Skip to main content
OpenTrials
Completed

NCT Number: NCT02090842

Milk Proteins, Ambulatory Blood Pressure and Vascular Function

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

30 year–77 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Food and Nutritional Sciences, University of Reading

Reading, Berks, RG6 6AP, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ca-caseinate

Dietary Supplement

Maltodextrin

Dietary Supplement

Whey protein isolate

Dietary Supplement

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Changes in plasma lipids

    Time frame: Chronic study: Baseline and week 8 assessments for the two dietary intervention arms, Acute study: fasted and postprandial

  3. 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

  4. Changes in inflammatory markers

    Time frame: Chronic study: Baseline and week 8 assessments for the two dietary intervention arms, Acute study: fasted and postprandial

  5. 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

  6. 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

Other outcomes

  1. Handgrip strength measurement

    Time frame: Chronic study: Baseline and week 8 assessments for the two dietary intervention arms

  2. Metabonomics

    Time frame: Chronic study: Baseline and week 8 assessments for the two dietary intervention arms; Acute study: fasted and postprandial

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Collaborators

  • Volac Int. Ltd.

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 18, 2014
Registry last updated
Jan 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.