Cross-Over Multicentre Study in Adolescents (HELENA-COMS)

This study has been completed.
Sponsor:
Information provided by:
Federico II University
ClinicalTrials.gov Identifier:
NCT00635544
First received: March 6, 2008
Last updated: January 27, 2009
Last verified: January 2009
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Healthy Life Style in Europe by Nutrition in Adolescence: Cross-Over Multicentre Study

Resource links provided by NLM:


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
Study Completion Date: April 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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)
Active Comparator: 2
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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
Sponsors and Collaborators
Federico II University
  More Information

Additional Information:
No publications provided

Responsible Party: Prof Luca Scalfi, University of Napoli "Federico II"
ClinicalTrials.gov Identifier: NCT00635544     History of Changes
Other Study ID Numbers: H3, Contract number: 007034
Study First Received: March 6, 2008
Last Updated: January 27, 2009
Health Authority: Italy: Ethics Committee

Keywords provided by Federico II University:
Adolescence
Overweight
Dietary Fiber
Glycemic Index
Healthy lifestyle

Additional relevant MeSH terms:
Hyperlipidemias
Overweight
Body Weight
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014