Cross-Over Multicentre Study in Adolescents

Overweight Clinical Trial

— HELENA-COMS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00635544
• Other study ID #: H3
• Secondary ID: Contract number:
• Status: Completed
• Phase: N/A
• First received: March 6, 2008
• Last updated: January 27, 2009
• Start date: January 2007
• Est. completion date: April 2008

Study information

• Verified date: January 2009
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 13 Years to 16 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias
• Overweight

Intervention

Other:
• dietary treatment
dietary treatment with a high-glycemic index low-fibre diet (HGI-LF)
• dietary treatment
dietary treatment with a low-glycemic index high-fibre diet (LGI-HF)

Locations

Country	Name	City	State
Greece	Department of Nutrition and Dietetics, Harokopio University	Athens
Hungary	Pécsi Tudományegyetem Anyagcseregondozó	Pecs
Italy	Dipartimento di Pediatria Università di Napoli "Federico II"	Napoli
Spain	Instituto del Frio. Departamento de Metabolismo y Nutrición	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Countries where clinical trial is conducted

Greece,  Hungary,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood glucose and lipids		after 3 weeks of dietary treatment	Yes
Secondary	blood hormones and inflammatory status parameters		after 3 weeks of dietary treatment	Yes

External Links

•   HELENA study web page