Whey Protein for Pre-frailty

Overseen By Caitlin Payne

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Disqualifiers: Kidney disease, Diabetes, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether whey protein can improve brain health, physical ability, body composition, and thinking skills in older adults who are beginning to show signs of frailty (pre-frail). Participants will take either a daily serving of whey protein or a placebo (inactive substance) to compare results. Eligible participants should be between 65-85 years old, show some signs of frailty, and not currently use whey protein.

As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance the quality of life for older adults.

Do I need to stop taking my current medications for the trial?

The trial requires that your current medications have been stable for at least 30 days, but it doesn't specify that you need to stop taking them. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that whey protein supplementation is safe for pre-frail older adults?

Studies have shown that whey protein is generally safe and well-tolerated by older adults. Research indicates that consuming more animal protein, such as whey protein, can help lower the risk of frailty without causing major side effects. One study suggested that adequate protein intake can prevent muscle loss and frailty, also without noticeable side effects. Overall, whey protein appears to be a safe choice for improving health in older adults, particularly in addressing frailty. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about whey protein for pre-frailty because it offers a simple, nutritional approach that differs from typical interventions like exercise or medication. Whey protein is rich in essential amino acids, which are crucial for muscle repair and growth, and it may help improve muscle strength and function in older adults at risk of frailty. Unlike some treatments that require complex regimens or have side effects, whey protein is easy to incorporate into a daily diet, making it an accessible option for enhancing physical health in a vulnerable population.

What evidence suggests that whey protein might be an effective treatment for pre-frailty?

Research has shown that whey protein might help older adults enhance their physical abilities and muscle mass. In this trial, participants in one arm will receive whey protein as a dietary intervention. Studies have found that whey protein can increase brain antioxidants, potentially protecting against aging. It has also boosted muscle strength and movement, which are crucial for maintaining independence in older age. Additionally, whey protein intake has been linked to improved frailty status and mental performance. These benefits suggest whey protein could be beneficial for older adults who are starting to feel weaker and wish to improve their overall health and abilities. ^{1 3 6 7 8}

Who Is on the Research Team?

Debra K Sullivan

Principal Investigator

Department of Dietetics and Nutrition

Are You a Good Fit for This Trial?

This trial is for older adults aged 65 to 85 who are pre-frail but generally healthy. They must be on stable medication, not have taken whey protein recently, and able to communicate in English. Exclusions include those with recent major health issues, dairy allergies, certain mental health conditions, heavy alcohol or drug use, kidney disease, insulin-requiring diabetes, recent cancer treatments or cardiac events.

Inclusion Criteria

I am between 65 and 85 years old.

Stable medication for ≥ 30 days

Not already taking whey protein over the past 30 days

Exclusion Criteria

Recent major health concerns

Dementia or neurodegenerative disease

Dairy Allergy or excluding dairy from diet for other reasons

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive whey protein or placebo supplementation daily, with assessments including MRI scans and physical function tests

12 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Whey Protein

Trial Overview The study tests if whey protein can improve brain antioxidant levels and benefit physical function, body composition and cognition in pre-frail older adults. Participants will receive either whey protein or a placebo without knowing which one they're getting.

How Is the Trial Designed?

Group I: Whey Protein Experimental Treatment 1 Intervention

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

Group II: Placebo Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07167277

The Impact of Whey Protein on Frailty in Older Adults ... Whey protein has the potential to increase brain antioxidant (GSH) levels by aiding in antioxidant synthesis. Frail older adults under-consume ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6315527/

Effects of Protein Supplementation Combined with ... Our findings suggest that PS plus RET as well as MET is effective in improving frailty status, lean mass, muscle strength, and physical mobility in frail older ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0002916522030313

Protein supplementation improves muscle mass and ... The present study indicates that protein intake of 1.5 g · kg –1 · d –1 has the most beneficial effects in regard to preventing sarcopenia and frailty.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10421506/

Effectiveness of Whey Protein Supplementation during ... Conclusions: WP supplementation during RET is more effective in increasing handgrip strength and skeletal muscle mass in older people with ...

5. tandfonline.com tandfonline.com/doi/abs/10.1080/21551197.2021.1886222

A Randomized Controlled Pilot Exercise and Protein ... Secondary outcomes included: frailty score, muscle mass, quality of life, nutritional intake, cognitive performance, depression and physical ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7598653/

Protein Intake and Frailty: A Matter of Quantity, Quality, and ... Results from the Seniors-ENRICA study [76] are in line with this perspective by demonstrating that higher animal protein intake reduced the risk of frailty in ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11614966/

Interventions to prevent the onset of frailty in adults aged ... A systematic review of RCTs observed a non-significant increase in gait speed after protein supplementation alone (mean duration 31 weeks) in ...

8. mdpi.com mdpi.com/2072-6643/11/1/102

Dietary Factors Associated with Frailty in Old Adults The few studies performed to date seem to indicate that there is a protective role of protein supplementation against frailty syndrome. In this ...