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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2013 by Syracuse University
Sponsor:
Collaborator:
Dairy Research Institute
Information provided by (Responsible Party):
Syracuse University
ClinicalTrials.gov Identifier:
NCT01956994
First received: August 26, 2013
Last updated: October 7, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Blood Pressure
Dietary Supplement: Whey protein supplement
Dietary Supplement: Carbohydrate supplement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Whey Protein Supplementation on Cerebrovascular and Cognitive Function in Older Adults

Resource links provided by NLM:


Further study details as provided by Syracuse University:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in arterial stiffness at 6 and 12 weeks [ Time Frame: These outcomes will be assessed at baseline, 6-weeks and 12-weeks. ] [ Designated as safety issue: No ]
  • Change in endothelial function at 6 and 12 weeks [ Time Frame: These outcomes will be assessed at baseline, 6-weeks and 12-weeks. ] [ Designated as safety issue: No ]
  • Change in cognitive function at 6 and 12 weeks [ Time Frame: These outcomes will be assessed at baseline, 6-weeks and 12-weeks. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Change in physical activity at 6 and 12 weeks [ Time Frame: These outcomes will be assessed at baseline, 6-weeks and 12-weeks. ] [ Designated as safety issue: No ]
  • Change in dietary patterns at 6 and 12 weeks [ Time Frame: These outcomes will be assessed at baseline, 6-weeks and 12-weeks. ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: October 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Maltodextrin

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   60 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01956994

Contacts
Contact: Kevin S Heffernan, Ph.D. 3154439801 ksheffer@syr.edu
Contact: Nicole L Spartano, Ph.D. 3154152040 nlsparta@syr.edu

Locations
United States, New York
Syracuse University Human Performance Laboratory Not yet recruiting
Syracuse, New York, United States, 13244
Contact: Kevin S Heffernan, Ph.D.    315-443-9801    ksheffer@syr.edu   
Principal Investigator: Kevin S Heffernan, Ph.D.         
Sponsors and Collaborators
Syracuse University
Dairy Research Institute
Investigators
Principal Investigator: Kevin S Heffernan, Ph.D. Syracuse University
  More Information

No publications provided

Responsible Party: Syracuse University
ClinicalTrials.gov Identifier: NCT01956994     History of Changes
Other Study ID Numbers: DRI-1154
Study First Received: August 26, 2013
Last Updated: October 7, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Syracuse University:
Whey Protein
Arterial Stiffness
Neurovascular Coupling
Cerebrovascular Reactivity
Hemodynamics
Blood Flow
Pulsatility

ClinicalTrials.gov processed this record on October 22, 2014