Status:
RECRUITING
Impact of Ultra-processed Foods on Cardiometabolic Risk Factors
Lead Sponsor:
Laval University
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Cardiometabolic Risk
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to examine in a 2x2 factorial RCT what feature(s) of ultra-processed foods (UPFs) contribute to cardiometabolic risk in men and women. The project's hypotheses are :...
Detailed Description
This study is a parallel group 2x2 factorial randomized controlled trial, in which diet is fully controlled. A total of 120 men and women covering a broad range of adiposity and cardiometabolic risk f...
Eligibility Criteria
Inclusion
- Body mass index (BMI):18 to 35 kg/m2
- Stable weight over the last 3 months (variation of less than 5 kg)
- LDL-cholesterol \< 5.0 mmol/L
- HbA1c \< 6.5%
- Office blood pressure \<150/90 mmHg
- Non-smokers or smokers of less than 10 cigarettes a day
Exclusion
- Pregnant or breast-feeding women
- Alcohol consumption of more than 7 drinks per week
- Women: contraceptives for less than 3 months or hormone therapy for less than 6 months
- Medication to treat hypercholesterolemia, diabetes or hypertension
- Diagnosis of cardiovascular disease, diabetes, hypertension, cancer
- Food allergies or aversions to any of the foods on the experimental menus
- Being on a diet or following a special diet
- Daytime MAPA blood pressure \>150/90
Key Trial Info
Start Date :
September 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2028
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06538831
Start Date
September 25 2024
End Date
August 31 2028
Last Update
October 17 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre Nutrition, santé et société (NUTRISS), INAF, Université Laval
Québec, Quebec, Canada, G1V 0A6