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

NCT06749327 | Not Yet Recruiting

• 1 other identifier: TBC
• Study Type: interventional
• Target: 330
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Cardiometabolic Risk Factors

Keywords

Plant-based diets; Diet quality; Cardiometabolic risk factors; Ultra-processed foods

Outcome Measures

Primary Outcomes (2)

• Glycated haemoglobin (HbA1C) (mmol/mol)

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

  Baseline and 4 months

• Total cholesterol (mg/dL)

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

  Baseline and 4 months

Secondary Outcomes (12)

• Anthropometric measure: Weight (kg)

  Baseline and 4 months

• Anthropometric measure: Height (m)

  Baseline and 4 months

• Anthropometric measure: Waist circumference (cm)

  Baseline and 4 months

• Anthropometric measure: Hip circumference (cm)

  Baseline and 4 months

• Blood pressure (mmHg)

  Baseline and 4 months

Study Arms (2)

High UPF, high hPDI diet

EXPERIMENTAL

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

Behavioral: High UPF, high hPDI diet

Low UPF, high hPDI diet

ACTIVE COMPARATOR

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

Behavioral: Low UPF, high hPDI diet

Interventions

High UPF, high hPDI diet BEHAVIORAL

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

High UPF, high hPDI diet

Low UPF, high hPDI diet BEHAVIORAL

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

Low UPF, high hPDI diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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 will be screened for their adherence to the Plant based diet Index (PDI ).
• Individuals with low adherence will enter run-in phase only (6 weeks)
• Individuals with high adherence will enter the main intervention (4 months)

Sponsors & Collaborators

• Queen's University, Belfast: lead
• University College Dublin: collaborator
• Harvard School of Public Health (HSPH): collaborator

Study Sites (2)

University College Dublin

Dublin, Ireland, D04 C1P1, Ireland

Location

Centre for Public Health, Queen's University Belfast

Belfast, Northern Ireland, BT12 6BJ, United Kingdom

Location

Study Officials

• Prof. Lorraine Brennan, PhD

  University College Dublin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Prof. Jayne Woodside, PhD

CONTACT

+4402890 978942; j.woodside@qub.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 27, 2024
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: May 18, 2026

Record last verified: 2026-05

Locations

IE (1); GB (1)