Low-Carbohydrate Diet Intervention on Body Weight
Primary Purpose
Over Weight, Obesity
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
low carbohydrate diet
Calories restricted diet
Sponsored by
About this trial
This is an interventional treatment trial for Over Weight focused on measuring over weight, obesity
Eligibility 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.
Sites / Locations
- Institute for Nutritional Sciences, Chinese Academy of Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
B
A
Arm Description
Subjects will be supplied with low carbohydrate diet for 12 weeks.
Subjects will be supplied with calories restricted diet for 12 weeks
Outcomes
Primary Outcome Measures
weight
Secondary Outcome Measures
body fat mass
waist circumference
body mass index
fast glucose
total cholesterol
triglyceride
LDL-C
HDL-C
blood pressure
urinary ketone
Full Information
NCT ID
NCT01358890
First Posted
May 23, 2011
Last Updated
February 27, 2012
Sponsor
Chinese Academy of Sciences
Collaborators
Harvard School of Public Health (HSPH)
1. Study Identification
Unique Protocol Identification Number
NCT01358890
Brief Title
Low-Carbohydrate Diet Intervention on Body Weight
Official Title
Effect of Low-Carbohydrate or Restricted-Calories Diet on Body Weight
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Sciences
Collaborators
Harvard School of Public Health (HSPH)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Over Weight, Obesity
Keywords
over weight, obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
B
Arm Type
Experimental
Arm Description
Subjects will be supplied with low carbohydrate diet for 12 weeks.
Arm Title
A
Arm Type
Experimental
Arm Description
Subjects will be supplied with calories restricted diet for 12 weeks
Intervention Type
Other
Intervention Name(s)
low carbohydrate diet
Intervention Description
Dietary carbohydrate diet was restricted to 20 gram/day within the first week, then increase gradually to 120 gram/day
Intervention Type
Other
Intervention Name(s)
Calories restricted diet
Intervention Description
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 Measure Information:
Title
weight
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
body fat mass
Time Frame
12 weeks
Title
waist circumference
Time Frame
12 weeks
Title
body mass index
Time Frame
12 weeks
Title
fast glucose
Time Frame
12 weeks
Title
total cholesterol
Time Frame
12 weeks
Title
triglyceride
Time Frame
12 weeks
Title
LDL-C
Time Frame
12 weeks
Title
HDL-C
Time Frame
12 weeks
Title
blood pressure
Time Frame
12 weeks
Title
urinary ketone
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xu Lin, PhD
Organizational Affiliation
Institute for Nutritional Sciecnes, Chinese Acadamy of Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Nutritional Sciences, Chinese Academy of Sciences
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200031
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
34656033
Citation
Ma Y, Sun Y, Sun L, Liu X, Zeng R, Lin X, Li Y. Effects of gut microbiota and fatty acid metabolism on dyslipidemia following weight-loss diets in women: Results from a randomized controlled trial. Clin Nutr. 2021 Nov;40(11):5511-5520. doi: 10.1016/j.clnu.2021.09.021. Epub 2021 Sep 23.
Results Reference
derived
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Low-Carbohydrate Diet Intervention on Body Weight
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