Cardiometabolic RiskNOVANCT06538831
Impact of Ultra-processed Foods on Cardiometabolic Risk Factors
A study testing Diet N-P-, Diet N+P- and Diet N-P+ in people with Cardiometabolic Risk, run by Laval University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiometabolic Risk
- What is being tested?
- Diet N-P-, Diet N+P- and Diet N-P+
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 25 Sep 2024to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Centre Nutrition, santé et société (NUTRISS), INAF, Université Laval
Québec, Quebec, G1V 0A6
Benoît Lamarche, PhD, 418-656-3527, benoit.lamarche@fsaa.ulaval.ca
Iris Gigleux, MSc, 418-656-2131 ext. 405087, iris.gigleux@fsaa.ulaval.ca
About this study
Official title: A 2x2 Factorial Randomized Controlled Trial to Elucidate How Ultra-processed Foods Modulate Cardiometabolic Risk
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 :
- that the nutrient composition of UPFs (high SFA, free sugar and sodium) per se has deleterious impacts on cardiometabolic risk factors;
- 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.
Read the 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:
- A diet low in saturated fatty acids (SFAs), free sugar and sodium, with low ultra-processed foods (UPFs)
- A diet rich in SFAs, free sugar and sodium, with low UPFs;
- A diet low in SFAs, free sugar and sodium, with high levels of UPFs;
- 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).
- Conditions
- Cardiometabolic Risk
- Being tested
- Diet N-P-, Diet N+P-, Diet N-P+, Diet N+P+
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet N-P-Other
Low in saturated fatty acids (SFAs), free sugar and sodium; Low in ultra-processed foods (UPFs)
Diet N+P-Other
Rich in SFAs, free sugar and sodium; Low in UPFs
Diet N-P+Other
Low in SFAs, free sugar and sodium; High in UPFs
Diet N+P+Other
Rich in SFAs, free sugar and sodium; High in UPFs
| Study group | Role | What they receive |
|---|---|---|
| Diet N-P- | Experimental | Not described Receives: Other: Diet N-P- |
| Diet N+P- | Experimental | Not described Receives: Other: Diet N+P- |
| Diet N-P+ | Experimental | Not described Receives: Other: Diet N-P+ |
| Diet N+P+ | Experimental | Not described Receives: Other: Diet N+P+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 weeks
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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. Title of the scale: Main course evaluation.
Minimum and maximum values : 1 to 8 . Higher scores are not synonymous of better or worse results.
Measured: 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. 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.
Measured: 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.
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.
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start25 Sep 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiometabolic RiskStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Parallel group 2x2 factorial randomized controlled trial in fully controlled feeding conditions
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Benoit Lamarche, Laval University
- Investigators
- Benoît Lamarche, PhD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06538831
- Sponsor's protocol ID
- NUTRISS-NOVA-2024-219
- Acronym
- NOVA
- Status last verified
- Oct 2024
- First submitted
- 31 Jul 2024
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rochette M, Charest A, Gigleux I, Couture P, Provencher V, Lamarche B. How ultra-processed foods modulate cardiometabolic risk: A 2 x 2 factorial randomized controlled trial protocol in healthy adults. Contemp Clin Trials. 2026 Jun;165:108323. doi: 10.1016/j.cct.2026.108323. Epub 2026 Apr 20.
PubMed 42019675
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 2x2 Factorial Randomized Controlled Trial to Elucidate How Ultra-processed Foods Modulate Cardiometabolic Risk
- ClinicalTrials.gov ID
- NCT06538831
- Acronym / sponsor ID
- NOVA / NUTRISS-NOVA-2024-219
- Conditions
- Cardiometabolic Risk
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 25 Sep 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 6 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 :
- that the nutrient composition of UPFs (high SFA, free sugar and sodium) per se has deleterious impacts on cardiometabolic risk factors;
- 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:
- A diet low in saturated fatty acids (SFAs), free sugar and sodium, with low ultra-processed foods (UPFs)
- A diet rich in SFAs, free sugar and sodium, with low UPFs;
- A diet low in SFAs, free sugar and sodium, with high levels of UPFs;
- 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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Parallel group 2x2 factorial randomized controlled trial in fully controlled feeding conditions
| Arm | Type | Receives |
|---|---|---|
| Diet N-P- | Experimental | Other: Diet N-P- |
| Diet N+P- | Experimental | Other: Diet N+P- |
| Diet N-P+ | Experimental | Other: Diet N-P+ |
| Diet N+P+ | Experimental | Other: Diet N+P+ |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet N-P-Low in saturated fatty acids (SFAs), free sugar and sodium; Low in ultra-processed foods (UPFs) | Other | Diet N-P- |
| Diet N+P-Rich in SFAs, free sugar and sodium; Low in UPFs | Other | Diet N+P- |
| Diet N-P+Low in SFAs, free sugar and sodium; High in UPFs | Other | Diet N-P+ |
| Diet N+P+Rich in SFAs, free sugar and sodium; High in UPFs | Other | Diet N+P+ |
Primary outcome
Post treatment fasting LDL-C concentrations
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.
Post treatment insulin sensitivity (HOMA-IR)
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.
Post treatment day-time ambulatory systolic blood pressure
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.
12 secondary outcomes
Post treatment fasting triglyceride
Time frame: 6 weeks
Post treatment ApoB-100
Time frame: 6 weeks
Post treatment HDL-C concentrations
Time frame: 6 weeks
Post treatment fasting glucose concentrations
Time frame: 6 weeks
Post treatment fasting insulin concentrations
Time frame: 6 weeks
Post treatment day-time ambulatory diastolic blood pressure
Time frame: 6 weeks
Post treatment 24-hr ambulatory systolic blood pressure
Time frame: 6 weeks
Post treatment 24-hr ambulatory diastolic blood pressure
Time frame: 6 weeks
On-treatment Diet palatability
Time frame: 6 weeks
On-treatment Perceived healthiness of meals
Time frame: 6 weeks
On-treatment Hunger and fullness perceptions
Time frame: 6 weeks
Post-treatment Gut microbiota
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Derived from this study: PubMed 42019675Rochette M, Charest A, Gigleux I, Couture P, Provencher V, Lamarche B. How ultra-processed foods modulate cardiometabolic risk: A 2 x 2 factorial randomized controlled trial protocol in healthy adults. Contemp Clin Trials. 2026 Jun;165:108323. doi: 10.1016/j.cct.2026.108323. Epub 2026 Apr 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Benoît Lamarche, PhD principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet N-P-, Diet N+P- and Diet N-P+ in people with Cardiometabolic Risk, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benoît Lamarche, PhD (418-656-3527, benoit.lamarche@fsaa.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post treatment fasting LDL-C concentrations (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06538831, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024.