- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02283151
The Effects of a Very Low Carbohydrate Diet Intervention on Weight Control in Overweight/Obese Patients in China
November 2, 2014 updated by: Jia Sun, Southern Medical University, China
The study was designed to investigate the effects of a very low carbohydrate diet (VLCD) intervention on weight control in overweight/obese patients in China.All the subjects were randomly assigned to experiment group and control group.
The experimental group was given individual instructions on how to follow the VLCD (very low carbohydrate diet).
The control group was given an energy-restricted diet.The energy-restricted diet (ER diet) was designed in the traditional Chinese style with an initial target for a total energy intake of 1200 kcal/d (5021 kJ/d).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
121 obese or overweight patients were enrolled in the study and 23 patients were dropped out (43 male, 55 female, aged≥18 years, BMI≥24 kg/m2) from the outpatient clinic of endocrinology and metabolism department of Southern Medical University Affiliated ZhuJiang Hospital.
All the subjects were randomly assigned to experiment group and control group.
The experimental group was given individual instructions on how to follow the VLCD (very low carbohydrate diet).
Energy intake was restricted to less than 800kcal/day (3349kJ/d) (carbohydrate intake < 20g/d).
All daily meals were replaced as follows: a cup of soybean milk (200 mL) and a boiled egg at breakfast; a diet nutrition bar (106 Kcal: 2.8 g carbohydrate, 11.2 g protein and 5.6 g fat; Nutriease Health Technology Co., Ltd., Hangzhou, China), nonstarchy vegetables (<200 kcal), and 50 g protein from meat (i.e., beef, lean pork, skinned chicken, fish) at lunch and dinner.
Supplementation of multivitamins and minerals was provided per day.
The energy-restricted diet (ER diet) was designed in the traditional Chinese style with an initial target for a total energy intake of 1200 kcal/d (5021 kJ/d).
Subjects were also encouraged to drink at least 1.8 litres of water per day, and asked to maintain their habitual level of physical activity.
Compliance with the diet and physical activity level was checked at weekly visits.
Study Type
Interventional
Enrollment (Actual)
98
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- overweight or obese healthy volunteers (43 male, 55 female, aged≥18years, BMI≥24 kg/m2)
Exclusion Criteria:
- pregnant or plan for pregnant
- lactation or postmenopausal women
- use of any prescription medication in previous 2 months
- had any weight loss diet or pill during the past 6 months
- consuming>20 g/day of alcohol
- tobacco use within 6 month
- cardiovascular or endocrine disease history
- hypertension history or current elevated blood pressure (systolic blood pressure (SBP): ≥150 mmHg; diastolic blood pressure (DBP)≥90 mmHg; current treatment for hypertension)
- diabetes mellitus
- acute or chronic infections
- hepatopathy, kidney disease, gastrointestinal disease or any other acute or chronic diseases requiring treatment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: energy-restricted diet
The control group was given an energy-restricted diet (ER diet).
Energy-restricted diet was designed in the traditional Chinese style with an initial target for a total energy intake of 1200 kcal/d (5021 kJ/d).
Supplementation of multivitamins and minerals was provided per day.
|
The control group was given an energy-restricted diet (ER diet).
Energy-restricted diet was designed in the traditional Chinese style with an initial target for a total energy intake of 1200 kcal/d (5021 kJ/d).
|
Experimental: diet nutrition bar
The experimental group was given individual instructions on how to follow the VLCD (very low carbohydrate diet).
Energy intake was restricted to less than 800kcal/day (3349kJ/d) (carbohydrate intake < 20g/d).
Carbohydrate-rich foods, such as white rice, steamed bread and tubers, were substituted with fish, poultry and plant oil.
All daily meals were replaced as follows: a cup of soybean milk (200 mL) and a boiled egg at breakfast; a diet nutrition bar (106 Kcal: 2.8 g carbohydrate, 11.2 g protein and 5.6 g fat; Nutriease Health Technology Co., Ltd., Hangzhou, China), nonstarchy vegetables (<200 kcal), and 50 g protein from meat (i.e., beef, lean pork, skinned chicken, fish) at lunch and dinner.
Supplementation of multivitamins and minerals was provided per day.
|
The experimental group was given individual instructions on how to follow the VLCD (very low carbohydrate diet).
Energy intake was restricted to less than 800kcal/day (3349kJ/d) (carbohydrate intake < 20g/d).
All daily meals were replaced as follows: a cup of soybean milk (200 mL) and a boiled egg at breakfast; a diet nutrition bar(Nutriease Health Technology Co., Ltd., Hangzhou, China), nonstarchy vegetables (<200 kcal), and 50 g protein from meat at lunch and dinner.
Supplementation of multivitamins and minerals was provided per day.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
body composition
Time Frame: before intervention and after 12 weeks' intervention
|
body composition included weight, body mass index, body fat, body fat percentage, visceral fat, waist-to-hip ratio
|
before intervention and after 12 weeks' intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jia Sun, PhD., Southern Medical University, China
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2013
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
October 26, 2014
First Submitted That Met QC Criteria
November 2, 2014
First Posted (Estimate)
November 5, 2014
Study Record Updates
Last Update Posted (Estimate)
November 5, 2014
Last Update Submitted That Met QC Criteria
November 2, 2014
Last Verified
October 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Grant No.81300689
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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