Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
Healthy Volunteers
NCT06538831

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

Age: 18Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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Impact of Ultra-processed Foods on Cardiometabolic Risk Factors | DecenTrialz