Cross-Over Multicentre Study in Adolescents

NCT00635544 | Completed DMC

• 2 other identifiers: H3Contract number: 007034
• Study Type: interventional
• Target: 80
• Locations: 4 countries
• Sites: 4

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.

Conditions

Overweight; Hyperlipidemia

Keywords

Adolescence; Overweight; Dietary Fiber; Glycemic Index; Healthy lifestyle

Outcome Measures

Primary Outcomes (1)

• blood glucose and lipids

  after 3 weeks of dietary treatment

Secondary Outcomes (1)

• blood hormones and inflammatory status parameters

  after 3 weeks of dietary treatment

Study Arms (2)

1

EXPERIMENTAL

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

Other: dietary treatment

2

ACTIVE COMPARATOR

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

Other: dietary treatment

Interventions

dietary treatment OTHER

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

1

Eligibility Criteria

• Age: 13 Years - 16 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age 13-16 yrs
• Written informed consent
• Menstrual cycle for at least 6 months
• Overweight

You may not qualify if:

• 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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (4)

Department of Nutrition and Dietetics, Harokopio University

Athens, 17671, Greece

Location

Pécsi Tudományegyetem Anyagcseregondozó

Pécs, 7623, Hungary

Location

Dipartimento di Pediatria Università di Napoli "Federico II"

Napoli, 80131, Italy

Location

Instituto del Frio. Departamento de Metabolismo y Nutrición

Madrid, 28040, Spain

Location

Related Links

• HELENA study web page

MeSH Terms

Conditions

Overweight; Hyperlipidemias

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 6, 2008
• First Posted: March 13, 2008
• Study Start: January 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: April 1, 2008
• Last Updated: January 28, 2009

Record last verified: 2009-01

Locations

GR (1); ES (1); HU (1); IT (1)