The Effect of Whey Protein Supplementation on Vascular and Cognitive Function in Older Adults

October 3, 2017 updated by: Syracuse University

The Effect of Whey Protein Supplementation on Cerebrovascular and Cognitive Function in Older Adults

The "hardening of the arteries" observed with aging raises blood pressure and contributes to poor brain blood flow and loss of cognitive function (i.e. attention, memory, solving problems, making decisions). Cognition is the most important determinant of overall health status, quality of life, functional ability and independence in older adulthood. Nutraceutical strategies have received considerable attention as they may improve cardiovascular health with far fewer side effects compared to drugs. In this regard, dairy products are particularly attractive. Higher dairy consumption is associated with lower blood pressure and improved memory in adults. Milk proteins have natural blood pressure lowering effects. Studies conducted in animals have demonstrated that whey protein (a component of milk protein) may also increase artery elasticity. This is important given the strong association between artery elasticity, brain blood flow, and risk for cognitive decline.

The investigators propose to conduct a randomized double-blind placebo controlled study comparing the effects of whey protein supplementation or carbohydrate placebo on measures of artery elasticity, brain blood flow, and cognitive function in older adults. Whey protein may be a novel dietary therapy to improve both artery health and brain health in older adults.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants will be randomly assigned to receive either 50 g whey protein isolate or placebo each day for 12 weeks.

Study Type

Interventional

Enrollment (Actual)

99

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Syracuse, New York, United States, 13244
        • Syracuse University Human Performance Laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ages of 60-85 years

Exclusion Criteria:

  • acute or terminal illness
  • Montreal Cognitive Assessment < 26 (indicating dementia)
  • myocardial infarction or stroke in the previous 6 months or other symptomatic coronary or peripheral artery disease
  • type I or type II diabetes mellitus
  • visual impairment
  • upper or lower extremity fracture in the previous 6 months
  • uncontrolled hypertension (150/90 mm Hg)
  • cigarette smoking
  • chronic kidney disease (albumin/creatinine ratio (ACR) between 30-300 ug albumin/mg creatinine)
  • liver disease
  • chronic pulmonary/respiratory disease
  • body mass index (kg/m2) < 21 or > 32
  • recent weight loss or gain greater than 7.5% of body weight within the previous 6 months
  • currently supplementing diet with whey protein products
  • milk-protein allergy, or allergy to para-aminobenzoic acid (PABA)
  • head injury or symptoms of concussion in the past 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Whey protein supplement
Subjects will be instructed to consume 40 g whey protein each day for 12 weeks.
Dietary supplement: Whey protein supplement
Supplements will be provided in powder form and mixed into beverages to be consumed twice per day (after breakfast and after dinner).
Other Names:
  • 100% whey protein isolate
Active Comparator: Carbohydrate supplement
Subjects will be instructed to consume a carbohydrate supplement (iso-caloric to the whey supplement) each day for 12 weeks.
Dietary supplement: Carbohydrate supplement
Supplements will be provided in powder form and mixed into beverages to be consumed twice per day (after breakfast and after dinner).
Other Names:
  • Maltodextrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in carotid artery blood pressure at 6 and 12 weeks
Time Frame: These outcomes will be assessed at baseline, 6-weeks and 12-weeks.
These outcomes will be assessed at baseline, 6-weeks and 12-weeks.

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in arterial stiffness at 6 and 12 weeks
Time Frame: These outcomes will be assessed at baseline, 6-weeks and 12-weeks.
These outcomes will be assessed at baseline, 6-weeks and 12-weeks.
Change in endothelial function at 6 and 12 weeks
Time Frame: These outcomes will be assessed at baseline, 6-weeks and 12-weeks.
These outcomes will be assessed at baseline, 6-weeks and 12-weeks.
Change in cognitive function at 6 and 12 weeks
Time Frame: These outcomes will be assessed at baseline, 6-weeks and 12-weeks.
These outcomes will be assessed at baseline, 6-weeks and 12-weeks.
Change in neurovascular coupling (carotid and cognitive perfusion during a mental challenge) at 6 and 12 weeks
Time Frame: These outcomes will be assessed at baseline, 6-weeks and 12-weeks.
These outcomes will be assessed at baseline, 6-weeks and 12-weeks.

Other Outcome Measures

Outcome Measure
Time Frame
Change in physical activity at 6 and 12 weeks
Time Frame: These outcomes will be assessed at baseline, 6-weeks and 12-weeks.
These outcomes will be assessed at baseline, 6-weeks and 12-weeks.
Change in dietary patterns at 6 and 12 weeks
Time Frame: These outcomes will be assessed at baseline, 6-weeks and 12-weeks.
These outcomes will be assessed at baseline, 6-weeks and 12-weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Syracuse University

Collaborators

Dairy Research Institute

Investigators

  • Principal Investigator: Kevin S Heffernan, Ph.D., Syracuse University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2013

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

August 26, 2013

First Submitted That Met QC Criteria

October 7, 2013

First Posted (Estimate)

October 8, 2013

Study Record Updates

Last Update Posted (Actual)

October 4, 2017

Last Update Submitted That Met QC Criteria

October 3, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DRI-1154

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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