Cross-Over Multicentre Study in Adolescents - Full Text View

Purpose

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
Overweight Hyperlipidemia	Other: dietary treatment

ChemIDplus related topics:

Calcium polycarbophil Psyllium

U.S. FDA Resources

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

Further study details as provided by Federico II University:

Primary Outcome Measures:

blood glucose and lipids [ Time Frame: after 3 weeks of dietary treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

blood hormones and inflammatory status parameters [ Time Frame: after 3 weeks of dietary treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	80
Study Start Date:	January 2007
Estimated Study Completion Date:	April 2008
Estimated 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)	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)

Eligibility

Ages Eligible for Study:	13 Years to 16 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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 ilnesses) of hyperlipidemia or altered glucose metabolism
Severe hyperlipidemia (total cholesterol > 300 mg/dL or tryglicerides >300 mg/dL)
Severe hypertension
Positive history for eating disorders
Any regular drug treatment
Any food allergy and intolerance

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00635544

Contacts


Contact: Luca Scalfi, MD	+39 081 7752652	scalfi@unina.it

Locations


Greece
	Department of Nutrition and Dietetics, Harokopio University	Completed
	Athens, Greece, 17671

Hungary
	Pécsi Tudományegyetem Anyagcseregondozó	Completed
	Pecs, Hungary, 7623

Italy
	Dipartimento di Pediatria Università di Napoli "Federico II"	Recruiting
	Napoli, Italy, 80131
	Contact: Luca Scalfi, MD +39 081 7752652 scalfi@unina.it

Spain
	Instituto del Frio. Departamento de Metabolismo y Nutrición	Recruiting
	Madrid, Spain, 28040
	Contact: Ascensión Marcos, Pharm D +34915492300 amarcos@if.csic.es

Sponsors and Collaborators

Federico II University

More Information

HELENA study web page This link exits the ClinicalTrials.gov site

Responsible Party:	University of Napoli "Federico II" ( Prof Luca Scalfi )
Study ID Numbers:	H3, Contract number: 007034
First Received:	March 6, 2008
Last Updated:	March 6, 2008
ClinicalTrials.gov Identifier:	NCT00635544
Health Authority:	Italy: Ethics Committee

Keywords provided by Federico II University:

Adolescence

Overweight

Dietary Fiber

Glycemic Index

Healthy lifestyle

Study placed in the following topic categories:

Body Weight

Signs and Symptoms

Metabolic Diseases

Hyperlipidemias

Overweight

Healthy

Calcium polycarbophil

Psyllium

Metabolic disorder

Dyslipidemias

Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on September 23, 2008

Sponsored by:	Federico II University
Information provided by:	Federico II University
ClinicalTrials.gov Identifier:	NCT00635544