NCT00635544CompletedNot Applicable
Healthy Life Style in Europe by Nutrition in Adolescence: Cross-Over Multicentre Study
Federico II University8 sites in 4 countries80 target enrollmentStarted: January 1, 2007Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 80
- Locations
- 8
- Primary Endpoint
- blood glucose and lipids
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 13 Years to 16 Years (Child)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
blood glucose and lipids
Time Frame: after 3 weeks of dietary treatment
Secondary Outcomes
- blood hormones and inflammatory status parameters(after 3 weeks of dietary treatment)
Investigators
Study Sites (8)
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