Low-Carbohydrate Diet Intervention on Body Weight

Phase 2

Completed

• Conditions: Over Weight; Obesity
• Interventions: Other: low carbohydrate diet; Other: Calories restricted diet

• Registration Number: NCT01358890
• Lead Sponsor: Chinese Academy of Sciences

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-23
• Study First Submitted QC: 2011-05-23
• Study First Posted: 2011-05-24
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-27
• Last Update Posted: 2012-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	low carbohydrate diet	Subjects will be supplied with low carbohydrate diet for 12 weeks.
A	Calories restricted diet	Subjects will be supplied with calories restricted diet for 12 weeks

Primary Outcome Measures

Name	Time	Method
weight	12 weeks

Secondary Outcome Measures

Name	Time	Method
body fat mass	12 weeks
waist circumference	12 weeks
body mass index	12 weeks
fast glucose	12 weeks
total cholesterol	12 weeks
triglyceride	12 weeks
LDL-C	12 weeks
HDL-C	12 weeks
blood pressure	12 weeks
urinary ketone	12 weeks

Trial Locations

Locations (1)

Institute for Nutritional Sciences, Chinese Academy of Sciences; 🇨🇳 Shanghai, Shanghai, China