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

NCT01956994 | Completed DMC

• 1 other identifier: DRI-1154
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure

Keywords

Whey Protein; Arterial Stiffness; Neurovascular Coupling; Cerebrovascular Reactivity; Hemodynamics; Blood Flow; Pulsatility

Outcome Measures

Primary Outcomes (1)

• Change in carotid artery blood pressure at 6 and 12 weeks

  These outcomes will be assessed at baseline, 6-weeks and 12-weeks.

Secondary Outcomes (4)

• Change in arterial stiffness at 6 and 12 weeks

  These outcomes will be assessed at baseline, 6-weeks and 12-weeks.

• Change in endothelial function at 6 and 12 weeks

  These outcomes will be assessed at baseline, 6-weeks and 12-weeks.

• Change in cognitive function at 6 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

  These outcomes will be assessed at baseline, 6-weeks and 12-weeks.

Other Outcomes (2)

• Change in physical activity at 6 and 12 weeks

  These outcomes will be assessed at baseline, 6-weeks and 12-weeks.

• Change in dietary patterns at 6 and 12 weeks

  These outcomes will be assessed at baseline, 6-weeks and 12-weeks.

Study Arms (2)

Whey protein supplement

EXPERIMENTAL

Subjects will be instructed to consume 40 g whey protein each day for 12 weeks.

Dietary Supplement: Whey protein supplement

Carbohydrate supplement

ACTIVE COMPARATOR

Subjects will be instructed to consume a carbohydrate supplement (iso-caloric to the whey supplement) each day for 12 weeks.

Dietary Supplement: Carbohydrate supplement

Interventions

Whey protein supplement DIETARY_SUPPLEMENT

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

Also known as: 100% whey protein isolate

Whey protein supplement

Carbohydrate supplement DIETARY_SUPPLEMENT

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

Also known as: Maltodextrin

Carbohydrate supplement

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ages of 60-85 years

You may not qualify if:

• 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)

Sponsors & Collaborators

• Syracuse University: lead
• Dairy Research Institute: collaborator

Study Sites (1)

Syracuse University Human Performance Laboratory

Syracuse, New York, 13244, United States

Location

MeSH Terms

Interventions

maltodextrin

Study Officials

• Kevin S Heffernan, Ph.D.

  Syracuse University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2013
• First Posted: October 8, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 4, 2017

Record last verified: 2017-10

Locations

US (1)