Milk Proteins, Ambulatory Blood Pressure and Vascular Function

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02090842
• Other study ID #: 12/40
• Status: Completed
• Phase: N/A
• First received: June 17, 2013
• Last updated: January 8, 2016
• Start date: February 2014
• Est. completion date: February 2015

Study information

• Verified date: January 2016
• Source: University of Reading
• Contact: n/a
• Is FDA regulated: No
• Health authority: University Research Ethics Committee, University of Reading: UK
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 77 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypertension

Intervention

Dietary Supplement:
• Ca-caseinate

• Maltodextrin

• Whey protein isolate

Locations

Country	Name	City	State
United Kingdom	Department of Food and Nutritional Sciences, University of Reading	Reading	Berks

Sponsors (2)

Lead Sponsor	Collaborator
University of Reading	Volac Int. Ltd.

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

Pal S, Ellis V. Acute effects of whey protein isolate on blood pressure, vascular function and inflammatory markers in overweight postmenopausal women. Br J Nutr. 2011 May;105(10):1512-9. doi: 10.1017/S0007114510005313. Epub 2011 Jan 28. — View Citation

Pal S, Ellis V. The chronic effects of whey proteins on blood pressure, vascular function, and inflammatory markers in overweight individuals. Obesity (Silver Spring). 2010 Jul;18(7):1354-9. doi: 10.1038/oby.2009.397. Epub 2009 Nov 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Handgrip strength measurement		Chronic study: Baseline and week 8 assessments for the two dietary intervention arms	No
Other	Metabonomics		Chronic study: Baseline and week 8 assessments for the two dietary intervention arms; Acute study: fasted and postprandial	No
Primary	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	No
Secondary	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	No
Secondary	Changes in plasma lipids		Chronic study: Baseline and week 8 assessments for the two dietary intervention arms, Acute study: fasted and postprandial	No
Secondary	Changes in markers of insulin resistance		Chronic study: Baseline and week 8 assessments for the two dietary intervention arms, Acute study: fasted and postprandial	No
Secondary	Changes in inflammatory markers		Chronic study: Baseline and week 8 assessments for the two dietary intervention arms, Acute study: fasted and postprandial	No
Secondary	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	No
Secondary	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	No