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OpenTrials
Completed

NCT Number: NCT01956994

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

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.

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Key information

Conditions

Blood Pressure

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Syracuse University Human Performance Laboratory

Syracuse, New York, 13244, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Other names: 100% whey protein isolate

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).

Other names: Maltodextrin

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Syracuse University

Other

Collaborators

  • Dairy Research Institute

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Oct 8, 2013
Registry last updated
Oct 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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