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

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01956994
• Other study ID #: DRI-1154
• Status: Completed
• Phase: N/A
• First received: August 26, 2013
• Last updated: October 3, 2017
• Start date: October 2013
• Est. completion date: December 2016

Study information

• Verified date: October 2017
• Source: Syracuse University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure

Intervention

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).
• Carbohydrate supplement
Supplements will be provided in powder form and mixed into beverages to be consumed twice per day (after breakfast and after dinner).

Locations

Country	Name	City	State
United States	Syracuse University Human Performance Laboratory	Syracuse	New York

Sponsors (2)

Lead Sponsor	Collaborator
Syracuse University	Dairy Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in physical activity at 6 and 12 weeks		These outcomes will be assessed at baseline, 6-weeks and 12-weeks.
Other	Change in dietary patterns at 6 and 12 weeks		These outcomes will be assessed at baseline, 6-weeks and 12-weeks.
Primary	Change in carotid artery blood pressure at 6 and 12 weeks		These outcomes will be assessed at baseline, 6-weeks and 12-weeks.
Secondary	Change in arterial stiffness at 6 and 12 weeks		These outcomes will be assessed at baseline, 6-weeks and 12-weeks.
Secondary	Change in endothelial function at 6 and 12 weeks		These outcomes will be assessed at baseline, 6-weeks and 12-weeks.
Secondary	Change in cognitive function at 6 and 12 weeks		These outcomes will be assessed at baseline, 6-weeks and 12-weeks.
Secondary	Change in neurovascular coupling (carotid and cognitive perfusion during a mental challenge) at 6 and 12 weeks		These outcomes will be assessed at baseline, 6-weeks and 12-weeks.