OverweightHELENA-COMSNCT00635544
Cross-Over Multicentre Study in Adolescents
A study testing dietary treatment in people with Overweight and Hyperlipidemia, run by Federico II University at 4 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 13 to 16 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight, Hyperlipidemia
- What is being tested?
- dietary treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Jan 2007to Apr 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 16 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 13-16 yrs
- Written informed consent
- Menstrual cycle for at least 6 months
- Overweight
Who cannot join
- 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
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- 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
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Greece1 site
Department of Nutrition and Dietetics, Harokopio University
Athens, 17671
Italy1 site
Dipartimento di Pediatria Università di Napoli "Federico II"
Naples, 80131
Spain1 site
Instituto del Frio. Departamento de Metabolismo y Nutrición
Madrid, 28040
About this study
Official title: Healthy Life Style in Europe by Nutrition in Adolescence: Cross-Over Multicentre Study
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
- Being tested
- dietary treatment
- Keywords
- Adolescence, Overweight, Dietary Fiber, Glycemic Index, Healthy lifestyle
- Medical subject headings
- Overweight, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary treatmentOther
dietary treatment with a high-glycemic index low-fibre diet (HGI-LF)
dietary treatmentOther
dietary treatment with a low-glycemic index high-fibre diet (LGI-HF)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | dietary treatment with a high-glycemic index low-fibre diet (HGI-LF) Receives: Other: dietary treatment |
| 2 | Active comparator | dietary treatment with a low-glycemic index high-fibre diet (LGI-HF) Receives: Other: dietary treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood glucose and lipids
Measured: after 3 weeks of dietary treatment
Secondary outcomes (1)
blood hormones and inflammatory status parameters
Measured: after 3 weeks of dietary treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2008 (estimated)
- Study startJan 2007
- Primary completionJan 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00635544
- Sponsor's protocol ID
- H3
- Other IDs
- Contract number: 007034
- Acronym
- HELENA-COMS
- Status last verified
- Jan 2009
- First submitted
- 6 Mar 2008
- Last updated
- 28 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Life Style in Europe by Nutrition in Adolescence: Cross-Over Multicentre Study
- ClinicalTrials.gov ID
- NCT00635544
- Acronym / sponsor ID
- HELENA-COMS / H3
- Conditions
- Overweight, Hyperlipidemia
- Keywords
- Adolescence, Overweight, Dietary Fiber, Glycemic Index, Healthy lifestyle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 13 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: dietary treatmentdietary treatment with a high-glycemic index low-fibre diet (HGI-LF) |
| 2 | Active comparator | Other: dietary treatmentdietary treatment with a low-glycemic index high-fibre diet (LGI-HF) |
Who may qualify
- Ages
- 13 to 16 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age 13-16 yrs
- Written informed consent
- Menstrual cycle for at least 6 months
- Overweight
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dietary treatmentdietary treatment with a high-glycemic index low-fibre diet (HGI-LF) | Other | 1 |
| dietary treatmentdietary treatment with a low-glycemic index high-fibre diet (LGI-HF) | Other | 2 |
Primary outcome
blood glucose and lipids
Time frame: after 3 weeks of dietary treatment
1 secondary outcome
blood hormones and inflammatory status parameters
Time frame: after 3 weeks of dietary treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2009.
- HELENA study web pageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dietary treatment in people with Overweight and Hyperlipidemia, run by Federico II University at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Greece, Hungary, Italy, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood glucose and lipids (time frame: after 3 weeks of dietary treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2009.