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RecruitingNot ApplicableNCT06538831

Impact of Ultra-processed Foods on Cardiometabolic Risk Factors

A 2x2 Factorial Randomized Controlled Trial to Elucidate How Ultra-processed Foods Modulate Cardiometabolic Risk

Sponsor

Laval University

Enrollment

120 participants

Start Date

Sep 25, 2024

Study Type

INTERVENTIONAL

Conditions

Cardiometabolic Risk

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 : 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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria6

  • 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 Criteria8

  • 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

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Interventions

OTHERDiet N-P-

Low in saturated fatty acids (SFAs), free sugar and sodium; Low in ultra-processed foods (UPFs)

OTHERDiet N+P-

Rich in SFAs, free sugar and sodium; Low in UPFs

OTHERDiet N-P+

Low in SFAs, free sugar and sodium; High in UPFs

OTHERDiet N+P+

Rich in SFAs, free sugar and sodium; High in UPFs

Locations(1)

Centre Nutrition, santé et société (NUTRISS), INAF, Université Laval

Québec, Quebec, Canada

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NCT06538831