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

January 27, 2009 updated by: Federico II University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, 17671
        • Department of Nutrition and Dietetics, Harokopio University
  • Hungary
      • Pecs, Hungary, 7623
        • Pécsi Tudományegyetem Anyagcseregondozó
  • Italy
      • Napoli, Italy, 80131
        • Dipartimento di Pediatria Università di Napoli "Federico II"
  • Spain
      • Madrid, Spain, 28040
        • Instituto del Frio. Departamento de Metabolismo y Nutrición

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 16 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
blood glucose and lipids
Time Frame: after 3 weeks of dietary treatment
after 3 weeks of dietary treatment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

March 6, 2008

First Submitted That Met QC Criteria

March 6, 2008

First Posted (Estimate)

March 13, 2008

Study Record Updates

Last Update Posted (Estimate)

January 28, 2009

Last Update Submitted That Met QC Criteria

January 27, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H3
  • Contract number: 007034

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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