Low Carbohydrates in Obese Adolescents
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
dietary intervention
Sponsored by

About this trial
This is an interventional treatment trial for Obesity focused on measuring Adolescent obesity,, low carbohydrate diets, metabolic risk factors, BMI
Eligibility Criteria
Inclusion Criteria:
- aged 12 to 18
- body mass index (BMI) values greater than the 95th percentile for age and gender according to the growth charts of the Center for Disease Control and Prevention.
Exclusion Criteria:
1.Patients with a chronic disease (such as diabetes, renal, heart or liver diseases, thyroid function disorder, or diagnosed psychological disorder). 2.Patients receiving weight-loss-inducing medication.
3.Subjects who had participated in another weight loss-study or slimming diet within two months prior to the study.
Sites / Locations
- Schnider children medical center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
1
2
3
Arm Description
Low carbohydrate and low fat.
Low carbohydrate fat rich diet
A balanced low fat diet
Outcomes
Primary Outcome Measures
BMI, BMI-SDS, Body fat percentage, waist circumference
Secondary Outcome Measures
Blood metabolic profile, CRP, Ghrelin and Leptin levels, Resting energy expenditure, Psychological parameters
Full Information
NCT ID
NCT00575900
First Posted
December 16, 2007
Last Updated
December 16, 2007
Sponsor
Rabin Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00575900
Brief Title
Low Carbohydrates in Obese Adolescents
Official Title
Comparison Between Low Carbohydrate Low Fat, Low Carbohydrate High Fat and Balanced Low Fat Diets in the Treatment of Obesity in Adolescents- a Randomized Controlled Trail.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Rabin Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A three arms open,randomized interventional study in order to compare the impact of low carbohydrate diets with different protein and fat ratios versus a standard balanced diet on BMI and metabolic parameters in obese adolescents.
55 obese adolescents (12-18y, BMI > 95th percentile) were randomly allocated to one of three 12-weeks diet regimens: low-carbohydrate low-fat, low-carbohydrate high-fat or balanced low-fat diet, followed by 9-months follow-up. Weight, Height, waist circumference, lipid profile, glucose, insulin, liver enzymes, renal functions, C-reactive protein, leptin, ghrelin and resting energy expenditure were measured in the morning after over-night fast at baseline, during the 12-weeks of intervention and after 9-months of follow-up.
Detailed Description
A three arms open,randomized interventional study in order to compare the impact of low carbohydrate diets with different protein and fat ratios versus a standard balanced diet on BMI and metabolic parameters in obese adolescents.
Study design:
The study included 12 weeks of intervention followed by 9 months of follow up, between March 2005 to February 2006. Participants were randomly allocated to one of three diet groups.
Group 1: Low carbohydrate, low fat, protein rich diet containing 1200 kcal a day, 60-gr carbohydrates (20%), 40-gr fat (30%), 150-gr protein (50%).
Group 2: Low carbohydrate fat rich diet containing 1200 kcal a day, 60-gr carbohydrates (20%), 80-gr fat (60%), 60-gr protein (20%).
Group 3: A balanced low fat diet containing 1200 kcal a day, 150 - 180-gr carbohydrates (50 - 60%), 40-gr fat (30%), 60-gr protein (20%).
All participant received menus and detailed instruction according to their group.
During the intervention participant attended weekly sessions with a dietitian and a psychologist and a tests and measures scheduled for each time point were performed (see Measures section). In some sessions the participants were requested to fill-out self reports food dairies. All received general recommendations to exercise physical activity.
At the end of the intervention period (12th week), all participants were given instruction for a balanced maintenance diet for the following year.
measures: Anthropometric assessment (weight,height, waist circumference) included baseline and weekly measurement during the 12- week intervention, and thereafter every three months for 9-months of follow-up. Body composition was evaluated at baseline and after the 12- week intervention, after overnight fasting by bioimpedance analysis (BIA). Resting energy expenditure (REE) was assessed at baseline and after the 12- week intervention, in the morning after overnight fasting by means of indirect calorimetry. Urine was collected every week during the intervention period for assay of ketone and protein level. Fasting blood tests were preformed at baseline, weeks 7 and 12, and at the end of the follow-up to measure the following parameters: total cholesterol, Low Density Lipoprotein (LDL), HDL cholesterol, triglycerides, glucose, insulin, blood urea nitrogen, creatinine, total protein, liver enzymes (AST, ALT, GGT ),renal functions (urea, creatinine, electrolytes, uric acid), electrolyte level, Insulin like growth factor (IGF1), haemoglobin, C-reactive protein (CRP), TSH, free T4, iron, vitamin B12, folic acid ,leptin ,and ghrelin.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Adolescent obesity,, low carbohydrate diets, metabolic risk factors, BMI
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Low carbohydrate and low fat.
Arm Title
2
Arm Type
Experimental
Arm Description
Low carbohydrate fat rich diet
Arm Title
3
Arm Type
Active Comparator
Arm Description
A balanced low fat diet
Intervention Type
Behavioral
Intervention Name(s)
dietary intervention
Intervention Description
12 weeks of dietary intervention
Primary Outcome Measure Information:
Title
BMI, BMI-SDS, Body fat percentage, waist circumference
Time Frame
At baseline visit, end of 12 weeks of intervention and every three months after during the 9 months follow-up
Secondary Outcome Measure Information:
Title
Blood metabolic profile, CRP, Ghrelin and Leptin levels, Resting energy expenditure, Psychological parameters
Time Frame
At baseline, after 12 weeks of intervention and after 9 weeks of follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
aged 12 to 18
body mass index (BMI) values greater than the 95th percentile for age and gender according to the growth charts of the Center for Disease Control and Prevention.
Exclusion Criteria:
1.Patients with a chronic disease (such as diabetes, renal, heart or liver diseases, thyroid function disorder, or diagnosed psychological disorder). 2.Patients receiving weight-loss-inducing medication.
3.Subjects who had participated in another weight loss-study or slimming diet within two months prior to the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moshe Phillip, Professor
Organizational Affiliation
Rabin Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schnider children medical center
City
Petach-Tikva
State/Province
I
Country
Israel
12. IPD Sharing Statement
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Low Carbohydrates in Obese Adolescents
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