Clinical trial NCT01956994: The Effect of Whey Protein Supplementation on Vascular and Cognitive Function in Older Adults
Official title: The Effect of Whey Protein Supplementation on Cerebrovascular and Cognitive Function in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Keywords: Whey Protein
Arterial Stiffness
Neurovascular Coupling
Cerebrovascular Reactivity
Hemodynamics
Blood Flow
Pulsatility
Lead sponsor: Syracuse University
Sponsor class: OTHER
Collaborators: name: Dairy Research Institute
First posted: 2013-10-08
Enrollment: 99
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Eligibility 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

Primary outcomes:
measure: Change in carotid artery blood pressure at 6 and 12 weeks
timeFrame: These outcomes will be assessed at baseline, 6-weeks and 12-weeks.
Secondary outcomes:
measure: Change in arterial stiffness at 6 and 12 weeks
timeFrame: These outcomes will be assessed at baseline, 6-weeks and 12-weeks.
measure: Change in endothelial function at 6 and 12 weeks
timeFrame: These outcomes will be assessed at baseline, 6-weeks and 12-weeks.
measure: Change in cognitive function at 6 and 12 weeks
timeFrame: These outcomes will be assessed at baseline, 6-weeks and 12-weeks.
measure: Change in neurovascular coupling (carotid and cognitive perfusion during a mental challenge) at 6 and 12 weeks
timeFrame: These outcomes will be assessed at baseline, 6-weeks and 12-weeks.
Other outcomes:
measure: Change in physical activity at 6 and 12 weeks
timeFrame: These outcomes will be assessed at baseline, 6-weeks and 12-weeks.
measure: Change in dietary patterns at 6 and 12 weeks
timeFrame: These outcomes will be assessed at baseline, 6-weeks and 12-weeks.
Locations:
city: Syracuse
country: United States
facility: Syracuse University Human Performance Laboratory
state: New York
Study officials:
affiliation: Syracuse University
name: Kevin S Heffernan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: