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| Name | Class |
|---|---|
| University College Dublin | OTHER |
| Harvard School of Public Health (HSPH) | OTHER |
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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.
Controversy remains around the role of 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 study aims to isolate the health effects of food processing from those of diet quality through the conduct of a dietary intervention study.
To isolate the health effects of food processing, the investigators propose to use healthy plant-based diets as the "base" diet. The investigators propose to initially discover plasma metabolomic features responsive to improved hPDI adherence and then conduct a dietary intervention trial to evaluate the impact of UPF consumption, in the setting of a high hPDI diet, on cardiometabolic outcomes and metabolic pathways.
The study will consist of a run-in phase where participants with a low adherence to a plant based diet will be randomized into (1) an intervention group that will receive diet counselling to follow a high hPDI diet over a period of 6 weeks and (2) a control group that will consume their usual diet (low hPDI). Both arms will be advised to avoid ultra processed food (UPF) consumption. Assuming 15% attrition, the study will enrol 118 participants for the run-in phase. Individuals with a high adherence to plant based diet will follow their normal diet for the 6 weeks of this run-in phase and then will be randomised into the main 4 month study.
In the main four month study, a randomized controlled parallel group dietary intervention will be conducted in participants with high hPDI in Ireland (North and South) to evaluate the impact of UPF consumption, in the context of a high hPDI diet, on cardiometabolic outcomes such as glycated haemoglobin and total cholesterol, and metabolic pathways. Participants will be randomized into one of 2 groups: high UPF hPDI diet or low UPF hPDI diet. Assuming an attrition rate of 15%, the study will enrol ~212 individuals to achieve a sample size of 180 participants who will complete the trial.
Randomization will be performed using a randomization scheme generated using www.randomization.com with random block sizes by research staff independent of the study. The investigators will stratify randomization according to age and BMI.
Power calculation : Assuming a change in total cholesterol of 9 mg/dL at four months and assuming a SD of change of 20, a total of 78 participants in each group is needed. Allowing for participant dropout of 15%, which is similar to that observed in the investigator's previous interventions, gives an overall sample size of 180.
Based on an SD of difference in change in HbA1c of 0.3%, the same sample size could detect as statistically significant a difference in HBA1c of 0.15% between the two intervention groups at four months.
The total number of participants that will be enrolled will be 330: 118 (run-in phase) and 212 (4 month trial).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High UPF, high hPDI diet | Experimental | High ultra-processed foods (UPFs) and healthy plant based diet |
|
| Low UPF, high hPDI diet | Active Comparator | Low ultra-processed foods (UPFs) and high healthy plant-based diet |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High UPF, high hPDI diet | Behavioral | High ultra-processed foods (UPFs) and healthy plant based diet |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Anthropometric measure: Weight (kg) | Weight (kg) measured using calibrated scales at baseline and 4 months | Baseline and 4 months |
| Anthropometric measure: Height (m) | Height (m) measured using stadiometer at baseline and 4 months. |
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Inclusion Criteria:
Exclusion Criteria:
Individuals will be screened for their adherence to the Plant based diet Index (PDI ).
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Prof. Jayne Woodside, PhD | Contact | +4402890 978942 | j.woodside@qub.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Prof. Lorraine Brennan, PhD | University College Dublin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University College Dublin | Dublin | Ireland | D04 C1P1 | Ireland |
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| Low UPF, high hPDI diet | Behavioral | Low ultra-processed foods (UPFs) and high healthy plant-based diet |
|
| Baseline and 4 months |
| Anthropometric measure: Waist circumference (cm) | Waist circumference (cm) measured at baseline and 4 months. | Baseline and 4 months |
| Anthropometric measure: Hip circumference (cm) | Hip circumference (cm) measured at baseline and 4 months. | Baseline and 4 months |
| Blood pressure (mmHg) | Blood pressure will be measured twice from the right arm, using an automated Omron sphygmomanometer, with the participant sitting quietly for at least five minutes in advance | Baseline and 4 months |
| Dietary assessment | 2x 24-hour dietary recalls | Baseline and 4 months |
| Physical activity | Questionnaire/objective physical activity monitor. Higher scores in both questionnaire and physical activity monitor will indicate improved outcome. | Baseline and 4 months |
| Demographic/lifestyle information | E.g. alcohol use, medication use. | Baseline and 4 months |
| Continuous Glucose Monitoring (mmol/L) | Continuous glucose monitoring (mmol/L) at baseline and 4 months | Baseline and 4 months |
| Plasma metabolome | Fasting blood samples will be drawn from the antecubital vein and immediately separated into plasma. | Pre and post run-in phase (6 week run-in) ; baseline and 4 months (main trial) |
| Gut microbiome | Stool samples will be collected at home within 24 h of the study visit and brought to the laboratory for storage. Samples will be profiled for gut microbiota composition and functional potentials. | Baseline and 4 months |
| Inflammatory markers e.g. CRP (mg/L) | Changes in inflammatory markers such as CRP (mg/L) over the course of the 4 month intervention | Baseline and 4 months |
| Centre for Public Health, Queen's University Belfast | Belfast | Northern Ireland | BT12 6BJ | United Kingdom |
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