Impact of Ultra-processed Foods on Cardiometabolic Risk Factors

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:

1. A diet low in saturated fatty acids (SFAs), free sugar and sodium, with low ultra-processed foods (UPFs) 2. A diet rich in SFAs, free sugar and sodium, with low UPFs; 3. A diet low in SFAs, free sugar and sodium, with high levels of UPFs; 4. A diet rich in SFAs, free sugar and sodium, with high levels of UPFs.

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).

• Post treatment fasting triglyceride [Срок оценки: 6 weeks]
• Post treatment ApoB-100 [Срок оценки: 6 weeks]
• Post treatment HDL-C concentrations [Срок оценки: 6 weeks]
• Post treatment fasting glucose concentrations [Срок оценки: 6 weeks]
• Post treatment fasting insulin concentrations [Срок оценки: 6 weeks]
• Post treatment day-time ambulatory diastolic blood pressure [Срок оценки: 6 weeks]
• Post treatment 24-hr ambulatory systolic blood pressure [Срок оценки: 6 weeks]
• Post treatment 24-hr ambulatory diastolic blood pressure [Срок оценки: 6 weeks]
• On-treatment Diet palatability [Срок оценки: 6 weeks]
• On-treatment Perceived healthiness of meals [Срок оценки: 6 weeks]
• On-treatment Hunger and fullness perceptions [Срок оценки: 6 weeks]
• Post-treatment Gut microbiota [Срок оценки: 6 weeks]