Impact of Ultra-processed Foods on Cardiometabolic Risk Factors
NCT Number: NCT06538831
Acronym: NOVA
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cardiometabolic Risk
Interventions: OTHER: Diet N-P-|OTHER: Diet N+P-|OTHER: Diet N-P+|OTHER: Diet N+P+
Sponsor: Laval University
Collaborators: Canadian Institutes of Health Research (CIHR)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-09-01
Completion Date: 2028-08-31
Locations: Centre Nutrition, santé et société (NUTRISS), INAF, Université Laval, Quebec, G1V 0A6, Canada

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. We hypothesize:

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.

Primary Outcome Measures: Post treatment fasting LDL-C concentrations, Fasting serum LDL-C concentrations (mmol/L) will be measured at the end of the 6-wk intervention in all subjects in each group, on two consecutive days post-treatment. The mean of the two post-treatment values will be used in the analyses. Analyses will be adjusted for LDL-C concentrations values measured at baseline., 6 weeks|Post treatment insulin sensitivity (HOMA-IR), Insulin sensitivity (HOMA-IR) will be measured in the fasted state at the end of the 6-wk intervention in all subjects in each group, on two consecutive days post-treatment. The mean of the two post-treatment values will be used in the analyses. Analyses will be adjusted for insulin sensitivity (HOMA-IR) values measured in the fasted state at baseline., 6 weeks|Post treatment day-time ambulatory systolic blood pressure, Day-time ambulatory systolic blood pressure will be measured at the end of the 6-wk intervention in all subjects in each group. Analyses will be adjusted for day-time ambulatory systolic blood pressure values measured at baseline., 6 weeks
Secondary Outcome Measures: Post treatment fasting triglyceride, Fasting serum triglyceride (mmol/L) will be measured at the end of the 6-wk intervention in all subjects in each group, on two consecutive days post-treatment. The mean of the two post-treatment values will be used in the analyses. Analyses will be adjusted for triglyceride concentrations values measured at baseline., 6 weeks|Post treatment ApoB-100, Fasting serum ApoB-100 (mmol/L) will be measured at the end of the 6-wk intervention in all subjects in each group, on two consecutive days post-treatment. The mean of the two post-treatment values will be used in the analyses. Analyses will be adjusted for ApoB-100 concentrations values measured at baseline., 6 weeks|Post treatment HDL-C concentrations, Fasting serum HDL-C concentrations (mmol/L) will be measured at the end of the 6-wk intervention in all subjects in each group, on two consecutive days post-treatment. The mean of the two post-treatment values will be used in the analyses. Analyses will be adjusted for HDL-C concentrations values measured at baseline., 6 weeks|Post treatment fasting glucose concentrations, Fasting serum glucose concentrations (mmol/L) will be measured at the end of the 6-wk intervention in all subjects in each group, on two consecutive days post-treatment. The mean of the two post-treatment values will be used in the analyses. Analyses will be adjusted for glucose concentrations values measured at baseline., 6 weeks|Post treatment fasting insulin concentrations, Fasting serum insulin concentrations (mmol/L) will be measured at the end of the 6-wk intervention in all subjects in each group, on two consecutive days post-treatment. The mean of the two post-treatment values will be used in the analyses. Analyses will be adjusted for insulin concentrations values measured at baseline., 6 weeks|Post treatment day-time ambulatory diastolic blood pressure, Day-time ambulatory diastolic blood pressure will be measured at the end of the 6-wk intervention in all subjects in each group. Analyses will be adjusted for day-time ambulatory diastolic blood pressure values measured at baseline., 6 weeks|Post treatment 24-hr ambulatory systolic blood pressure, 24-hr ambulatory systolic blood pressure will be measured at the end of the 6-wk intervention in all subjects in each group. Analyses will be adjusted for 24-hr ambulatory systolic blood pressure values measured at baseline., 6 weeks|Post treatment 24-hr ambulatory diastolic blood pressure, 24-hr ambulatory diastolic blood pressure will be measured at the end of the 6-wk intervention in all subjects in each group. Analyses will be adjusted for 24-hr ambulatory diastolic blood pressure values measured at baseline., 6 weeks|On-treatment Diet palatability, These are exploratory analyses. Scales measuring diet palatability will be completed during the same three days of the 7-day cycling menu during the first and last week of the 6-wk intervention. The mean of all measurements will be used in the analyses., 6 weeks|On-treatment Perceived healthiness of meals, These are exploratory analyses. Scales measuring perceived healthiness of meals will be completed during the same three days of the 7-day cycling menu during the first and last week of the 6-wk intervention. The mean of all measurements will be used in the analyses., 6 weeks|On-treatment Hunger and fullness perceptions, These are exploratory analyses. Scales measuring hunger and fullness perceptions will be completed during the same three days of the 7-day cycling menu during the first and last week of the 6-wk intervention. The mean of all measurements will be used in the analyses., 6 weeks|Post-treatment Gut microbiota, These are exploratory analyses in a subset of participants only. Deep 16S rDNA metagenomic analysis in feces collected at week 6 will be used to characterize gut microbiota composition and function. Analyses will be adjusted for baseline values of gut microbiota composition and function measured on fecal samples collected at baseline., 6 weeks