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

Primary Purpose

Overweight, Hyperlipidemia

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
dietary treatment
dietary treatment
Sponsored by
Federico II University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Overweight focused on measuring Adolescence, Overweight, Dietary Fiber, Glycemic Index, Healthy lifestyle

Eligibility Criteria

13 Years - 16 Years (Child)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Nutrition and Dietetics, Harokopio University
  • Pécsi Tudományegyetem Anyagcseregondozó
  • Dipartimento di Pediatria Università di Napoli "Federico II"
  • Instituto del Frio. Departamento de Metabolismo y Nutrición

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

dietary treatment with a high-glycemic index low-fibre diet (HGI-LF)

dietary treatment with a low-glycemic index high-fibre diet (LGI-HF)

Outcomes

Primary Outcome Measures

blood glucose and lipids

Secondary Outcome Measures

blood hormones and inflammatory status parameters

Full Information

First Posted
March 6, 2008
Last Updated
January 27, 2009
Sponsor
Federico II University
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1. Study Identification

Unique Protocol Identification Number
NCT00635544
Brief Title
Cross-Over Multicentre Study in Adolescents
Acronym
HELENA-COMS
Official Title
Healthy Life Style in Europe by Nutrition in Adolescence: Cross-Over Multicentre Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Federico II University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Hyperlipidemia
Keywords
Adolescence, Overweight, Dietary Fiber, Glycemic Index, Healthy lifestyle

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
dietary treatment with a high-glycemic index low-fibre diet (HGI-LF)
Arm Title
2
Arm Type
Active Comparator
Arm Description
dietary treatment with a low-glycemic index high-fibre diet (LGI-HF)
Intervention Type
Other
Intervention Name(s)
dietary treatment
Intervention Description
dietary treatment with a high-glycemic index low-fibre diet (HGI-LF)
Intervention Type
Other
Intervention Name(s)
dietary treatment
Intervention Description
dietary treatment with a low-glycemic index high-fibre diet (LGI-HF)
Primary Outcome Measure Information:
Title
blood glucose and lipids
Time Frame
after 3 weeks of dietary treatment
Secondary Outcome Measure Information:
Title
blood hormones and inflammatory status parameters
Time Frame
after 3 weeks of dietary treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Department of Nutrition and Dietetics, Harokopio University
City
Athens
ZIP/Postal Code
17671
Country
Greece
Facility Name
Pécsi Tudományegyetem Anyagcseregondozó
City
Pecs
ZIP/Postal Code
7623
Country
Hungary
Facility Name
Dipartimento di Pediatria Università di Napoli "Federico II"
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Instituto del Frio. Departamento de Metabolismo y Nutrición
City
Madrid
ZIP/Postal Code
28040
Country
Spain

12. IPD Sharing Statement

Links:
URL
http://www.helenastudy.com
Description
HELENA study web page

Learn more about this trial

Cross-Over Multicentre Study in Adolescents

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