NCT Number: NCT06538831
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Québec, Quebec, G1V 0A6, Canada
Location status: Recruiting
Benoît Lamarche, PhD
CONTACT
Benoît Lamarche, PhD
CONTACT
Iris Gigleux, MSc
CONTACT
418-656-2131 ext. 405087
This study is a parallel group 2x2 factorial randomized controlled trial, in which diet is fully controlled. A total of 120 men and women covering a broad range of adiposity and cardiometabolic risk factors will be randomly assigned to one of four 6-week experimental diets:
All foods in this full-feeding trial will be managed or prepared by food technicians at the Clinical Investigation Unit of our research center. A cyclic seven-day menu plan will be developed with similar foods across the four diets. Classifications of the degree of food processing will be made using NOVA classification. NOVA identifies four categories of foods based on the degree of food processing: 1- Unprocessed or minimally processed foods, 2- Processed Culinary Ingredients, 3- Processed Food and 4- Ultra-processed foods (UPFs). The two diets high in UPFs will predominantly feature commercially-bought foods classified as NOVA-4, while the two diets low in UPFs diets will predominantly include foods prepared in our metabolic kitchen (NOVA 1 to 3). Diets will be provided under isocaloric conditions to maintain body weight constant. The breakfast meal will represent approximately 30% of the daily energy intake in each diet, whereas the lunch and dinner meals each will provide about 35% of daily energy intake. Participants will have to come to the research center 3 to 5 times a week during the 6-week intervention to collect their meals and be weighed. Primary and secondary outcomes will be measured at the beginning and at the end of the 6-wk diet intervention.
The specifics objectives of this 2x2 factorial RCT are:
Obj 1: To assess the impact of the nutrient composition of UPFs on cardiometabolic risk, independent of variations in industrial techniques and processes (factor 1).
Obj 2: To assess the impact of industrial techniques and processes of UPFs on cardiometabolic risk, independent of variations in nutrient composition (factor 2).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Low in saturated fatty acids (SFAs), free sugar and sodium; Low in ultra-processed foods (UPFs)
Rich in SFAs, free sugar and sodium; Low in UPFs
Low in SFAs, free sugar and sodium; High in UPFs
Rich in SFAs, free sugar and sodium; High in UPFs
Time frame: 6 weeks
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.
Time frame: 6 weeks
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.
Time frame: 6 weeks
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.
Time frame: 6 weeks
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.
Time frame: 6 weeks
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.
Time frame: 6 weeks
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.
Time frame: 6 weeks
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.
Time frame: 6 weeks
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.
Time frame: 6 weeks
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.
Time frame: 6 weeks
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.
Time frame: 6 weeks
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.
Time frame: 6 weeks
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. Title of the scale: Main course evaluation.
Minimum and maximum values : 1 to 8 . Higher scores are not synonymous of better or worse results.
Time frame: 6 weeks
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. Title of the scale: Opinion on your main course. Minimum and maximum values : 1 to 8 . Higher scores are not synonymous of better or worse results.
Time frame: 6 weeks
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.
Title of the scale: Visual Analogue Scale - How hungry do you feel? Minimum and maximum values : Not hungry at all to very hungry. Higher scores are not synonymous with better or worse results.
Title of the scale: Visual Analogue Scale - How full do you feel? Minimum and maximum values : Not at all full to very full. Higher scores are not synonymous of better or worse results.
Time frame: 6 weeks
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.
Contact information is provided by the study sponsor or research team.
Laval University
Other
A 2x2 Factorial Randomized Controlled Trial to Elucidate How Ultra-processed Foods Modulate Cardiometabolic Risk
Acronym: NOVA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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