptide-1 [4 hours]
Values at fasting and postprandial 0.5, 1, 2, 3, 4h and the change curve will be measured and reported
- gastric inhibitory peptide [4 hours]
Values at fasting and postprandial 0.5, 1, 2, 3, 4h and the change curve will be measured and reported
- glucagon [4 hours]
Values at fasting and postprandial 0.5, 1, 2, 3, 4h and the change curve will be measured and reported
Other Outcome Measures
- Serum E-selectin concentration [4 hours]
Concentration of serum E-selectin at fasting and postprandial 0.5, 1, 2, 3, 4h will be measured
- Serum P-selectin concentration [4 hours]
Concentration of serum P-selectin at fasting and postprandial 0.5, 1, 2, 3, 4h will be measured
- Serum vascular cell adhesion molecule-1(VCAM-1) concentration [4 hours]
Concentration of serum VCAM-1 at fasting and postprandial 0.5, 1, 2, 3, 4h will be measured
- Serum intercellular adhesion molecule-1 (ICAM-1) concentration [4 hours]
Concentration of serum ICAM-1 at fasting and postprandial 0.5, 1, 2, 3, 4h will be measured
- Serum Amyloid A1(SAA1) concentration [4 hours]
Concentration of serum SAA1 at fasting and postprandial 0.5, 1, 2, 3, 4h will be measured
- Serum Tumor Necrosis Factor-α (TNF-α) concentration [4 hours]
Concentration of serum TNF-α at fasting and postprandial 0.5, 1, 2, 3, 4h will be measured
- Serum interleukin-10(IL-10) concentration [4 hours]
Concentration of serum IL-10 at fasting and postprandial 0.5, 1, 2, 3, 4h will be measured
- Serum interleukin-1b(IL-1b) concentration [4 hours]
Concentration of serum IL-1b at fasting and postprandial 0.5, 1, 2, 3, 4h will be measured
- Serum C-reactive protein(CRP) concentration [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
- metabolomics [4 hours]
Metabonomics will be measured by liquid chromatograph-mass spectrometer, metabolic pathway analysis results will be reported.
- Single nucleotide polymorphism (SNPs) [baseline]
Mutations at specific sites will be detected by gene chip。
- Gut microbiota 16S rDNA sequencing [baseline]
Gut microbiota 16S rDNA will be sequenced, community composition will be analysed and the community composition differences between individuals will be reported.
Eligibility Criteria
Criteria
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)
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Waist circumference ≥90 cm (men), ≥ 80 cm (women).
-
total triglyceride ≥ 1.7 mmol/L.
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HDL-c <1.03 mmol/L in men, <1.3 mmol/L in women.
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systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmHg.
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Fasting plasma glucose ≥ 5.6 mmol/L.
Exclusion Criteria:
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Diabetes or a history of medical or surgical events that may significantly affect the study outcome, including medication for diabetes, cholesterol lowering medication
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Pregnancy or lactation
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Gastrointestinal diseases
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Severe renal disease or liver disease
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Severe pituitary or thyroid diseases;
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Mental disorders or current use of antidepressants
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Cardiovascular disease, stroke or phase three hypertension
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Cancer or receiving radiotherapy and chemotherapy within 5 years
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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)
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Suffering from AIDS, hepatitis A, hepatitis B and other infectious diseases
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Attempting to changing bodyweight
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Physical disability.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Longhua Hospital Shanghai University of Traditional Chinese Medicine | Shanghai | Shanghai | China | 200031 |
Sponsors and Collaborators
- Chinese Academy of Sciences
- Shanghai University of Traditional Chinese Medicine
Investigators
- Principal Investigator: Xu Lin, PhD, Shanghai Institute of Nutrition and Health, Chinese Acadamy of Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CAS-MH-201911