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Sponsored by: |
Federico II University |
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Information provided by: | Federico II University |
ClinicalTrials.gov Identifier: | NCT00635544 |
The main objective of this study is to evaluate the effects of two diets with different glycemic index and fibre content on glucose metabolism and plasma lipid profile of 80 adolescents in 4 European centres.
Secondary objectives are to evaluate the effects of the two standardized diets on selected hormones and variables linked to inflammatory status.
Condition | Intervention |
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Overweight Hyperlipidemia |
Other: dietary treatment |
Study Type: | Interventional |
Study Design: | Health Services Research, Randomized, Open Label, Crossover Assignment, Efficacy Study |
Official Title: | Healthy Life Style in Europe by Nutrition in Adolescence: Cross-Over Multicentre Study |
Estimated Enrollment: | 80 |
Study Start Date: | January 2007 |
Study Completion Date: | April 2008 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
dietary treatment with a high-glycemic index low-fibre diet (HGI-LF)
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Other: dietary treatment
dietary treatment with a high-glycemic index low-fibre diet (HGI-LF)
|
2: Active Comparator
dietary treatment with a low-glycemic index high-fibre diet (LGI-HF)
|
Other: dietary treatment
dietary treatment with a low-glycemic index high-fibre diet (LGI-HF)
|
Ages Eligible for Study: | 13 Years to 16 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Greece | |
Department of Nutrition and Dietetics, Harokopio University | |
Athens, Greece, 17671 | |
Hungary | |
Pécsi Tudományegyetem Anyagcseregondozó | |
Pecs, Hungary, 7623 | |
Italy | |
Dipartimento di Pediatria Università di Napoli "Federico II" | |
Napoli, Italy, 80131 | |
Spain | |
Instituto del Frio. Departamento de Metabolismo y Nutrición | |
Madrid, Spain, 28040 |
Responsible Party: | University of Napoli "Federico II" ( Prof Luca Scalfi ) |
Study ID Numbers: | H3, Contract number: 007034 |
Study First Received: | March 6, 2008 |
Last Updated: | January 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00635544 History of Changes |
Health Authority: | Italy: Ethics Committee |
Adolescence Overweight Dietary Fiber Glycemic Index Healthy lifestyle |
Body Weight Signs and Symptoms Metabolic Diseases Hyperlipidemias Overweight |
Healthy Metabolic Disorder Dyslipidemias Lipid Metabolism Disorders |
Body Weight Signs and Symptoms Metabolic Diseases Hyperlipidemias |
Overweight Dyslipidemias Lipid Metabolism Disorders |