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Clinical Trials/NCT02090842
NCT02090842CompletedNot Applicable

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

University of Reading2 sites in 1 country38 target enrollmentStarted: February 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
38
Locations
2
Primary Endpoint
Change in 24-h ambulatory blood pressure

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Prevention
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
30 Years to 77 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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)
  • Taking nutritional supplementation (e.g. fish oil, proteins)

Outcomes

Primary Outcomes

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

  • 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 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)
  • 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)
  • Changes in markers of insulin resistance(Chronic study: Baseline and week 8 assessments for the two dietary intervention arms, Acute study: fasted and postprandial)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Julie Lovegrove

Professor

University of Reading

Study Sites (2)

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