Cardiovascular disease risk Circulatory System Cardiovascular disease, unspecified
Conditions
Interventions
Current interventions as of 18/02/2013:
At baseline subjects will be given sachets of a malted milk drink containing 24mcg vitamin D2, or placebo (malted milk drink without vitamin D a
Sponsors
King's College London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants will be healthy men or post-menopausal women aged between 50 and 70 years. A fasting blood sample will be collected to determine normal liver function, blood glucose and haematology.
Exclusion criteria
Exclusion criteria: 1. A reported history of angina pectoris, myocardial infarction, stroke, peripheral vascular disease, arterial fibrillation, congenital heart defects or congenital heart disease (this will be assessed using the telephone questionnaire and confirmed with the lifestyle questionnaire completed at screening) 2. An overall risk of cardiovascular disease over the next ten years of >20% assessed according to QRISK2 (www.qrisk.org) 2.Ambulatory blood pressure >150/95 mm Hg (assessed by ambulatory blood pressure monitoring) 3. Current use of medication for lowering blood cholesterol (statins) or blood pressure 4. Type 1 or Type 2 diabetes mellitus (fasting blood glucose > 7.0 mmol/L) 5. Chronic renal, liver or inflammatory bowel disease 6. Current cigarette smoker 7. Underweight or morbidly obese (Body Mass Index 35 kg/m2) 8. Prolonged exposure to high UV-b light since Nov 2011 9. Going to a lower latitude country, or using a tanning sunbed during the study period 10. Intolerance to study product (lactose, milk protein) 11. Taking vitamin and mineral supplements (including cod-liver oil), or prescription calcium/vitamin D 12. Unwilling to restrict consumption of oily fish to no more than 2 portions per week 13. Consuming soya milk 14. Unwilling to follow the protocol and/or give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Endothelial function as measured by flow mediated dilatation (FMD). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Cardiovascular risk profile (arterial stiffness measured by Pulse Wave Velocity (PWV) using a cuff on the upper arm and thigh, and Doppler probe on the neck, ambulatory blood pressure as measured by ambulatory blood pressure monitoring (ABP), fasting lipid profile, C - reactive protein as an indicator of low grade inflammation, MMP-9 and fibrinogen). 2. Markers of compliance ? Ca2+ , PTH, 25(OH)D2 and 25(OH)D3 concentrations and BMI. 3. We will use the Homeostasis Model Assessment (HOMA) to estimate beta cell function and insulin sensitivity based on measurements of c-peptide and fasting glucose. 4. As it has been suggested that vitamin D supplementation suppresses renin secretion, we shall measure plasma renin concentrations. 5. We will also measure cognitive function using a series of computerised questions. | — |
Countries
United Kingdom
Outcome results
None listed