Low-Carbohydrate Diet Intervention on Body Weight

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01358890
Recruitment Status : Completed
First Posted : May 24, 2011
Last Update Posted : February 28, 2012
Harvard School of Public Health
Information provided by (Responsible Party):
Xu Lin, 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.

Condition or disease Intervention/treatment Phase
Over Weight Obesity Other: low carbohydrate diet Other: Calories restricted diet Phase 2 Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
U.S. FDA Resources

Arm Intervention/treatment
Experimental: B
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
Experimental: A
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

Primary Outcome Measures :
  1. weight [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. body fat mass [ Time Frame: 12 weeks ]
  2. waist circumference [ Time Frame: 12 weeks ]
  3. body mass index [ Time Frame: 12 weeks ]
  4. fast glucose [ Time Frame: 12 weeks ]
  5. total cholesterol [ Time Frame: 12 weeks ]
  6. triglyceride [ Time Frame: 12 weeks ]
  7. LDL-C [ Time Frame: 12 weeks ]
  8. HDL-C [ Time Frame: 12 weeks ]
  9. blood pressure [ Time Frame: 12 weeks ]
  10. urinary ketone [ Time Frame: 12 weeks ]

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Ages Eligible for Study:   30 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01358890

China, Shanghai
Institute for Nutritional Sciences, Chinese Academy of Sciences
Shanghai, Shanghai, China, 200031
Sponsors and Collaborators
Chinese Academy of Sciences
Harvard School of Public Health
Principal Investigator: Xu Lin, PhD Institute for Nutritional Sciecnes, Chinese Acadamy of Sciences

Responsible Party: Xu Lin, Principal Investigator, Chinese Academy of Sciences Identifier: NCT01358890     History of Changes
Other Study ID Numbers: 30930081/C150502-LC
First Posted: May 24, 2011    Key Record Dates
Last Update Posted: February 28, 2012
Last Verified: February 2012

Keywords provided by Xu Lin, Chinese Academy of Sciences:
over weight

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms