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

NCT ID: NCT01956994

Last Updated: 2017-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2016-12-31

Brief Summary

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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

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

Conditions

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Blood Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Whey protein supplement

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

Group Type EXPERIMENTAL

Whey protein supplement

Intervention Type DIETARY_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

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

Group Type ACTIVE_COMPARATOR

Carbohydrate supplement

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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).

Intervention Type 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).

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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100% whey protein isolate Maltodextrin

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dairy Research Institute

OTHER

Sponsor Role collaborator

Syracuse University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kevin S Heffernan, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Syracuse University

Locations

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Syracuse University Human Performance Laboratory

Syracuse, New York, United States

Site Status

Countries

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United States

Other Identifiers

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DRI-1154

Identifier Type: -

Identifier Source: org_study_id