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

NCT07167277 | Active Not Recruiting

• 1 other identifier: STUDY00161162
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

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 Protein 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.

Whey Protein

Placebo 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.

Placebo

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older 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.

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Interventions

Whey Proteins

Intervention Hierarchy (Ancestors)

Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Whey; Milk; Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Debra K Sullivan

  Department of Dietetics and Nutrition

  PRINCIPAL INVESTIGATOR

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: December 5, 2025
• Primary Completion: July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)