Milk Proteins, Ambulatory Blood Pressure and Vascular Function

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Reading
Sponsor:
Collaborator:
Volac Int. Ltd.
Information provided by (Responsible Party):
Julie Lovegrove, University of Reading
ClinicalTrials.gov Identifier:
NCT02090842
First received: June 17, 2013
Last updated: March 14, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Hypertension
Dietary Supplement: Ca-caseinate
Dietary Supplement: Maltodextrin
Dietary Supplement: Whey protein isolate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Investigating the Acute and Chronic Effects of Dietary Proteins on Markers of Vascular Function, Ambulatory Blood Pressure, Insulin Resistance and Lipid Metabolism.

Resource links provided by NLM:


Further study details as provided by University of Reading:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Changes in plasma lipids [ Time Frame: Chronic study: Baseline and week 8 assessments for the two dietary intervention arms, Acute study: fasted and postprandial ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Changes in inflammatory markers [ Time Frame: Chronic study: Baseline and week 8 assessments for the two dietary intervention arms, Acute study: fasted and postprandial ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Handgrip strength measurement [ Time Frame: Chronic study: Baseline and week 8 assessments for the two dietary intervention arms ] [ Designated as safety issue: No ]
  • Metabonomics [ Time Frame: Chronic study: Baseline and week 8 assessments for the two dietary intervention arms; Acute study: fasted and postprandial ] [ Designated as safety issue: No ]

Estimated Enrollment: 42
Study Start Date: February 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Maltodextrin
Subjects are asked to supplement their habitual diet with 54 g of maltodextrin a day for 8 weeks.
Dietary Supplement: Maltodextrin

  Eligibility

Ages Eligible for Study:   30 Years to 77 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02090842

Contacts
Contact: Julie A. Lovegrove 0044(0)1183786418 ext 6418 j.a.lovegrove@reading.ac.uk
Contact: Ágnes A. Fekete a.a.fekete@pgr.reading.ac.uk

Locations
United Kingdom
Department of Food and Nutritional Sciences, University of Reading Recruiting
Reading, Berks, United Kingdom, RG6 6AP
Sponsors and Collaborators
University of Reading
Volac Int. Ltd.
Investigators
Principal Investigator: Julie A. Lovegrove, BSc, PhD, RNutr University of Reading
  More Information

Publications:
Responsible Party: Julie Lovegrove, Professor, University of Reading
ClinicalTrials.gov Identifier: NCT02090842     History of Changes
Other Study ID Numbers: 12/40
Study First Received: June 17, 2013
Last Updated: March 14, 2014
Health Authority: University Research Ethics Committee, University of Reading: UK

Keywords provided by University of Reading:
Milk proteins
Blood pressure
Vascular function

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014