Milk Proteins, Ambulatory Blood Pressure and Vascular Function

January 8, 2016 updated by: Julie Lovegrove, University of Reading

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Berks
      • Reading, Berks, United Kingdom, RG6 6AP
        • Department of Food and Nutritional Sciences, University of Reading

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 77 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Whey protein isolate
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
EXPERIMENTAL: Ca-caseinate
Subjects are asked to supplement their habitual diet with 56 g of Ca-caseinate a day for 8 weeks.
Dietary supplement: Ca-caseinate
OTHER: Maltodextrin
Subjects are asked to supplement their habitual diet with 54 g of maltodextrin a day for 8 weeks.
Dietary supplement: Maltodextrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in 24-h ambulatory blood pressure
Time Frame: 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
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
Time Frame
Changes in vascular reactivity measured by flow-mediated dilation (FMD)
Time Frame: Chronic study: Baseline and week 8 assessments for the two dietary intervention arms, Acute study: determined at 0 (fasted), 180, 300, 420 min
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
Time Frame: Chronic study: Baseline and week 8 assessments for the two dietary intervention arms, Acute study: fasted and postprandial
Chronic study: Baseline and week 8 assessments for the two dietary intervention arms, Acute study: fasted and postprandial
Changes in markers of insulin resistance
Time Frame: Chronic study: Baseline and week 8 assessments for the two dietary intervention arms, Acute study: fasted and postprandial
Chronic study: Baseline and week 8 assessments for the two dietary intervention arms, Acute study: fasted and postprandial
Changes in inflammatory markers
Time Frame: Chronic study: Baseline and week 8 assessments for the two dietary intervention arms, Acute study: fasted and postprandial
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)
Time Frame: Chronic study: Baseline and week 8 assessments for the two dietary intervention arms, Acute study: determined at 0 (fasted), 180, 300, 420 min
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)
Time Frame: Chronic study: Baseline and week 8 assessments for the two dietary intervention arms, Acute study: determined at 0 (fasted), 180, 300, 420 min
Chronic study: Baseline and week 8 assessments for the two dietary intervention arms, Acute study: determined at 0 (fasted), 180, 300, 420 min

Other Outcome Measures

Outcome Measure
Time Frame
Handgrip strength measurement
Time Frame: Chronic study: Baseline and week 8 assessments for the two dietary intervention arms
Chronic study: Baseline and week 8 assessments for the two dietary intervention arms
Metabonomics
Time Frame: Chronic study: Baseline and week 8 assessments for the two dietary intervention arms; Acute study: fasted and postprandial
Chronic study: Baseline and week 8 assessments for the two dietary intervention arms; Acute study: fasted and postprandial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Reading

Collaborators

Volac Int. Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (ACTUAL)

February 1, 2015

Study Completion (ACTUAL)

February 1, 2015

Study Registration Dates

First Submitted

June 17, 2013

First Submitted That Met QC Criteria

March 14, 2014

First Posted (ESTIMATE)

March 18, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

January 11, 2016

Last Update Submitted That Met QC Criteria

January 8, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12/40

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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