NCT06538831

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. 1.that the nutrient composition of UPFs (high SFA, free sugar and sodium) per se has deleterious impacts on cardiometabolic risk factors;
  2. 2.that the industrial techniques and processes of UPFs per se do not.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
28mo left

Started Sep 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress41%
Sep 2024Aug 2028

First Submitted

Initial submission to the registry

July 31, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 6, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

September 25, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2028

Last Updated

October 17, 2024

Status Verified

October 1, 2024

Enrollment Period

2.8 years

First QC Date

July 31, 2024

Last Update Submit

October 15, 2024

Conditions

Cardiometabolic Risk

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    6 weeks

Secondary Outcomes (12)

  • Post treatment fasting triglyceride

    6 weeks

  • Post treatment ApoB-100

    6 weeks

  • Post treatment HDL-C concentrations

    6 weeks

  • Post treatment fasting glucose concentrations

    6 weeks

  • Post treatment fasting insulin concentrations

    6 weeks

  • +7 more secondary outcomes

Study Arms (4)

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+

Interventions

Diet N+P+OTHER

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

Diet N+P+

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Nutrition, santé et société (NUTRISS), INAF, Université Laval

Québec, Quebec, G1V 0A6, Canada

RECRUITING

Study Officials

  • Benoît Lamarche, PhD

    Laval University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Benoît Lamarche, PhD

CONTACT

418-656-3527benoit.lamarche@fsaa.ulaval.ca

Iris Gigleux, MSc

CONTACT

418-656-2131Iris.Gigleux@fsaa.ulaval.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: Parallel group 2x2 factorial randomized controlled trial in fully controlled feeding conditions
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study director

Study Record Dates

First Submitted

July 31, 2024

First Posted

August 6, 2024

Study Start

September 25, 2024

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

August 31, 2028

Last Updated

October 17, 2024

Record last verified: 2024-10

Locations

CA(1)