Cardiovascular disease and type 2 diabetes disease prevention Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes mellitus
Conditions
Interventions
Participants will be randomly allocated to one of three groups:
1. Minimal Mediterranean diet intervention (Control) group will receive written advice on one occasion about the compone
total n=25)
Sponsors
Queen's University Belfast (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Cardiovascular disease (CVD) risk of >=20% over 10 years as defined by Joint British Societies? Guidelines on prevention of cardiovascular disease in clinical practice. The new Joint British Societies? CVD risk prediction charts, which can be used to estimate total risk of developing CVD over 10 years, are based on age, sex, smoking habit, systolic blood pressure and the ratio of total cholesterol to HDL cholesterol 2. Aged 40 years or over 3. Mediterranean Diet Score (MDS) = 3 4. Body Mass Index (BMI) > 27 and < 40
Exclusion criteria
Exclusion criteria: 1. Diabetes mellitus 2. Established cardiovascular disease of any kind 3. Surgery within previous three months 4. Psychiatric problems 5. Pregnant or lactating 6. Excessive alcohol consumption 7. Taking high-dose nutritional supplements 8. Medical conditions or dietary restrictions/allergies that would substantially limit ability to complete the study requirements 9. Low predicted likelihood to change dietary habits 10. Inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the habitual Mediterranean Diet Score (MDS) at 6 months from baseline (i.e. adoption of dietary change) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change at 6 months from baseline in biochemical markers of nutritional status related to Mediterranean diet (adoption of Mediterranean diet) (including HDL cholesterol, carotenoids, Vitamin C, Vitamin E and fatty acids) 2. Change in Mediterranean Diet Score at 12 months (end of intervention) from 6 months i.e. maintenance of Mediterranean diet 3. Change at 12 months from 6 months in Mediterranean Diet Score and biochemical markers of nutritional status (maintenance of dietary change) 4. Change in markers of overall nutritional status, CVD risk and type 2 diabetes mellitus (T2DM) risk 5. Change in psychosocial status including health and dietary related quality of life 6. Evaluation of factors related to feasibility and fidelity of the pilot study including intervention delivery, participant engagement and participation, attrition and reasons for withdrawal from the study | — |
Countries
Northern Ireland, United Kingdom
Outcome results
None listed