Low-Carbohydrate Diet Intervention on Body Weight
|ClinicalTrials.gov Identifier: NCT01358890|
Recruitment Status : Completed
First Posted : May 24, 2011
Last Update Posted : February 28, 2012
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Over Weight Obesity||Other: low carbohydrate diet Other: Calories restricted diet||Phase 2 Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effect of Low-Carbohydrate or Restricted-Calories Diet on Body Weight|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||August 2011|
Subjects will be supplied with low carbohydrate diet for 12 weeks.
Other: low carbohydrate diet
Dietary carbohydrate diet was restricted to 20 gram/day within the first week, then increase gradually to 120 gram/day
Subjects will be supplied with calories restricted diet for 12 weeks
Other: 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
- weight [ Time Frame: 12 weeks ]
- body fat mass [ Time Frame: 12 weeks ]
- waist circumference [ Time Frame: 12 weeks ]
- body mass index [ Time Frame: 12 weeks ]
- fast glucose [ Time Frame: 12 weeks ]
- total cholesterol [ Time Frame: 12 weeks ]
- triglyceride [ Time Frame: 12 weeks ]
- LDL-C [ Time Frame: 12 weeks ]
- HDL-C [ Time Frame: 12 weeks ]
- blood pressure [ Time Frame: 12 weeks ]
- urinary ketone [ Time Frame: 12 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01358890
|Institute for Nutritional Sciences, Chinese Academy of Sciences|
|Shanghai, Shanghai, China, 200031|
|Principal Investigator:||Xu Lin, PhD||Institute for Nutritional Sciecnes, Chinese Acadamy of Sciences|