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

May 12, 2026 updated by: University of Kansas Medical Center

Impact of Whey Protein on Frailty - a Pilot Study

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • The University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Whey Protein
Participants will receive the dietary intervention. Participants will take one serving of whey protein per day.
Dietary supplement: 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.
Active Comparator: Placebo
Participants will receive a placebo. Participants will take one serving of placebo per day.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in brain glutathione (GSH) levels measured using MRI scans.
Time Frame: Changes from baseline to 3 months.
Brain GSH levels will be measured using 3T MRI scans.
Changes from baseline to 3 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the change in physical function by measuring balance resistance, sit-to-stand, muscle strength and performance.
Time Frame: Changes from baseline to 3 months.
Balance resistance will be measured with a pressure-sensitive walkway. Sit-to-stand will be measured by number of repetitions in 30 seconds and the time to complete 5 repetitions. Muscle strength and performance will be measured by grip strength and gait speed. Grip strength is measured 3 times and averaged. Gait speed is measured with a 15-foot walk test and will be measured twice.
Changes from baseline to 3 months.
Assess body composition with a bioelectrical impedance analysis (BIA) device.
Time Frame: Changes from baseline to 3 months.
To measure, subjects will stand on the device, covering the electrodes with their hands and feet. The measure takes less than 2 minutes.
Changes from baseline to 3 months.
Assess cognition using the NIH Toolbox cognition battery.
Time Frame: Changes from baseline to 3 months.
The NIH Toolbox cognition battery will include 5 tests resulting in a composite score. The exam will be administered on an iPad device.
Changes from baseline to 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Investigators

  • Principal Investigator: Debra K Sullivan, Department of Dietetics and Nutrition

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

August 11, 2025

First Submitted That Met QC Criteria

September 8, 2025

First Posted (Actual)

September 11, 2025

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00161162

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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