Actively Recruiting
Impact of Ultra-processed Foods on Cardiometabolic Risk Factors
Led by Laval University · Updated on 2024-10-17
120
Participants Needed
1
Research Sites
205 weeks
Total Duration
On this page
Sponsors
L
Laval University
Lead Sponsor
C
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 : 1. that the nutrient composition of UPFs (high SFA, free sugar and sodium) per se has deleterious impacts on cardiometabolic risk factors; 2. that the industrial techniques and processes of UPFs per se do not. Participants will be randomly assigned to one of 4 groups consistent with the 2x2 factorial design of the study: 1- the nutrient composition of foods (low vs. high in SFA, free sugar and sodium) and 2- the degree of industrial techniques and food processing (little to no vs.important amounts of UPFs). All foods will be provided to participants under isocaloric conditions during the 6-week dietary intervention. Participants will have to consume one of the 4 experimental diets for 6 weeks.
CONDITIONS
Official Title
Impact of Ultra-processed Foods on Cardiometabolic Risk Factors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body mass index (BMI) between 18 and 35 kg/m2
- Stable weight over the last 3 months with less than 5 kg variation
- LDL-cholesterol below 5.0 mmol/L
- HbA1c below 6.5%
- Office blood pressure below 150/90 mmHg
- Non-smoker or smokes fewer than 10 cigarettes per day
You will not qualify if you...
- Pregnant or breastfeeding women
- Alcohol consumption exceeding 7 drinks per week
- Women using contraceptives for less than 3 months or hormone therapy for less than 6 months
- Taking medication for high cholesterol, diabetes, or hypertension
- Diagnosis of cardiovascular disease, diabetes, hypertension, or cancer
- Food allergies or aversions to foods in the study menus
- Currently on a diet or special diet
- Daytime ambulatory blood pressure above 150/90 mmHg
AI-Screening
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Trial Site Locations
Total: 1 location
1
Centre Nutrition, santé et société (NUTRISS), INAF, Université Laval
Québec, Quebec, Canada, G1V 0A6
Actively Recruiting
Research Team
B
Benoît Lamarche, PhD
CONTACT
I
Iris Gigleux, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
PREVENTION
Number of Arms
4
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