Pre-frailNCT07167277
The Impact of Whey Protein on Frailty in Older Adults Classified as Pre-frail
A study testing Whey Protein in people with Pre-frail and Pre-Frail Older Adults, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Pre-frail, Pre-Frail Older Adults, Cognition
- What is being tested?
- Whey Protein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2025to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: 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.
Read the 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.
- Conditions
- Pre-frail, Pre-Frail Older Adults, Cognition, Physical Function, Dietary Intake Assessment, MRI
- Being tested
- Whey Protein, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey ProteinDietary 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.
PlaceboDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Whey Protein | Experimental | Participants will receive the dietary intervention. Participants will take one serving of whey protein per day. Receives: Dietary Supplement: Whey Protein |
| Placebo | Active comparator | Participants will receive a placebo. Participants will take one serving of placebo per day. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in brain glutathione (GSH) levels measured using MRI scans.
Brain GSH levels will be measured using 3T MRI scans.
Measured: Changes from baseline to 3 months.
Secondary outcomes (3)
Assess the change in physical function by measuring balance resistance, sit-to-stand, muscle strength and performance.
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.
Measured: Changes from baseline to 3 months.
Assess body composition with a bioelectrical impedance analysis (BIA) device.
To measure, subjects will stand on the device, covering the electrodes with their hands and feet. The measure takes less than 2 minutes.
Measured: Changes from baseline to 3 months.
Assess cognition using the NIH Toolbox cognition battery.
The NIH Toolbox cognition battery will include 5 tests resulting in a composite score. The exam will be administered on an iPad device.
Measured: Changes from baseline to 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start5 Dec 2025
- Primary completionJul 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-frailStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Debra K Sullivan, Principal investigator, Department of Dietetics and Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07167277
- Sponsor's protocol ID
- STUDY00161162
- Status last verified
- May 2026
- First submitted
- 11 Aug 2025
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Whey Protein on Frailty - a Pilot Study
- ClinicalTrials.gov ID
- NCT07167277
- Acronym / sponsor ID
- STUDY00161162
- Conditions
- Pre-frail, Pre-Frail Older Adults, Cognition, Physical Function, Dietary Intake Assessment, MRI
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 5 Dec 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 11 Sep 2025 (actual)
- 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.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whey Protein | Experimental | Dietary Supplement: Whey ProteinParticipants will receive the dietary intervention. Participants will take one serving of whey protein per day. |
| Placebo | Active comparator | Dietary Supplement: PlaceboParticipants will receive a placebo. Participants will take one serving of placebo per day. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
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 Protein24g 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. | Dietary supplement | Whey Protein |
| PlaceboA 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. | Dietary supplement | Placebo |
Primary outcome
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.
3 secondary outcomes
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.
Assess body composition with a bioelectrical impedance analysis (BIA) device.
Time frame: Changes from baseline to 3 months.
Assess cognition using the NIH Toolbox cognition battery.
Time frame: Changes from baseline to 3 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: No
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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.
Debra K Sullivan principal investigator
Department of Dietetics and Nutrition
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 in people with Pre-frail and Pre-Frail Older Adults, run by University of Kansas Medical Center 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 5 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 14 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
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 brain glutathione (GSH) levels measured using MRI scans. (time frame: Changes from baseline to 3 months.). 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 14 May 2026.