Cross-Over Multicentre Study in Adolescents

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-04-30

Brief Summary

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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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Detailed Description

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Conditions

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Overweight Hyperlipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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1

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

Group Type EXPERIMENTAL

dietary treatment

Intervention Type OTHER

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

2

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

Group Type ACTIVE_COMPARATOR

dietary treatment

Intervention Type OTHER

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

Interventions

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dietary treatment

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

Intervention Type OTHER

dietary treatment

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

13 Years

Maximum Eligible Age

16 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes