Use of nutritional advice to prevent cardiovascular disease in people with risk factors for cardiovascular disease Circulatory System
Conditions
Interventions
The aim of this study is to validate a metabolic profiling model constructed using data from a small study carried out in the months before this study (details of this study are included at the end of
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged between 30 and 65 years 2. At risk of CVD with at least three of the below criteria: 2.1. Body mass index of 20 - 35 kg/m² 2.2. Systolic BP >=140 mmHg or diastolic BP >=90 mmHg, or taking antihypertensive medication 2.3. LDL-cholesterol >= 4.14 mmol/l and HDL-cholesterol 102cm in men or > 88cm in women
Exclusion criteria
Exclusion criteria: 1. Have been involved in any other study during the 12 weeks 2. Weight change of >=3kg in the preceding 3 months 3. Substance abuse 4. Excess alcohol intake 5. Taken any dietary supplements in the last 6 months 6. Pregnancy 7. Diabetes 8. Cancer 9. Gastrointestinal disease e.g. inflammatory bowel disease or irritable bowel syndrome 10. Kidney disease 11. Liver disease 12. Pancreatitis 13. Any other chronic illness or being diagnosed with HIV 14. Use of medications likely to interfere with energy metabolism, appetite regulation and hormonal balance, including: anti inflammatory drugs or steroids, antibiotics, androgens, phenytoin, erythromycin or thyroid hormones Subjects with the above conditions would have an altered pattern of hormones and inflammatory molecules because of their disease process and would therefore give us confounding or misleading results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urinary and blood metabolic profiles measured from urine and blood samples using Nuclear Magnetic Resonance and Mass Spectrometry at baseline and then once every 2 weeks, for 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Dietary biomarkers present in urine, blood, faeces, and saliva samples measured at baseline and then once every 2 weeks, for 12 weeks using metabolic profiling analysis 2. Participants eating behaviour measured using 24-h food diary measured once every 2 weeks, for 12 weeks 3. C-reactive protein (CRP) measured at baseline and 12 weeks 4. HbA1c measured at baseline and 12 weeks 5. Blood pressure (mmHg) measured using a sphygmomanometer at baseline and then once every 2 weeks, for 12 weeks 6. BMI (kg/m²) at baseline and then once every 2 weeks, for 12 weeks 7. Waist circumference (cm) at baseline and then once every 2 weeks, for 12 weeks | — |
Countries
England, United Kingdom
Outcome results
None listed