Status:
COMPLETED
The Intervention Study of Dietary Intake on Energy Expenditure
Lead Sponsor:
Chinese Academy of Sciences
Conditions:
Healthy and Overweight/ Obesity Males
Eligibility:
MALE
18-45 years
Phase:
NA
Brief Summary
This study is a randomized crossover (2 × 3) dietary intervention. 40 male volunteers(20 normal weight, 20 overweight / obesity, no other serious disease or metabolic abnormalities) aged 18-45 years a...
Detailed Description
With the largest population of obesity and diabetes, China is suffering from heavy burden of obesity and major complications such as cardiovascular disease, type 2 diabetes and other major metabolic d...
Eligibility Criteria
Inclusion
- Male subjects, aged 18-45 years
- 20 normal weight (18.5≤ BMI\<24) and 20 overweight / obesity (BMI ≥24)
- No participating in other clinical studies within previous 3 months
Exclusion
- Alcoholic (100 grams of alcohol per drink, or 250 grams of rice wine, or 5 bottles of beer, ≥ 5 times a week)
- Diabetic patients or the use of insulin, hypoglycemic agents
- Taking antihypertensive drugs (diuretics, β blockers drugs, etc.) or lipid lowering drugs (class "bite", bile acids, statins, etc.) at present or once (within 6 months before the experiment)
- Having serious cardiovascular and cerebrovascular diseases at present or before, may interfere with the normal operation of the experiment (such as heart failure, myocardial infarction, cerebral infarction, acute myocarditis, severe arrhythmia, receiving interventional therapy, etc.)
- Having severe gastrointestinal diseases that affect food digestion and absorption, such as severe diarrhea in the past 3 months (3 or more times per day and lasting for 3 days or more); severe constipation in the past 3 months (2 times a week or less, accompanied by difficulties in defecation)
- Having received drug treatment over the past 3 months due to the following diseases: cholecystitis, gastrointestinal ulcers; urinary tract infection, acute pyelonephritis, cystitis; having undergone any surgery, in addition to appendicitis, hernia surgery; having taken or taking drugs that will affect the digestion and absorption system
- Attempting to change weight recently(weight loss, being on a diet, or weight gain)
- Subjects with severe liver and kidney disease (alanine aminotransferase, serum creatinine exceeded 1.5 times of the normal range set by the hospital)
- Subjects with severe thyroid disease (hyperthyroidism or hypothyroidism) or pituitary disease
- Subjects with anemia (hemoglobin \<120 g per liter)
- Subjects with cancer or who have received radiotherapy or chemotherapy within five years
- Having any mental illness; epilepsy patients or receiving antiepileptic treatment; using antidepressants
- Suffering from AIDS, hepatitis A, hepatitis B or other infectious diseases
- Physical disability
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2018
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03231618
Start Date
September 1 2017
End Date
January 1 2018
Last Update
January 25 2018
Active Locations (1)
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1
Institute for Nutritional Sciences, Chinese Academy of Sciences
Shanghai, Shanghai Municipality, China, 200031