Better Life by Nutrition During Adulthood

Cardiovascular Risk Factor Clinical Trial

— BELINDA  

Official title:

Better Life by Nutrition During Adulthood : Identification of Factors Present in Adolescence Cardiovascular Risk in Young Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02899416
• Other study ID #: 2015_24
• Secondary ID: 2016-A00386-45
• Status: Recruiting
• Start date: February 23, 2017
• Est. completion date: March 2022

Study information

• Verified date: October 2021
• Source: University Hospital, Lille
• Contact: Frédéric Gottrand, MD,PhD
• Phone: (0)3 20 44 60 58
• Email: frederic.gottrand[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: March 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 35 Years

Eligibility

Inclusion Criteria:

• Women of men participating to HELENA study 2006-2007
• Aged from 20 to 35 years.
• Signed informed consent

Exclusion Criteria:

• Pregnant or lactating women

Related Conditions & MeSH terms

• Cardiovascular Risk Factor

Locations

Country	Name	City	State
France	CHRU,Hôpital Jeanne de Flandres	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	one day
Secondary	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.	2 days
Secondary	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.	2 days
Secondary	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.	2 days
Secondary	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.	2 days
Secondary	Physical activity	data collected using a GT3X accelerometer data in daily counts/min	7 days
Secondary	Endurance	data collected using Dr Leger Shuttle run test, data in VO2max ml/kg/min	1 day
Secondary	Ratio waist-to-hip	data collected using anthropometric measurements, data in ratio. Data are expressed in centimeter	1 day
Secondary	Fat mass	data collected using anthropometric measurements, data in % of fat mass, expressed in kg	1 day
Secondary	Education level	data collected using a Socio-economic questionnaire, data in Education level 8 digits	1 day