Low Carbohydrates in Obese Adolescents

NCT00575900 | Completed

• 2 other identifiers: rmc003187ctilLow carbohydrate diets
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Adolescent obesity,; low carbohydrate diets; metabolic risk factors; BMI

Outcome Measures

Primary Outcomes (1)

• BMI, BMI-SDS, Body fat percentage, waist circumference

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

Secondary Outcomes (1)

• Blood metabolic profile, CRP, Ghrelin and Leptin levels, Resting energy expenditure, Psychological parameters

  At baseline, after 12 weeks of intervention and after 9 weeks of follow-up

Study Arms (3)

1

EXPERIMENTAL

Low carbohydrate and low fat.

Behavioral: dietary intervention

2

EXPERIMENTAL

Low carbohydrate fat rich diet

Behavioral: dietary intervention

3

ACTIVE COMPARATOR

A balanced low fat diet

Behavioral: dietary intervention

Interventions

dietary intervention BEHAVIORAL

12 weeks of dietary intervention

1; 2; 3

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Subjects who had participated in another weight loss-study or slimming diet within two months prior to the study.

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Schnider children medical center

Petah Tikva, I, Israel

Location

MeSH Terms

Conditions

Obesity; Pediatric Obesity

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Moshe Phillip, Professor

  Rabin Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 16, 2007
• First Posted: December 18, 2007
• Study Start: March 1, 2005
• Study Completion: February 1, 2006
• Last Updated: December 18, 2007

Record last verified: 2007-12

Locations

IL (1)