Dietary Protein for Muscle Wasting

Overseen By Emily E Howard, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: United States Army Research Institute of Environmental Medicine

Must not be taking: Statins, Corticosteroids, Ozempic, others

Disqualifiers: Thrombosis, Diabetes, Cardiovascular disease, others

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

Compensation: Varies

Number of Visits: 2

28 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the optimal dose of whey protein to prevent muscle loss after a leg injury when muscles are less active. It compares the effects of consuming 20 grams versus 40 grams of whey protein on muscle recovery during a period of leg rest. The trial seeks participants aged 18-39 who exercise at least twice a week and are willing to avoid alcohol and certain supplements during the study. As an unphased trial, it offers participants the chance to contribute to research that could improve muscle recovery strategies for active individuals.

Will I have to stop taking my current medications?

The trial requires that participants not take medications that affect how the body uses nutrients, like statins or corticosteroids. If you're on such medications, you may need to stop them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that whey protein is generally safe for consumption. It can improve muscle strength and increase muscle mass, particularly when muscles weaken due to inactivity. Whey protein contains essential amino acids, crucial for muscle repair and growth.

However, results on whey protein's ability to prevent muscle loss are mixed. Some studies found that while it may help maintain muscle, it doesn't always significantly boost overall muscle strength or physical performance.

Most people tolerate whey protein well, but some might experience mild side effects like stomach issues. Prospective trial participants should consider their dietary needs and consult a healthcare provider if they have concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for muscle wasting, which often involve physical therapy and resistance exercises, this approach uses whey protein supplements to potentially address muscle loss. Researchers are excited about this treatment because whey protein is a readily available and easily digestible source of high-quality protein that can be quickly incorporated into a diet. The trial explores both a standard (20g) and a high (40g) protein dose, aiming to determine if increased protein intake can more effectively prevent muscle loss after short periods of inactivity. This could offer a simple and non-invasive alternative to traditional therapies, particularly for individuals unable to engage in regular exercise.

What evidence suggests that this trial's treatments could be effective for muscle wasting?

This trial will compare the effects of different doses of whey protein on muscle wasting. Studies have shown mixed results for using whey protein to prevent muscle loss during inactivity. Some research suggests moderate amounts of whey protein can help maintain muscle mass, but other studies found no clear benefit. For instance, taking about 20 grams of protein twice a day did not prevent muscle loss in older men during short periods of inactivity. However, whey protein has been shown to help build muscle and strength when combined with exercise. Its effectiveness may depend on the amount taken, timing, and individual differences. Therefore, the effectiveness of whey protein alone in preventing muscle loss from inactivity remains unclear. Participants in this trial will receive either a standard protein dose of 20 g or a high protein dose of 40 g after 5 days of muscle disuse to evaluate its effectiveness. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals who have experienced muscle loss due to injuries and are facing reduced muscle activity. It aims to understand if higher protein intake can help preserve muscle mass during recovery.

Inclusion Criteria

Body mass index (BMI) between 18.5-32 kg/m2

Routinely participate in aerobic and/or resistance exercise at least 2 days per week

Willing to refrain from alcohol, smoking, smokeless nicotine products (includes e-cigarettes, vaping, chewing tobacco), and dietary supplements (i.e., vitamin D, probiotics) 24 hours before and during immobilization and final testing day

Exclusion Criteria

Significantly abnormal blood clotting as determined by USARIEM Office of Medical Oversight (OMSO) or home duty station medical support (HMS)

Allergy to lidocaine (or similar local anesthetic)

Present condition of alcoholism, anabolic steroid use, or other substance abuse issues as determined by OMSO or HMS

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Immobilization

Participants undergo muscle disuse through unilateral leg immobilization for five days

5 days

1 visit (in-person) for immobilization setup

Protein Feeding Study

Participants complete a protein feeding study with primed, continuous stable isotope infusions, serial blood draws, and muscle biopsies

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the intervention

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Whey Protein

Trial Overview The study is testing the effects of two different amounts of dietary protein, 20 grams versus 40 grams, on muscle synthesis when one leg is immobilized. The goal is to find the optimal protein dose for maintaining muscle during inactivity.

How Is the Trial Designed?

Group I: Standard Protein Dose Active Control 1 Intervention

Participants will consume 20 g of whey protein after 5 days of muscle disuse

Group II: High Protein Dose Active Control 1 Intervention

Participants will consume 40 g of whey protein after 5 days of muscle disuse

Who Is Running the Clinical Trial?

United States Army Research Institute of Environmental Medicine

Lead Sponsor

Trials

67

Recruited

3,700+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8075117/

Practical applications of whey protein in supporting skeletal ... Emerging research from human studies suggests that moderate amounts of high-quality protein may attenuate the loss of muscle, while preventing accumulation of ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0022316622009555

Skeletal Muscle Disuse Atrophy Is Not Attenuated by ... In conclusion, dietary protein supplementation (∼20 g twice daily) does not attenuate muscle loss during short-term muscle disuse in healthy older men. This ...

3. physoc.onlinelibrary.wiley.com physoc.onlinelibrary.wiley.com/doi/full/10.1113/EP090434

The effect of protein or amino acid provision on immobilization ... Protein or amino acid provision before or during a period of disuse does not prevent the reductions in skeletal muscle mass, strength or muscle ...

4. mdpi.com mdpi.com/2072-6643/15/4/1003

Effects of Whey Protein Supplement on 4-Week Resistance ... The results of this study indicate that whey protein supplementation promotes muscle mass increase and selective increases in muscular strength and endurance ...

5. bmcgeriatr.biomedcentral.com bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-025-05885-x

Effects of protein supplementation on muscle mass, muscle ... The influence of protein on muscle mass was not significantly efficacious, and mixed results were shown for muscle strength and physical performance.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7284346/

Nutritional Strategies to Offset Disuse-Induced Skeletal ... The current review therefore aims to provide an overview of nutritional countermeasures to disuse atrophy and anabolic resistance in older individuals.

7. mdpi.com mdpi.com/2072-6643/12/11/3362

Soluble Whey Protein Hydrolysate Ameliorates Muscle ... Soluble whey protein hydrolysate (WP-S) had the greatest increase in grip strength, muscle weight, and cross-sectional area of muscle fiber than other whey ...

8. academic.oup.com academic.oup.com/jcem/article/98/12/4872/2834718

Disuse Impairs the Muscle Protein Synthetic Response to ... The principal finding from the present study was that 2 weeks of one-legged knee immobilization impaired the muscle protein synthetic response to the ingestion ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S0002916522030246

A randomized controlled trial of the impact of protein ... An increase in dietary protein intake may alleviate inactivity‐induced muscle loss (9, 10). Whey protein has a high essential amino acid (EAA) content, ...