Amino Acids for Sarcopenia

(BOOST_CKD Trial)

SD
Overseen BySubrata Debnath, PhD
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: The University of Texas Health Science Center at San Antonio
Must be taking: SGLT2-i, GLP-1 agonist
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether specific amino acids can help individuals with advanced kidney disease improve muscle mass and strength. It targets those who struggle to build muscle due to a necessary low-protein diet for kidney health. The study will test valine and a mix of essential amino acids (EEA) to determine which is more effective. This trial may suit individuals with advanced kidney disease who are not on dialysis, experience muscle weakness, and can adhere to a set diet and lifestyle. As an Early Phase 1 trial, the research aims to understand how these amino acids function in people, offering participants the opportunity to explore new treatment possibilities.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on an SGLT2-i or GLP-1 agonist, you should be on a stable dose for at least 3 months before joining the study, with no dose changes expected in the next 4 months.

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

Research has shown that valine, a type of amino acid, offers health benefits in several studies. In animal studies, valine extended lifespan. However, limited information exists about its safety for humans with sarcopenia, which involves muscle loss.

Studies on essential amino acids (EAAs) suggest they can improve muscle strength and mass, offering hope for those with sarcopenia. EAAs have been used in various contexts with positive results and no major safety issues reported so far.

This trial is in an early stage, so researchers are still collecting safety information. However, the use of amino acids like valine and EAAs in other areas suggests they are generally safe. Participants should consult their doctors about any concerns before joining the trial.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for sarcopenia because they harness the power of amino acids, which are the building blocks of protein, essential for muscle health. Unlike standard treatments that might focus on exercise or hormone therapy, the investigational treatments use Valine and essential amino acids (EAA) to directly support muscle growth and repair. Valine offers a targeted approach with a smaller, easily managed dosage (2 g daily), while the EAA treatment provides a broader spectrum of amino acids, including branched-chain amino acids (BCAAs), delivering a robust 20 g daily. This dual approach could offer a promising new pathway to combat muscle loss more effectively and efficiently.

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

Research has shown that higher levels of valine, a type of amino acid, link to a 47% lower risk of developing sarcopenia, which involves the loss of muscle mass and strength. Valine also aids in energy production and may protect muscles from damage. In this trial, one group of participants will receive valine. Additionally, essential amino acids (EEA) have shown promise in boosting muscle strength and lean body mass in older adults. Studies have found that consuming more EEA links to stronger muscles and better muscle health. Another group in this trial will receive EEA. Overall, both valine and EEA may support muscle health and reduce the effects of sarcopenia.23456

Who Is on the Research Team?

SD

Subrata Debnath, PhD

Principal Investigator

The University of Texas Health Science Center at San Antonio

Are You a Good Fit for This Trial?

This trial is for men and women aged 45-75 with advanced chronic kidney disease (very low kidney function but not on dialysis) who have muscle weakness, are following standard care for their conditions, and meet certain lab criteria. Participants must be able to give consent and not expect to start dialysis soon.

Inclusion Criteria

I am not on dialysis and do not expect to need it in the next 4 months.
I understand the study and am willing to sign a consent form.
My hand grip strength is below 26 kg (male) or 16 kg (female).
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily oral consumption of either 2 g valine or 20 g essential amino acids (EAA) for 6 weeks

6 weeks
Regular monitoring visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • EEA
  • Valine

Trial Overview

The study tests whether two different amino acids—Valine or Essential Amino Acids (EEA)—can help improve muscle mass and strength in people with severe kidney disease. Participants will receive one of these supplements while continuing their usual care.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Treatment group ValineExperimental Treatment1 Intervention
Group II: Treatment group EEAExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials
486
Recruited
92,500+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Citations

Potential Application of Essential Amino Acid ... - PMC

In open-label studies, positive results for chronic EAA supplementation in the elderly were reported for increased lean body mass (LBM) (16), leg strength (16), ...

Early Effect of Supplementation with Essential Amino Acids ...

After 6 months of supplementation with EAAs, we observed significant improvements in the parameters of sarcopenia. In addition, there was a significant ...

Amino Acids and Muscle Loss with Aging - PMC

For this reason, long-term essential amino acid supplementation may be a useful tool for the prevention and treatment of sarcopenia, particularly if excess ...

Higher Intake of Essential Amino Acids Associated with a ...

Specifically, the OR for high muscle strength was 2.17 times higher in the group with the highest total EAAS (Q4) than in the group with the ...

Effects of 12 Weeks of Essential Amino Acids (EAA)

The study demonstrate that a mixture with EAA, creatine, vitamin D and MRC® (ALA, CoQ10, resveratrol) may improve muscle aging-related outcomes, such as muscle ...

Dietary Essential Amino Acid Intake Is Associated with High ...

High muscle strength was significantly enhanced with increased total EAA intake from animal sources (OR: 1.27, 95% CI: 1.02–1.58), but there was no significant ...