Low Carbohydrates in Obese Adolescents

December 16, 2007 updated by: Rabin Medical Center

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
    • I
      • Petach-Tikva, I, Israel
        • Schnider children medical center

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

12 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. aged 12 to 18
  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:

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.

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Low carbohydrate and low fat.
Behavioral: dietary intervention
12 weeks of dietary intervention
EXPERIMENTAL: 2
Low carbohydrate fat rich diet
Behavioral: dietary intervention
12 weeks of dietary intervention
ACTIVE_COMPARATOR: 3
A balanced low fat diet
Behavioral: dietary intervention
12 weeks of dietary intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
At baseline visit, end of 12 weeks of intervention and every three months after during the 9 months follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
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
At baseline, after 12 weeks of intervention and after 9 weeks of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

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

March 1, 2005

Study Completion (ACTUAL)

February 1, 2006

Study Registration Dates

First Submitted

December 16, 2007

First Submitted That Met QC Criteria

December 16, 2007

First Posted (ESTIMATE)

December 18, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

December 18, 2007

Last Update Submitted That Met QC Criteria

December 16, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • rmc003187ctil
  • Low carbohydrate diets

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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