Cross-Over Multicentre Study in Adolescents

Not Applicable

Completed

• Conditions: Hyperlipidemia; Overweight
• Interventions: Other: dietary treatment

• Registration Number: NCT00635544
• Lead Sponsor: Federico II University

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 centres.

Secondary objectives are to evaluate the effects of the two standardized diets on selected hormones and variables linked to inflammatory status.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2008-01
• Study First Submitted: 2008-03-06
• Study First Submitted QC: 2008-03-06
• Study First Posted: 2008-03-13
• Study Completion: 2008-04
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-27
• Last Update Posted: 2009-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	dietary treatment	dietary treatment with a low-glycemic index high-fibre diet (LGI-HF)
1	dietary treatment	dietary treatment with a high-glycemic index low-fibre diet (HGI-LF)

Primary Outcome Measures

Name	Time	Method
blood glucose and lipids	after 3 weeks of dietary treatment

Secondary Outcome Measures

Name	Time	Method
blood hormones and inflammatory status parameters	after 3 weeks of dietary treatment

Trial Locations

Locations (4)

Pécsi Tudományegyetem Anyagcseregondozó; 🇭🇺 Pecs, Hungary

Department of Nutrition and Dietetics, Harokopio University; 🇬🇷 Athens, Greece

Instituto del Frio. Departamento de Metabolismo y Nutrición; 🇪🇸 Madrid, Spain

Dipartimento di Pediatria Università di Napoli "Federico II"; 🇮🇹 Napoli, Italy