Cross-Over Multicentre Study in Adolescents

Study Overview
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Brief Summary
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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.

Official Title
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Healthy Life Style in Europe by Nutrition in Adolescence: Cross-Over Multicentre Study

Conditions
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Overweight, Hyperlipidemia

Intervention / Treatment
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* Other: dietary treatment
* Other: dietary treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 13-16 yrs Written informed consent Menstrual cycle for at least 6 months Overweight Exclusion Criteria: Taking part simultaneously in another research trial Involvement in physical training (>4 h/week of vigorous physical activity) Any dietary treatment in the previous two months Body weight changes > 3 kg in the previous two months Gastrointestinal diseases, irritable bowel syndrome, or positive history for recurrent gastrointestinal symptoms such as nausea, vomiting, bloating, epigastric pain, abdominal pain, abdominal discomfort, flatulence, severe constipation Kidney diseases Type 1 or type 2 diabetes Thyroid or other hormonal diseases Other secondary causes (including illnesses) of hyperlipidemia or altered glucose metabolism Severe hyperlipidemia (total cholesterol > 300 mg/dL or triglycerides >300 mg/dL) Severe hypertension Positive history for eating disorders Any regular drug treatment Any food allergy and intolerance

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>dietary treatment with a high-glycemic index low-fibre diet (HGI-LF) | Other: dietary treatment<br>* dietary treatment with a high-glycemic index low-fibre diet (HGI-LF)<br>|
| Active Comparator: 2<br>dietary treatment with a low-glycemic index high-fibre diet (LGI-HF) | Other: dietary treatment<br>* dietary treatment with a low-glycemic index high-fibre diet (LGI-HF)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood glucose and lipids |  | after 3 weeks of dietary treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood hormones and inflammatory status parameters |  | after 3 weeks of dietary treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescence, Overweight, Dietary Fiber, Glycemic Index, Healthy lifestyle