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Effects of Low Carbohydrate Diet and Caloric Control Intervention on Weight Control in Overweight and Obese Patients: a Multi-center, Randomized, Controlled Clinical Study

Effects of Low Carbohydrate Diet and Caloric Control Intervention on Weight Control in Overweight and Obese Patients: a Multi-center, Randomized, Controlled Clinical Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800015156
Enrollment
Unknown
Registered
2018-03-11
Start date
2018-03-12
Completion date
Unknown
Last updated
2018-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight and Obesity

Interventions

Control group:According to the 'Dietary Guidelines for Chinese Residents', participants should intake at least 240g staple food (800kcal). The diet plan provides 55%-65% energy from carbohydrates. The
Low carbohydrate diet with no calorie restriction group:Nutrition food bars are instead of two daily meals. Diet plan: Breakfast:The quantity of food is not restricted but avoiding overeating. Type of
Normal diet with caloric restriction group:To limit daily total calories from 1200kcal to 1500kcal according to the proportion of nutrients in dietary guidelines of Chinese residents, participants sho
Low carbohydrate diet with calorie restriction group:Nutrition food bar instead of two daily meals. Diet plans: Breakfast: 200ml of sugar-free soy milk or milk, a boiled egg and 50g vegetables (150 kc

Sponsors

Zhujiang Hospital, Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Subjects included in this study should meet the following criteria: 1. Men and women are eligible at the age of 18-65 years old; 2. The definition of overweight and obesity in Chinese adults is based on the "2003 Guidance on Prevention and Control of Overweight and Obesity in Chinese Adults": 1) 24 kg/? = BMI <28 kg/? for overweight; 2) BMI=28kg/? for obesity; 3. Moderate weight changes and exercises over the last 30 days (less than 60 minutes of exercise every week). 4. Voluntarily participate in and cooperate with and sign informed consent.

Exclusion criteria

Exclusion criteria: The subject may not be included in this study if any of the following exclusion criteria are met: 1. Pregnant women or women who are planning to be pregnant during the study, women who are currently in lactating, or who have not received highly effective, medical-approved birth control methods; 2. Participants who have received weight loss treatments or taking psychiatric drugs, hormonal drugs, anti-hypertensive drugs, hypoglycemic drugs and other drugs which may cause weight gain or decrease in past 30 days. 3. Gastrointestinal diseases or surgical history, including intestinal obstruction, intestinal ulcers, weight loss surgery or banding surgery, gastrointestinal anastomosis, bowel resection; 4. Type 1 diabetes, type 2 diabetes, Cushing syndrome, and other endocrine disorders caused by obesity; 5. Poor control of Severe hypertension: SBP=180 mmHg and/or DBP=110 mmHg;SBP3 times the normal upper limit (ULN) or serum total bilirubin (TB)>34.2µmol/L(>2 mg/dL); 7. Patients with the following nephrotic history or kidney disease-related characteristics: 1) History of unstable or acute kidney disease; 2) Patients with moderate/severe renal injury or end-stage renal disease (eGFR 1800 mg/g; 4) Serum creatinine (Cr)=133µmol/L (=150mg/dL) in male subjects; the serum Cr=124µmol/L(>1.40mg/dL) in female subjects; 8. Any of the following cardiovascular diseases occured in the last 6 months: 1) Myocardial infarction; 2) Cardiac surgery or revascularization (coronary artery bypass surgery/percutaneous transluminal coronary angioplasty); 3) Unstable angina; 4) Congestive heart failure (New York Heart Society grade III or IV); 5) Transient ischemic attack or significant cerebrovascular disease. 9. Combined with malignant tumors, multiple organ dysfunction and other chronic wasting diseases; 10. History of acute and chronic infection, surgery or severe trauma within the past 3 months; 11. Known immunocompromised states, including but not limited to individuals who have undergone organ transplantation or acquired immunodeficiency syndrome (AIDS); 12. It is currently judged by the investigator to be unstable or severe cardiovascular, kidney, liver, hematology, oncology, endocrine, psychiatric or rheumatic diseases; 13. Blood donation or donation of blood products, blood transfusion or participation in clinical studies in the last 30 days requires blood more than 400 mL; 14. Use any other test drug within 30 days or within 5 half-lives of other test drugs; 15. History of drug abuse, alcohol or drug abuse over the past 6 months; 16. In the case of a researcher's judgment, it is not possible to follow the program's subject, and there are patients with severe physical or mental illness that may affect effectiveness or safety; 17. Engage in heavy manual labor; 18. Unable to cooperate with and complete the entire intervention due to other factors.

Design outcomes

Primary

MeasureTime frame
Absolute changes of BMI;

Secondary

MeasureTime frame
Serum Lipid;Index of glucose metabolism;Index of inflammation;flora;

Countries

China

Contacts

Public ContactHong Chen

Department of Endocrinology and Metabolism, Zhujiang Hospital, Southern Medical University

rubychq@163.com+86 020-62782330

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 15, 2026