Blood PressureNCT01956994
The Effect of Whey Protein Supplementation on Vascular and Cognitive Function in Older Adults
A study testing Whey protein supplement and Carbohydrate supplement in people with Blood Pressure, run by Syracuse University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Whey protein supplement and Carbohydrate supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ages of 60-85 years
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Syracuse University Human Performance Laboratory
Syracuse, New York, 13244
About this study
Official title: The Effect of Whey Protein Supplementation on Cerebrovascular 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.
Read the detailed description
Participants will be randomly assigned to receive either 50 g whey protein isolate or placebo each day for 12 weeks.
- Conditions
- Blood Pressure
- Being tested
- Whey protein supplement, Carbohydrate supplement
- Keywords
- Whey Protein, Arterial Stiffness, Neurovascular Coupling, Cerebrovascular Reactivity, Hemodynamics, Blood Flow, Pulsatility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey protein supplementDietary supplement
Also called 100% whey protein isolate
Supplements will be provided in powder form and mixed into beverages to be consumed twice per day (after breakfast and after dinner).
Carbohydrate supplementDietary supplement
Also called Maltodextrin
Supplements will be provided in powder form and mixed into beverages to be consumed twice per day (after breakfast and after dinner).
| Study group | Role | What they receive |
|---|---|---|
| Whey protein supplement | Experimental | Subjects will be instructed to consume 40 g whey protein each day for 12 weeks. Receives: 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. Receives: Dietary Supplement: Carbohydrate supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in carotid artery blood pressure at 6 and 12 weeks
Measured: These outcomes will be assessed at baseline, 6-weeks and 12-weeks.
Secondary outcomes (4)
Change in arterial stiffness at 6 and 12 weeks
Measured: These outcomes will be assessed at baseline, 6-weeks and 12-weeks.
Change in endothelial function at 6 and 12 weeks
Measured: These outcomes will be assessed at baseline, 6-weeks and 12-weeks.
Change in cognitive function at 6 and 12 weeks
Measured: 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
Measured: These outcomes will be assessed at baseline, 6-weeks and 12-weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syracuse University
- Sponsor type
- University, hospital or other
- Collaborators
- Dairy Research Institute
- Responsible party
- Sponsor
- Investigators
- Kevin S Heffernan, Ph.D., Principal investigator, Syracuse University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01956994
- Sponsor's protocol ID
- DRI-1154
- Status last verified
- Oct 2017
- First submitted
- 26 Aug 2013
- Last updated
- 4 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Whey Protein Supplementation on Cerebrovascular and Cognitive Function in Older Adults
- ClinicalTrials.gov ID
- NCT01956994
- Acronym / sponsor ID
- DRI-1154
- Conditions
- Blood Pressure
- Keywords
- Whey Protein, Arterial Stiffness, Neurovascular Coupling, Cerebrovascular Reactivity, Hemodynamics, Blood Flow, Pulsatility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Syracuse UniversityUniversity, hospital or other
- Collaborators
- Dairy Research Institute
- Study start
- Oct 2013 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 8 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whey protein supplement | Experimental | Dietary Supplement: Whey protein supplementSubjects will be instructed to consume 40 g whey protein each day for 12 weeks. |
| Carbohydrate supplement | Active comparator | Dietary Supplement: Carbohydrate supplementSubjects will be instructed to consume a carbohydrate supplement (iso-caloric to the whey supplement) each day for 12 weeks. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ages of 60-85 years
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whey protein supplementAlso: 100% whey protein isolateSupplements will be provided in powder form and mixed into beverages to be consumed twice per day (after breakfast and after dinner). | Dietary supplement | Whey protein supplement |
| Carbohydrate supplementAlso: MaltodextrinSupplements will be provided in powder form and mixed into beverages to be consumed twice per day (after breakfast and after dinner). | Dietary supplement | Carbohydrate supplement |
Primary outcome
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.
4 secondary outcomes
Change in arterial stiffness at 6 and 12 weeks
Time frame: These outcomes will be assessed at baseline, 6-weeks and 12-weeks.
Change in endothelial function at 6 and 12 weeks
Time frame: These outcomes will be assessed at baseline, 6-weeks and 12-weeks.
Change in cognitive function at 6 and 12 weeks
Time frame: 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
Time frame: These outcomes will be assessed at baseline, 6-weeks and 12-weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin S Heffernan, Ph.D. principal investigator
Syracuse University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey protein supplement and Carbohydrate supplement in people with Blood Pressure, run by Syracuse University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2017.