Cross-Over Multicentre Study in Adolescents

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00635544

Acronym

HELENA-COMS

Enrollment

Registered

2008-03-13

Start date

2007-01-31

Completion date

2008-04-30

Last updated

2009-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperlipidemia, Overweight

Keywords

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

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.

Interventions

OTHERdietary treatment

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

13 Years to 16 Years

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

Design outcomes

Primary

Measure	Time frame
blood glucose and lipids	after 3 weeks of dietary treatment

Secondary

Measure	Time frame
blood hormones and inflammatory status parameters	after 3 weeks of dietary treatment

Countries

Greece, Hungary, Italy, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026