Status:
COMPLETED
Trans Fatty Acids and Cardiovascular Risk Factors
Lead Sponsor:
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Conditions:
Cardiovascular Disease
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
Background: Detrimental effects of consumption of industrial trans fatty acids (TFA) from partially hydrogenated vegetable oils (PHVO) on cardiovascular disease (CVD) risk factors are well documented...
Detailed Description
Design: This is a double blind, controlled, randomised, cross-over, single center clinical trial. Product(s) to be tested: Food items (butter, cheese and biscuits) manufactured using (i) an experim...
Eligibility Criteria
Inclusion
- HDL cholesterol, g/L \> 0.4
- Triacylglycerol g/L \<1.50
- LDL Cholesterol g/L \<1.60
- Affiliated to National Health Insurance
- Waist size \< 102 cm (men) or 88 cm (women)
- Normal blood pressure (diastolic \<90 mm Hg, systolic \<140 mm Hg)
- Normal liver functions (γ-GT, transaminases, alkaline phosphatase)
- Normal white blood cells count (4-10 g/L)
- For women: effective contraception
- Subject giving his/her written informed consent
- Subject willing to comply with the study procedures
- Subject considered as normal after clinical examination and medical questionnaire
Exclusion
- Reported food allergies
- Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study
- Hepatic or renal impairments
- Positive serologies to HIV or HCV, determined on blood sample
- For women, pregnant or presently attempting to get pregnant (-HCG blood test) or menopause or lactating
- Blood donation done less than 2 months before the start of the study
- Chronic pathologies: diabetes (fasted glycaemia \> 6,1 mmol/L), hypertriglyceridemia (≥1.50 g/L), hypertension (systolic blood pressure ≥ 140 mm Hg and/or diastolic blood pressure ≥ 90 mm Hg), cardiovascular diseases, chronic inflammatory diseases
- Intestine, cardiovascular, kidney and cancer pathologies in the last 5 years
- Previous heavy intestine surgery (except appendicectomy)
- Previous medical and/or surgery judged by the investigator as incompatible with this study
- High variation (\> 5%) of body weight during the last 3 months
- Consuming nutritional supplements which could interfered with lipid metabolism (fish oil capsule, vitamins, soja lecithins,…)
- Heavy consumer of alcohol (evaluated thanks to the values of the following hepatic enzymes: -GT, ASAT, ALAT)
- Smoker or ex-smoker who stopped smoking less than 1 month before V0
- Practicing intensive physical exercise (\> 3 h per week)
- Vegetarian or vegan
- Taking medication for depressive or psychiatric state
- Being under someone's supervision
- Refusal to be registered on the National Volunteers Data file
- Disliking butter, margarine, cheese, biscuits and/or vegetable oil
- Dietary habits unreliable to controlled food intake
- Being in exclusion on the National Volunteers Data file
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00439582
Start Date
August 1 2005
End Date
December 1 2005
Last Update
November 21 2025
Active Locations (1)
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1
Centre de Recherche en Nutrition Humaine (CRNH), UEN, Laboratoire de Nutrition Humaine
Clermont-Ferrand, France, 63009