Milk Proteins, Ambulatory Blood Pressure and Vascular Function

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Dietary Supplement: Whey protein isolate; Dietary Supplement: Ca-caseinate; Dietary Supplement: Maltodextrin

• Registration Number: NCT02090842
• Lead Sponsor: University of Reading

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-17
• Study Start: 2014-02
• Study First Submitted QC: 2014-03-14
• Study First Posted: 2014-03-18
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-08
• Last Update Posted: 2016-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Whey protein isolate	Whey protein isolate	Subjects are asked to supplement their habitual diet with 56 g of whey protein isolate a day for 8 weeks.
Ca-caseinate	Ca-caseinate	Subjects are asked to supplement their habitual diet with 56 g of Ca-caseinate a day for 8 weeks.
Maltodextrin	Maltodextrin	Subjects are asked to supplement their habitual diet with 54 g of maltodextrin a day for 8 weeks.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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
Changes in markers of insulin resistance	Chronic study: Baseline and week 8 assessments for the two dietary intervention arms, Acute study: fasted and postprandial

Trial Locations

Locations (1)

Department of Food and Nutritional Sciences, University of Reading; 🇬🇧 Reading, Berks, United Kingdom