The Impact of Whey Protein on Frailty in Older Adults Classified as Pre-frail

NCT ID: NCT07167277

Last Updated: 2025-09-11

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

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-31

Study Completion Date

2026-02-28

Brief Summary

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This pilot study aims to determine the impact of whey protein supplementation on brain antioxidant levels and to assess the effects of whey protein supplementation on physical function, body composition, and cognition in pre-frail older adults.

Detailed Description

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Frailty is characterized by weakness, muscle loss, and physical impairment. It is suggested that long term oxidative stress might contribute to frailty. Glutathione (GSH), an antioxidant in cells, is needed to combat oxidative stress. Whey protein has the potential to increase brain antioxidant (GSH) levels by aiding in antioxidant synthesis. Frail older adults under-consume protein compared to healthy older adults.

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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Pre-frail Pre-Frail Older Adults Cognition Physical Function Dietary Intake Assessment MRI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Whey Protein

Participants will receive the dietary intervention. Participants will take one serving of whey protein per day.

Group Type EXPERIMENTAL

Whey Protein

Intervention Type DIETARY_SUPPLEMENT

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.

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Pre-frail according to Fried's phenotype
* 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

* Acute or chronic kidney disease
* 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.
Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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United States

Central Contacts

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Caitlin Payne

Role: CONTACT

913-588-6254

Other Identifiers

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STUDY00161162

Identifier Type: -

Identifier Source: org_study_id

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