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

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ClinicalTrials.gov Identifier: NCT01956994
Recruitment Status : Completed
First Posted : October 8, 2013
Last Update Posted : October 4, 2017
Sponsor:
Collaborator:
Dairy Research Institute
Information provided by (Responsible Party):
Syracuse University

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Blood Pressure Dietary Supplement: Whey protein supplement Dietary Supplement: Carbohydrate supplement Not Applicable

Detailed Description:
Participants will be randomly assigned to receive either 50 g whey protein isolate or placebo each day for 12 weeks.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Whey Protein Supplementation on Cerebrovascular and Cognitive Function in Older Adults
Actual Study Start Date : October 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 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


Outcome Measures
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Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. Change in arterial stiffness at 6 and 12 weeks [ Time Frame: These outcomes will be assessed at baseline, 6-weeks and 12-weeks. ]
  2. Change in endothelial function at 6 and 12 weeks [ Time Frame: These outcomes will be assessed at baseline, 6-weeks and 12-weeks. ]
  3. Change in cognitive function at 6 and 12 weeks [ Time Frame: These outcomes will be assessed at baseline, 6-weeks and 12-weeks. ]
  4. 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. ]

Other Outcome Measures:
  1. Change in physical activity at 6 and 12 weeks [ Time Frame: These outcomes will be assessed at baseline, 6-weeks and 12-weeks. ]
  2. Change in dietary patterns at 6 and 12 weeks [ Time Frame: These outcomes will be assessed at baseline, 6-weeks and 12-weeks. ]

Eligibility Criteria
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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01956994


Locations
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United States, New York
Syracuse University Human Performance Laboratory
Syracuse, New York, United States, 13244
Sponsors and Collaborators
Syracuse University
Dairy Research Institute
Investigators
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Principal Investigator: Kevin S Heffernan, Ph.D. Syracuse University
More Information
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Responsible Party: Syracuse University
ClinicalTrials.gov Identifier: NCT01956994    
Other Study ID Numbers: DRI-1154
First Posted: October 8, 2013    Key Record Dates
Last Update Posted: October 4, 2017
Last Verified: October 2017
Keywords provided by Syracuse University:
Whey Protein
Arterial Stiffness
Neurovascular Coupling
Cerebrovascular Reactivity
 Hemodynamics
Blood Flow
Pulsatility