NCT07167277

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 11, 2025

Completed
20 days until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

September 11, 2025

Status Verified

September 1, 2025

Enrollment Period

4 months

First QC Date

August 11, 2025

Last Update Submit

September 8, 2025

Conditions

Pre-frailPre-Frail Older AdultsCognitionPhysical FunctionDietary Intake AssessmentMRI

Outcome Measures

Primary Outcomes (1)

  • Change in brain glutathione (GSH) levels measured using MRI scans.

    Brain GSH levels will be measured using 3T MRI scans.

    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.

    Changes from baseline to 3 months.

  • Assess body composition with a bioelectrical impedance analysis (BIA) device.

    Changes from baseline to 3 months.

  • Assess cognition using the NIH Toolbox cognition battery.

    Changes from baseline to 3 months.

Study Arms (2)

Whey Protein

EXPERIMENTAL

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

Dietary Supplement: Whey Protein

Placebo

ACTIVE COMPARATOR

Participants will receive a placebo. Participants will take one serving of placebo per day.

Dietary Supplement: Placebo

Interventions

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.

Whey Protein
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.

Placebo

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

MeSH Terms

Interventions

Whey Proteins

Intervention Hierarchy (Ancestors)

Milk ProteinsAnimal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsWheyMilkDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Debra K Sullivan

    Department of Dietetics and Nutrition

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Caitlin Payne

CONTACT

913-588-6254sullivannutritionres@kumc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2025

First Posted

September 11, 2025

Study Start

October 1, 2025

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

September 11, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)