Clinical trial NCT06538831: Impact of Ultra-processed Foods on Cardiometabolic Risk Factors
Official title: A 2x2 Factorial Randomized Controlled Trial to Elucidate How Ultra-processed Foods Modulate Cardiometabolic Risk
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiometabolic Risk
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2024-08-06
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Parallel group 2x2 factorial randomized controlled trial in fully controlled feeding conditions
Primary purpose: PREVENTION

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.

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Post treatment fasting LDL-C concentrations
timeFrame: 6 weeks
measure: Post treatment insulin sensitivity (HOMA-IR)
timeFrame: 6 weeks
measure: Post treatment day-time ambulatory systolic blood pressure
timeFrame: 6 weeks
Secondary outcomes:
measure: Post treatment fasting triglyceride
timeFrame: 6 weeks
measure: Post treatment ApoB-100
timeFrame: 6 weeks
measure: Post treatment HDL-C concentrations
timeFrame: 6 weeks
measure: Post treatment fasting glucose concentrations
timeFrame: 6 weeks
measure: Post treatment fasting insulin concentrations
timeFrame: 6 weeks
measure: Post treatment day-time ambulatory diastolic blood pressure
timeFrame: 6 weeks
measure: Post treatment 24-hr ambulatory systolic blood pressure
timeFrame: 6 weeks
measure: Post treatment 24-hr ambulatory diastolic blood pressure
timeFrame: 6 weeks
measure: On-treatment Diet palatability
timeFrame: 6 weeks
measure: On-treatment Perceived healthiness of meals
timeFrame: 6 weeks
measure: On-treatment Hunger and fullness perceptions
timeFrame: 6 weeks
measure: Post-treatment Gut microbiota
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Centre Nutrition, santé et société (NUTRISS), INAF, Université Laval
Study officials:
affiliation: Laval University
name: Benoît Lamarche, PhD
role: PRINCIPAL_INVESTIGATOR
References: