Cardiovascular Risk FactorBELINDANCT02899416
Better Life by Nutrition During Adulthood
An observational study of Cardiovascular Risk Factor, run by University Hospital, Lille at 1 site in France.
Trial summary
BELINDA is a follow'up of subjects included 10 years ago in HELENA study which was a cross-sectional study carried out from 2006 to 2007 in more than 3500 adolescents aged from 12.5 to 17.5 years old through 10 Europeans towns from 9 countries. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- 23 Feb 2017to 25 Mar 2022
- Phase
- Observational
- 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 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: BELINDA is a follow'up of subjects included 10 years ago in HELENA study which was a cross-sectional study carried out from 2006 to 2007 in more than 3500 adolescents aged from 12.5 to 17.5 years old through 10 Europeans towns from 9 countries. BELINDA will retest subjects from Lille and Ghent
Who may be able to join
- Women of men participating to HELENA study 2006-2007
- Aged from 20 to 35 years.
- Signed informed consent
Who cannot join
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Better Life by Nutrition During Adulthood : Identification of Factors Present in Adolescence Cardiovascular Risk in Young Adults
BELINDA is a follow'up of subjects included 10 years ago in HELENA study which was a cross-sectional study carried out from 2006 to 2007 in more than 3500 adolescents aged from 12.5 to 17.5 years old through 10 Europeans towns from 9 countries.
BELINDA main objective is to assess CV risk using PDAY score (Pathobiological Determinants of Atherosclerosis in Youth) during young adulthood (20 to 31 years) and analyze lifestyle risk factors from adolescence (12 to 18 years). This analyze may define new CV risk factors and risk population cluster.
Read the detailed description
BELINDA subjects from Lille, Ghent , Zaragoza and Roma will be re-tested using a part of HELENA test battery and some new evaluation criteria.
- Conditions
- Cardiovascular Risk Factor
- Keywords
- cardiovascular risk, young adulthood
What is being measured
The primary outcome is the main question the study is designed to answer.
PDAY score (Pathobiological Determinants of Atherosclerosis in Youth)
PDAY score is a composite score which will be calculated using adult data including Gender, HDL non cholesterol, HDL cholesterol. Glucose level, Blood pressure, Tobacco consumption and BMI.
Measured: one day
Secondary outcomes (9)
Diet Quality Index Score
data collected using HELENA-DIAT, an electronic dietary recall, data in DQI score unit.
DQI score is ranking from 0 to 9 unit and is based on three basic principles for a healthy diet: quality; diversity; balance. Furthermore, the daily diet was divided into nine recommended food groups, namely (1) water, (2) bread and cereals, (3) grains and potatoes, (4) vegetables, (5) fruit, (6) milk products (7), cheese, (8) meat, fish, eggs and substitutes, and (9) fats and oils.
Measured: 2 days
Ratio total energy intake
data collected using HELENA-DIAT, an electronic dietary recall, data in kcal/d, data for recommended total energy intake will be collected using national reference chart.
Measured: 2 days
ratio of dietary n-6/n-3 polyunsaturated fatty acids (PUFA)
data collected using HELENA-DIAT, an electronic dietary recall, data in ratio calculated using a food composition data base. PUFA is expressed in mg/day daily intake.
Measured: 2 days
consumption in dietary salt intake
data collected using HELENA-DIAT, an electronic dietary recall, data in mg/day daily intake calculated using a food composition data base.
Measured: 2 days
Physical activity
data collected using a GT3X accelerometer data in daily counts/min
Measured: 7 days
Endurance
data collected using Dr Leger Shuttle run test, data in VO2max ml/kg/min
Measured: 1 day
Ratio waist-to-hip
data collected using anthropometric measurements, data in ratio. Data are expressed in centimeter
Measured: 1 day
Fat mass
data collected using anthropometric measurements, data in % of fat mass, expressed in kg
Measured: 1 day
Education level
data collected using a Socio-economic questionnaire, data in Education level 8 digits
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study start23 Feb 2017
- Primary completion25 Mar 2022
- Study completion25 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Risk FactorStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric Gottrand, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02899416
- Sponsor's protocol ID
- 2015_24
- Other IDs
- 2016-A00386-45
- Acronym
- BELINDA
- Status last verified
- Sep 2022
- First submitted
- 24 Aug 2016
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Morcel J, Beghin L, Michels N, De Ruyter T, Drumez E, Cailliau E, Polito A, Le Donne C, Barnaba L, Azzini E, De Henauw S, Miguel Berges ML, Cacau LT, Moreno LA, Gottrand F. Nutritional and physical fitness parameters in adolescence impact cardiovascular health in adulthood. Clin Nutr. 2024 Aug;43(8):1857-1864. doi: 10.1016/j.clnu.2024.06.022. Epub 2024 Jun 26.
PubMed 38959665Beghin L, Morcel J, Michels N, Leroy M, Ternynck C, Labreuche J, De Henauwn S, Miguel-Berges ML, Polito A, Moreno LA, Gottrand F. High nutritional knowledge during adolescence is associated with healthier dietary habits in adulthood: a longitudinal cohort study. Eur J Nutr. 2026 Jun 2;65(4):149. doi: 10.1007/s00394-026-03968-y.
PubMed 42228155
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Better Life by Nutrition During Adulthood : Identification of Factors Present in Adolescence Cardiovascular Risk in Young Adults
- ClinicalTrials.gov ID
- NCT02899416
- Acronym / sponsor ID
- BELINDA / 2015_24
- Conditions
- Cardiovascular Risk Factor
- Keywords
- cardiovascular risk, young adulthood
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 23 Feb 2017 (actual)
- Primary completion
- 25 Mar 2022 (actual)
- Study completion
- 25 Mar 2022 (actual)
- First posted
- 14 Sep 2016 (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.
BELINDA is a follow'up of subjects included 10 years ago in HELENA study which was a cross-sectional study carried out from 2006 to 2007 in more than 3500 adolescents aged from 12.5 to 17.5 years old through 10 Europeans towns from 9 countries.
BELINDA main objective is to assess CV risk using PDAY score (Pathobiological Determinants of Atherosclerosis in Youth) during young adulthood (20 to 31 years) and analyze lifestyle risk factors from adolescence (12 to 18 years). This analyze may define new CV risk factors and risk population cluster.
Detailed description
BELINDA subjects from Lille, Ghent , Zaragoza and Roma will be re-tested using a part of HELENA test battery and some new evaluation criteria.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- BELINDA is a follow'up of subjects included 10 years ago in HELENA study which was a cross-sectional study carried out from 2006 to 2007 in more than 3500 adolescents aged from 12.5 to 17.5 years old through 10 Europeans towns from 9 countries. BELINDA will retest subjects from Lille and Ghent
Key inclusion criteria (3 listed)
- Women of men participating to HELENA study 2006-2007
- Aged from 20 to 35 years.
- Signed informed consent
Key exclusion criteria (1 listed)
- Pregnant or lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PDAY score (Pathobiological Determinants of Atherosclerosis in Youth)
Time frame: one day
PDAY score is a composite score which will be calculated using adult data including Gender, HDL non cholesterol, HDL cholesterol. Glucose level, Blood pressure, Tobacco consumption and BMI.
9 secondary outcomes
Diet Quality Index Score
Time frame: 2 days
Ratio total energy intake
Time frame: 2 days
ratio of dietary n-6/n-3 polyunsaturated fatty acids (PUFA)
Time frame: 2 days
consumption in dietary salt intake
Time frame: 2 days
Physical activity
Time frame: 7 days
Endurance
Time frame: 1 day
Ratio waist-to-hip
Time frame: 1 day
Fat mass
Time frame: 1 day
Education level
Time frame: 1 day
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 23 Dec 2025.
- Results publication: PubMed 38959665Morcel J, Beghin L, Michels N, De Ruyter T, Drumez E, Cailliau E, Polito A, Le Donne C, Barnaba L, Azzini E, De Henauw S, Miguel Berges ML, Cacau LT, Moreno LA, Gottrand F. Nutritional and physical fitness parameters in adolescence impact cardiovascular health in adulthood. Clin Nutr. 2024 Aug;43(8):1857-1864. doi: 10.1016/j.clnu.2024.06.022. Epub 2024 Jun 26.
- Derived from this study: PubMed 42228155Beghin L, Morcel J, Michels N, Leroy M, Ternynck C, Labreuche J, De Henauwn S, Miguel-Berges ML, Polito A, Moreno LA, Gottrand F. High nutritional knowledge during adolescence is associated with healthier dietary habits in adulthood: a longitudinal cohort study. Eur J Nutr. 2026 Jun 2;65(4):149. doi: 10.1007/s00394-026-03968-y.
- Individual participant dataSharing planned: No
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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.
Frédéric Gottrand, MD, PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Risk Factor, run by University Hospital, Lille at 1 site in France.
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 3 inclusion and 1 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 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
PDAY score (Pathobiological Determinants of Atherosclerosis in Youth) (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02899416, which also lists 2 linked publications.
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 23 Dec 2025; AzTrials last refreshed its copy on 6 Nov 2026.