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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
High UPF, high hPDI diet
BehavioralHigh ultra-processed foods (UPFs) and healthy plant based diet
Low UPF, high hPDI diet
BehavioralLow ultra-processed foods (UPFs) and high healthy plant-based diet
Treatment groups
Trial outcomes
Primary outcomes
Glycated haemoglobin (HbA1C) (mmol/mol)
Change in HbA1c over the course of the 4 month intervention.
Total cholesterol (mg/dL)
Change in total cholesterol will be measured over the course of the 4 month intervention.
Secondary outcomes
Anthropometric measure: Weight (kg)
Weight (kg) measured using calibrated scales at baseline and 4 months
Anthropometric measure: Height (m)
Height (m) measured using stadiometer at baseline and 4 months.
Anthropometric measure: Waist circumference (cm)
Waist circumference (cm) measured at baseline and 4 months.
Anthropometric measure: Hip circumference (cm)
Hip circumference (cm) measured at baseline and 4 months.
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
This trial is not recruiting at the moment. You can still explore other options: