Status:
COMPLETED
Dietary Pattern and Metabolic Health Study
Lead Sponsor:
Chinese Academy of Sciences
Collaborating Sponsors:
Ruijin Hospital
Conditions:
Diet
PreDiabetes
Eligibility:
All Genders
25-60 years
Phase:
NA
Brief Summary
This is a single-blind, randomized trial. Based on inclusion and exclusion criteria, 253 eligible volunteers, who were 25-60 years old, with overweight/obese and prediabetes are assigned to one of thr...
Detailed Description
Nowadays, the prevalence of type 2 diabetes and its related metabolic diseases is rapidly rising in China. Obesity and early pathoglycemia will increase the risk of diabetes and related cardiovascular...
Eligibility Criteria
Inclusion
- Age between 25 to 60 years old
- 0 ≤ BMI ≤ 40.0 kg/m2
- fasting glucose≥5.6 mmol/L
Exclusion
- Diabetes or use of insulin or other hypoglycemic medications
- Pregnancy or lactation
- Trying to change body weight in the way
- Use of antibiotic in the preceding 3 months for 3-serial days
- Obvious changes of medication in the preceding 3 months
- History of drug or alcohol abuse or other substance abuse; (Alcohol abuse is defined as regular alcohol consumption \> 40 g/day)
- Any severe liver or renal diseases
- Severe gastrointestinal diseases
- Surgical events preceding 1 year (except appendicitis or hernia surgery)
- Severe cardiovascular or cerebrovascular diseases or phase three hypertension
- Implantation of heart stent
- Cancer or receiving radiotherapy and chemotherapy within 5 years
- Hyperthyroidism or hypothyroidism
- Suffering from hepatitis B, tuberculosis, AIDS and other infectious diseases
- Any mental disorders or current use of antidepressants
- Food contraindications or allergies to foods included in the intervention
- Cognitive disability
- Participated in any other clinical studies within 3 months
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2019
Estimated Enrollment :
253 Patients enrolled
Trial Details
Trial ID
NCT03856762
Start Date
March 1 2019
End Date
September 30 2019
Last Update
August 26 2020
Active Locations (1)
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1
Ruijin hospital; SAIC FAW-Volkswagen Automobile Co
Shanghai, Shanghai Municipality, China, 200031