NCT02090842

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Feb 2014

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2013

Completed
8 months until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 18, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

January 11, 2016

Status Verified

January 1, 2016

Enrollment Period

1 year

First QC Date

June 17, 2013

Last Update Submit

January 8, 2016

Conditions

Hypertension

Keywords

Milk proteinsBlood pressureVascular function

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • 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

  • Changes in plasma lipids

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

  • Changes in markers of insulin resistance

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

  • Changes in inflammatory markers

    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)

    Chronic study: Baseline and week 8 assessments for the two dietary intervention arms, Acute study: determined at 0 (fasted), 180, 300, 420 min

  • +1 more secondary outcomes

Other Outcomes (2)

  • Handgrip strength measurement

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

  • Metabonomics

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

Study Arms (3)

Whey protein isolate

EXPERIMENTAL

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

Ca-caseinate

EXPERIMENTAL

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

Dietary Supplement: Ca-caseinate

Maltodextrin

OTHER

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

Dietary Supplement: Maltodextrin

Interventions

Ca-caseinateDIETARY_SUPPLEMENT
Ca-caseinate
MaltodextrinDIETARY_SUPPLEMENT
Maltodextrin
Whey protein isolateDIETARY_SUPPLEMENT
Whey protein isolate

Eligibility Criteria

Age30 Years - 77 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Food and Nutritional Sciences, University of Reading

Reading, Berks, RG6 6AP, United Kingdom

Location

Related Publications (3)

  • 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.

    PMID: 21272399BACKGROUND

  • 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.

    PMID: 19893505BACKGROUND

  • 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.

    PMID: 27797709DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Julie A. Lovegrove, BSc, PhD, RNutr

    University of Reading

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 17, 2013

First Posted

March 18, 2014

Study Start

February 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

January 11, 2016

Record last verified: 2016-01

Locations

GB(1)