N/A
N=149
The Efficacy of Individualized Dietary Advice in Improving Diet Quality and Cardiovascular Health
Cardiovascular Diseases
Bottom Line
View on ClinicalTrials.gov: NCT03854461 ↗Enrolled (actual)
149
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Difference in Mean Change in Prime Diet Quality Score Between Groups Between Months 0 and 6 — 1.22 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Personalised dietary advice and educational material (Behavioral); Educational material (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Queen's University, Belfast
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in Mean Change in Prime Diet Quality Score Between Groups Between Months 0 and 6 |
1.22 | — |
| SECONDARY Alcohol Consumption |
— | — |
| SECONDARY Medication Use |
— | — |
| SECONDARY Physical Activity |
— | — |
| SECONDARY Anthropometric Data - Weight |
— | — |
| SECONDARY Anthropometric Data - Waist to Hip Ratio |
— | — |
| SECONDARY Anthropometric Data - Height |
— | — |
| SECONDARY Anthropometric Data - Body Composition. |
— | — |
| SECONDARY Blood Pressure |
— | — |
| SECONDARY Biomarkers of Cardiometabolic Risk |
— | — |
| SECONDARY Biomarkers of Diet Quality |
— | — |
| SECONDARY Gut Microbiota Composition (Subset of Participants Only) |
— | — |
Summary
This study is a a randomized controlled parallel group dietary intervention conducted over six months in participants at high risk of cardiovascular disease living in Ireland (North and South) to evaluate the efficacy of individualized dietary advice incorporating biomarker profiles in improving diet quality and cardiometabolic outcomes.
Eligibility Criteria
Participants will be at high risk (>20% over 10 years) of developing CVD.
Inclusion Criteria
Participants will be considered eligible to enroll in the study if they are:
- overweight (BMI >27 and ≤ 45 kg/m2),
- have low Prime Diet Quality Score (PDQS 28 Units/week for men or >21 Units/week for women),
- have a low predicted likelihood to change dietary habits
- are unable to provide informed consent.
Data sourced from ClinicalTrials.gov (NCT03854461). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.