Hypertension
Conditions
Keywords
Milk proteins, Blood pressure, Vascular function
Brief summary
Epidemiological studies demonstrated an inverse associations between cardiovascular events and milk and dairy product consumption. Evidence from human intervention studies suggests that both whey and casein may be effective in blood pressure-lowering, however there is limited data on the impact of milk proteins on vascular function. This research aims to compare the potential acute and chronic impacts of the two main milk proteins (whey and casein) with maltodextrin on blood pressure and vascular function. Furthermore, the effects of these proteins on the markers of insulin resistance, lipid metabolism and inflammatory status will also be investigated in 'at-risk' individuals. This research includes both an acute and chronic intervention study which have been independently powered on the appropriate outcome measures. This has generated different sample size requirements for the two studies (Actual participants on the acute study: n=27, and on the chronic study: n=38).
Interventions
Sponsors
Volac Int. Ltd.
University of Reading
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 77 Years
Healthy volunteers
Yes
Inclusion criteria
* A signed consent form * Blood pressure: 120/80-159/99 * Age: 30-77 years * BMI 20-40 kg/m2 * Glucose \<7 mmol/l (Not diagnosed with diabetes) * Chol \<8 mmol/l * TAG \<4 mmol/l * Normal liver and kidney function * Haemoglobin (\>110 g/dl women; 140g/dl men)
Exclusion criteria
* Milk allergy, lactose allergy * Coeliac disease * Renal, gastrointestinal, respiratory, endocrine, liver disease or cancer * Surgery in the previous 6 months * Secondary hypertension * Excess alcohol consumption (drinking \>28 unit/wk man; \>21 unit/wk women) * Smoker * Vegan * Taking nutritional supplementation (e.g. fish oil, proteins) * Anaemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in 24-h ambulatory blood pressure | Chronic study: Baseline and week 8 assessments for the three dietary intervention arms, Acute study: automated ambulatory blood monitor measures every 15 minutes for 3 hours after both meals, then every 30 minutes for day |
Secondary
| Measure | Time frame |
|---|---|
| Changes in vascular reactivity measured by flow-mediated dilation (FMD) | Chronic study: Baseline and week 8 assessments for the two dietary intervention arms, Acute study: determined at 0 (fasted), 180, 300, 420 min |
| Changes in plasma lipids | Chronic study: Baseline and week 8 assessments for the two dietary intervention arms, Acute study: fasted and postprandial |
| Changes in markers of insulin resistance | Chronic study: Baseline and week 8 assessments for the two dietary intervention arms, Acute study: fasted and postprandial |
| Changes in arterial stiffness measured by pulse wave analysis (PWA) | Chronic study: Baseline and week 8 assessments for the two dietary intervention arms, Acute study: determined at 0 (fasted), 180, 300, 420 min |
| Changes in arterial stiffness measured by digital volume pulse (DVP) | Chronic study: Baseline and week 8 assessments for the two dietary intervention arms, Acute study: determined at 0 (fasted), 180, 300, 420 min |
| Changes in inflammatory markers | Chronic study: Baseline and week 8 assessments for the two dietary intervention arms, Acute study: fasted and postprandial |
Other
| Measure | Time frame |
|---|---|
| Handgrip strength measurement | Chronic study: Baseline and week 8 assessments for the two dietary intervention arms |
| Metabonomics | Chronic study: Baseline and week 8 assessments for the two dietary intervention arms; Acute study: fasted and postprandial |
Countries
United Kingdom
Outcome results
None listed