Recruiting

Observational Study

Sponsor:

Laval University

Code:

NCT06538831

Conditions

Cardiometabolic Risk

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Diet N-P-

Diet N+P-

Diet N-P+

Diet N+P+

Study Details

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 :

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

Cardiometabolic Risk

Study ID

NCT06538831

Start date

Sep 25, 2024

Status verified date

Oct, 2024

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Diet N-P-

experimental: Diet N+P-

experimental: Diet N-P+

experimental: Diet N+P+

Interventions

Diet N-P-

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

Diet N+P-

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

Diet N-P+

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

Diet N+P+

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

Primary outcome measure

  • Post treatment fasting LDL-C concentrations [ Time Frame: 6 weeks ]
  • Post treatment insulin sensitivity (HOMA-IR) [ Time Frame: 6 weeks ]
  • Post treatment day-time ambulatory systolic blood pressure [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Benoît Lamarche, PhD

418-656-3527benoit.lamarche@fsaa.ulaval.ca

Iris Gigleux, MSc

418-656-2131Iris.Gigleux@fsaa.ulaval.ca

Locations

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

Recruiting

Quebec, Canada, G1V 0A6

Contacts

Benoît Lamarche, PhD

418-656-3527benoit.lamarche@fsaa.ulaval.ca

Iris Gigleux, MSc

418-656-2131iris.gigleux@fsaa.ulaval.ca

More Information

Sponsor

Laval University

Last update posted

Oct 17, 2024

Last verified

Oct, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Laval University on 2024-10-17.