Low-Carbohydrate Diet Intervention on Body Weight

Obesity Clinical Trial

Official title:

Effect of Low-Carbohydrate or Restricted-Calories Diet on Body Weight

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01358890
• Other study ID #: 30930081/C150502-LC
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 23, 2011
• Last updated: February 27, 2012
• Start date: May 2011
• Est. completion date: August 2011

Study information

• Verified date: February 2012
• Source: Chinese Academy of Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

• The primary aim of this study is to determine the adherence of low- carbohydrate among Chinese.

• Then compare the effect of low-carbohydrate and traditional Chinese but restricted-calories diet on weight loss and metabolic traits.

Description:

Obesity is a well established risk factor for type 2 diabetes mellitus, hypertension, dyslipidemia and cardiovascular disease. Along with rapid nutritional and lifestyle transition featured as increased energy dense diet intake and reduced physical activity, the prevalence of obesity has reached epidemic level and affected more than 70 million Chinese adults nowadays. Previous studies suggested that low-carbohydrate diet was an effective and safe way to lose weight and had potential benefit on lipids profiles. However, it is still unknown whether this diet can be feasible to control the epidemic of obesity and its related metabolic diseases among Chinese, whose carbohydrate consumption contribute approximately 55% of total energy intake.

Therefore, the aim of this pilot study is to investigate the adherence and effectiveness of two weight-loss diets among Chinese. This will be a randomized, controlled clinical trial. A total of 50 overweight or obese nurse assistants will be randomly assigned to receive a low-carbohydrate diet or a traditional high-carbohydrate Chinese but restricted-calories diet for 12 weeks. The adherence of study protocol and effects of the two diets on body weight, waist circumference, body fat, fasting glucose and lipid profile will be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

• overweight/obese (BMI =24 kg/m2)

Exclusion Criteria:

• Pregnancy or lactation;

• Serum creatinine and blood urea nitrogen level beyond the clinical reference value;

• alanine aminotransferase and aspartate aminotransferase beyond the reference levels;

• Gastrointestinal problems that would prevent them from complying with the specified feeding conditions;

• Received gastrointestinal surgery (except for appendicitis or hernia);

• Severer CVD;

• Active cancer;

• Mental diseases, epilepsia or using anti-depression drugs;

• Participating in other scientific studies within 3 months before the study.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Over Weight
• Overweight

Intervention

Other:
• low carbohydrate diet
Dietary carbohydrate diet was restricted to 20 gram/day within the first week, then increase gradually to 120 gram/day
• Calories restricted diet
Total energy intake is restricted to 1200 kcal/day for women. Energy from carbohydrate, protein and fat will be kept to approximate 55%, 20% and 25%, respectively. Moreover, saturated fat and dietary cholesterol are restricted to at most 10% energy and 300 mg/day, respectively

Locations

Country	Name	City	State
China	Institute for Nutritional Sciences, Chinese Academy of Sciences	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Chinese Academy of Sciences	Harvard School of Public Health

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight		12 weeks	No
Secondary	body fat mass		12 weeks	No
Secondary	waist circumference		12 weeks	No
Secondary	body mass index		12 weeks	No
Secondary	fast glucose		12 weeks	No
Secondary	total cholesterol		12 weeks	No
Secondary	triglyceride		12 weeks	No
Secondary	LDL-C		12 weeks	No
Secondary	HDL-C		12 weeks	No
Secondary	blood pressure		12 weeks	No
Secondary	urinary ketone		12 weeks	No