Milk Proteins, Ambulatory Blood Pressure and Vascular Function

NCT ID: NCT02090842

Last Updated: 2016-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-02-28

Brief Summary

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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

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Whey protein isolate

Subjects are asked to supplement their habitual diet with 56 g of whey protein isolate a day for 8 weeks.

Group Type EXPERIMENTAL

Whey protein isolate

Intervention Type DIETARY_SUPPLEMENT

Ca-caseinate

Subjects are asked to supplement their habitual diet with 56 g of Ca-caseinate a day for 8 weeks.

Group Type EXPERIMENTAL

Ca-caseinate

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin

Subjects are asked to supplement their habitual diet with 54 g of maltodextrin a day for 8 weeks.

Group Type OTHER

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Ca-caseinate

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

Whey protein isolate

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

77 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Volac Int. Ltd.

UNKNOWN

Sponsor Role collaborator

University of Reading

OTHER

Sponsor Role lead

Responsible Party

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Julie Lovegrove

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Julie A. Lovegrove, BSc, PhD, RNutr

Role: PRINCIPAL_INVESTIGATOR

University of Reading

Locations

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Department of Food and Nutritional Sciences, University of Reading

Reading, Berks, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 21272399 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19893505 (View on PubMed)

Fekete AA, Giromini C, Chatzidiakou Y, Givens DI, Lovegrove JA. Whey protein lowers blood pressure and improves endothelial function and lipid biomarkers in adults with prehypertension and mild hypertension: results from the chronic Whey2Go randomized controlled trial. Am J Clin Nutr. 2016 Dec;104(6):1534-1544. doi: 10.3945/ajcn.116.137919. Epub 2016 Oct 26.

Reference Type DERIVED
PMID: 27797709 (View on PubMed)

Other Identifiers

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12/40

Identifier Type: -

Identifier Source: org_study_id

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