Health TrialsbyHealthPanel

Impact of Ultra-processed Foods on Cardiometabolic Risk Factors

ConditionCardiometabolic Risk
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorLaval University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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%

Disqualifiers

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

Trial design

Design model

Factorial

Treatments tested in this trial

  • Diet N-P-

    Other intervention

    Low in saturated fatty acids (SFAs), free sugar and sodium; Low in ultra-processed foods (UPFs)

  • Diet N+P-

    Other intervention

    Rich in SFAs, free sugar and sodium; Low in UPFs

  • Diet N-P+

    Other intervention

    Low in SFAs, free sugar and sodium; High in UPFs

  • Diet N+P+

    Other intervention

    Rich in SFAs, free sugar and sodium; High in UPFs

Treatment groups

120 Participants
are divided into 4 treatment groups
Group A: Diet N-P-Experimental treatment 1 intervention
Group B: Diet N+P-Experimental treatment 1 intervention
Group C: Diet N-P+Experimental treatment 1 intervention
Group D: Diet N+P+Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
6 weeks
2

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.

Time frame
6 weeks
3

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.

Time frame
6 weeks

Secondary outcomes

1

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.

Time frame
6 weeks
2

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.

Time frame
6 weeks
3

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.

Time frame
6 weeks
4

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.

Time frame
6 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Laval University

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

Source ClinicalTrials.gov
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