Status:
COMPLETED
Cross-Over Multicentre Study in Adolescents
Lead Sponsor:
Federico II University
Conditions:
Overweight
Hyperlipidemia
Eligibility:
FEMALE
13-16 years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Age 13-16 yrs
- Written informed consent
- Menstrual cycle for at least 6 months
- Overweight
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2008
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00635544
Start Date
January 1 2007
End Date
April 1 2008
Last Update
January 28 2009
Active Locations (4)
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1
Department of Nutrition and Dietetics, Harokopio University
Athens, Greece, 17671
2
Pécsi Tudományegyetem Anyagcseregondozó
Pécs, Hungary, 7623
3
Dipartimento di Pediatria Università di Napoli "Federico II"
Napoli, Italy, 80131
4
Instituto del Frio. Departamento de Metabolismo y Nutrición
Madrid, Spain, 28040