The Impact of Whey Protein on Frailty in Older Adults Classified as Pre-frail
NCT ID: NCT07167277
Last Updated: 2025-09-11
Study Results
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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RECRUITING
NA
20 participants
INTERVENTIONAL
2025-10-31
2026-02-28
Brief Summary
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Detailed Description
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Researchers want to see if supplementing with whey protein will improve brain antioxidant status in pre-frail older adults. They will measure this by using special Magnetic Resonance Imaging (MRI) scans.
Participants will be asked to complete a total of 4 study visits, all taking place on the University of Kansas Medical Center (KUMC) main campus. Two of these visits will include an MRI scan. Participation will last about 3 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Whey Protein
Participants will receive the dietary intervention. Participants will take one serving of whey protein per day.
Whey Protein
24g of whey protein will be given to the participant to be consumed daily. Participants will be asked to consume 1 serving per day for 3 months.
Placebo
Participants will receive a placebo. Participants will take one serving of placebo per day.
Placebo
A calorie matched serving of carbohydrate powder will be given to participants to consume daily. Participants will be asked to consume 1 serving per day for 3 months.
Interventions
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Whey Protein
24g of whey protein will be given to the participant to be consumed daily. Participants will be asked to consume 1 serving per day for 3 months.
Placebo
A calorie matched serving of carbohydrate powder will be given to participants to consume daily. Participants will be asked to consume 1 serving per day for 3 months.
Eligibility Criteria
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Inclusion Criteria
* Age 65 to 85
* Speak English as primary language and able to read and write in English
* Stable medication for ≥ 30 days
* Not already taking whey protein over the past 30 days
Exclusion Criteria
* Recent major health concerns
* Insulin-requiring diabetes
* Cancer requiring chemotherapy or radiation within the past 5 years
* Cardiac event (i.e., MI, etc.) in the past year
* Dementia or neurodegenerative disease
* Clinical trial or investigational drug or therapy participation within 30 days of the screening visit or during enrollment in the current study
* MRI contraindications (pacemaker, aneurysm clips, artificial heart valves, metal fragments, foreign objects or claustrophobia)
* Dairy Allergy or excluding dairy from diet for other reasons
* Weight \> 350 lbs.
* The presence of major psychiatric disorders within the past 3 years including depression, anxiety, and alcohol (over 3 drinks/day or a total of 18 drinks/week) or drug abuse.
65 Years
85 Years
ALL
No
Sponsors
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University of Kansas Medical Center
OTHER
Responsible Party
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Principal Investigators
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Debra K Sullivan
Role: PRINCIPAL_INVESTIGATOR
Department of Dietetics and Nutrition
Locations
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The University of Kansas Medical Center
Kansas City, Kansas, United States
Countries
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Central Contacts
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Other Identifiers
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STUDY00161162
Identifier Type: -
Identifier Source: org_study_id
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