Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
55 participants
INTERVENTIONAL
2005-03-31
2006-02-28
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Low carbohydrate and low fat.
dietary intervention
12 weeks of dietary intervention
2
Low carbohydrate fat rich diet
dietary intervention
12 weeks of dietary intervention
3
A balanced low fat diet
dietary intervention
12 weeks of dietary intervention
Interventions
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dietary intervention
12 weeks of dietary intervention
Eligibility Criteria
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Inclusion Criteria
2. 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
3.Subjects who had participated in another weight loss-study or slimming diet within two months prior to the study.
12 Years
18 Years
ALL
Yes
Sponsors
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Rabin Medical Center
OTHER
Responsible Party
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Rabin Medical Center
Principal Investigators
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Moshe Phillip, Professor
Role: PRINCIPAL_INVESTIGATOR
Rabin Medical Center
Locations
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Schnider children medical center
Petah Tikva, I, Israel
Countries
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Other Identifiers
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Low carbohydrate diets
Identifier Type: -
Identifier Source: secondary_id
rmc003187ctil
Identifier Type: -
Identifier Source: org_study_id