Whey protein to boost brain antioxidants and physical function in pre-frail older adults
Impact of Whey Protein on Frailty - a Pilot Study
This study will try giving whey protein or a placebo to people aged 65–85 who are pre-frail to see if it raises brain antioxidant levels and improves strength, body composition, and thinking.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 65 Years to 85 Years |
| Sex | All |
| Sponsor | University of Kansas Medical Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Kansas City, Kansas) |
| Trial ID | NCT07167277 on ClinicalTrials.gov |
What this trial studies
Researchers will enroll pre-frail adults aged 65–85 and assign them to take either whey protein or a placebo for about three months while remaining on stable medications. Participants will complete four visits at the University of Kansas Medical Center, including two visits with special MRI scans that measure brain glutathione (GSH) levels. The study will also measure physical function, body composition, dietary intake, and cognition before and after the supplementation period. Outcomes will compare changes in brain antioxidant status and functional measures between the whey and placebo groups.
Who should consider this trial
Good fit: Ideal candidates are English-speaking adults aged 65–85 who meet Fried's pre-frail criteria, are medically stable, not currently taking whey protein, and can undergo MRI scans at KUMC.
Not a fit: Patients with advanced frailty or excluded conditions—such as kidney disease, insulin-requiring diabetes, dementia, recent cancer therapy, dairy allergy, or those unable to attend on-site MRI visits—are unlikely to benefit or are ineligible.
Why it matters
Potential benefit: If successful, whey protein supplementation could increase brain antioxidant levels and lead to improvements in muscle strength, body composition, and cognitive function in pre-frail older adults.
How similar studies have performed: Prior studies of protein supplementation in older adults have shown benefits for muscle mass and function, but evidence that whey increases brain glutathione is limited and less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Kansas City, Kansas
- The University of Kansas Medical Center — Kansas City, Kansas, United States (Recruiting)
Study contacts
- Principal investigator: Debra K Sullivan — Department of Dietetics and Nutrition
- Study coordinator: Caitlin Payne
- Email: sullivannutritionres@kumc.edu
- Phone: 913-588-6254
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.