Milk Proteins, Ambulatory Blood Pressure and Vascular Function

Study Overview
=================
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).

Official Title
-----------------
Investigating the Acute and Chronic Effects of Dietary Proteins on Markers of Vascular Function, Ambulatory Blood Pressure, Insulin Resistance and Lipid Metabolism.

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Dietary Supplement: Ca-caseinate
* Dietary Supplement: Maltodextrin
* Dietary Supplement: Whey protein isolate


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 77 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Whey protein isolate<br>Subjects are asked to supplement their habitual diet with 56 g of whey protein isolate a day for 8 weeks. | Dietary Supplement: Whey protein isolate<br> <br> |
| Experimental: Ca-caseinate<br>Subjects are asked to supplement their habitual diet with 56 g of Ca-caseinate a day for 8 weeks. | Dietary Supplement: Ca-caseinate<br> <br> |
| Other: Maltodextrin<br>Subjects are asked to supplement their habitual diet with 54 g of maltodextrin a day for 8 weeks. | Dietary Supplement: Maltodextrin<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 inflammatory markers |  | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Milk proteins, Blood pressure, Vascular function