Dissecting the Roles of High-quality Diets and Ultra Processed Foods on Cardiometabolic Health

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorQueen's University, Belfast

About this trial

Controversy remains around the role of ultra-processed food (UPF) consumption and health outcomes. A key question that remains to be answered is: when diet quality is the same, does food processing itself have any independent health effects? The current application aims to isolate the health effects of food processing from those of diet quality through the conduct of a dietary intervention study.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Men and women aged between 18 and 65 years in general good health with BMI < 35 kg/m2 who can provide informed consent.

Disqualifiers

Participants will be ineligible to enrol if they have diabetes, CVD, any type of cancer (except for basal cell skin cancer), or a condition (pregnancy, breastfeeding, etc) or dietary restriction(s) that would substantially limit their ability to complete the study.

Individuals with low adherence will enter run-in phase only (6 weeks)

Individuals with high adherence will enter the main intervention (4 months)

Trial design

Design model

Parallel

Treatments tested in this trial

  • High UPF, high hPDI diet

    Behavioral

    High ultra-processed foods (UPFs) and healthy plant based diet

  • Low UPF, high hPDI diet

    Behavioral

    Low ultra-processed foods (UPFs) and high healthy plant-based diet

Treatment groups

330 Participants
are divided into 2 treatment groups
Group A: High UPF, high hPDI dietExperimental treatment 1 intervention
Group B: Low UPF, high hPDI dietActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Glycated haemoglobin (HbA1C) (mmol/mol)

Change in HbA1c over the course of the 4 month intervention.

Time frame
Baseline and 4 months
2

Total cholesterol (mg/dL)

Change in total cholesterol will be measured over the course of the 4 month intervention.

Time frame
Baseline and 4 months

Secondary outcomes

1

Anthropometric measure: Weight (kg)

Weight (kg) measured using calibrated scales at baseline and 4 months

Time frame
Baseline and 4 months
2

Anthropometric measure: Height (m)

Height (m) measured using stadiometer at baseline and 4 months.

Time frame
Baseline and 4 months
3

Anthropometric measure: Waist circumference (cm)

Waist circumference (cm) measured at baseline and 4 months.

Time frame
Baseline and 4 months
4

Anthropometric measure: Hip circumference (cm)

Hip circumference (cm) measured at baseline and 4 months.

Time frame
Baseline and 4 months

Other outcomes

Sponsors and contacts

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

Queen's University, Belfast

Lead sponsor

University College Dublin

Collaborator

Harvard School of Public Health (HSPH)

Collaborator

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