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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00575900 |
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Date of registration:
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16/12/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Low Carbohydrates in Obese Adolescents
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Scientific title:
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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. |
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Date of first enrolment:
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March 2005 |
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Target sample size:
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55 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00575900 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Israel
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Contacts
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Name:
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Moshe Phillip, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rabin Medical Center |
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Key inclusion & exclusion criteria
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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.
Age minimum:
12 Years
Age maximum:
18 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Obesity
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Intervention(s)
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Behavioral: dietary intervention
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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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]
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Secondary ID(s)
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rmc003187ctil
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Low carbohydrate diets
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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