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Completed

NCT Number: NCT00635544

Cross-Over Multicentre Study in Adolescents

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.

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Key information

Conditions

Overweight Body Weight Dyslipidemias Hyperlipidemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

13 year–16 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dietary treatment

Other

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

Primary outcomes

  1. blood glucose and lipids

    Time frame: after 3 weeks of dietary treatment

Secondary outcomes

  1. blood hormones and inflammatory status parameters

    Time frame: after 3 weeks of dietary treatment

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

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

Acronym: HELENA-COMS

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 13, 2008
Registry last updated
Jan 28, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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