Low-Carbohydrate Diet Intervention on Body Weight

This study has been completed.
Sponsor:
Collaborator:
Harvard School of Public Health
Information provided by (Responsible Party):
Xu Lin, Chinese Academy of Sciences
ClinicalTrials.gov Identifier:
NCT01358890
First received: May 23, 2011
Last updated: February 27, 2012
Last verified: February 2012
  Purpose
  • 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 Intervention Phase
Over Weight
Obesity
Other: low carbohydrate diet
Other: Calories restricted diet
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Low-Carbohydrate or Restricted-Calories Diet on Body Weight

Resource links provided by NLM:


Further study details as provided by Chinese Academy of Sciences:

Primary Outcome Measures:
  • weight [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • body fat mass [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • waist circumference [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • body mass index [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • fast glucose [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • total cholesterol [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • triglyceride [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • LDL-C [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • HDL-C [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • blood pressure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • urinary ketone [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: May 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01358890

Locations
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
Investigators
Principal Investigator: Xu Lin, PhD Institute for Nutritional Sciecnes, Chinese Acadamy of Sciences
  More Information

No publications provided

Responsible Party: Xu Lin, Principal Investigator, Chinese Academy of Sciences
ClinicalTrials.gov Identifier: NCT01358890     History of Changes
Other Study ID Numbers: 30930081/C150502-LC
Study First Received: May 23, 2011
Last Updated: February 27, 2012
Health Authority: China: Ethics Committee

Keywords provided by Chinese Academy of Sciences:
over weight
obesity

Additional relevant MeSH terms:
Body Weight
Obesity
Overweight
Signs and Symptoms
Overnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on July 26, 2014