~18 spots leftby Apr 2026

Threonine for Aging

Recruiting in Palo Alto (17 mi)
Glenda Courtney-Martin | Department of ...
Overseen byGlenda Courtney-Martin, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: The Hospital for Sick Children
No Placebo Group

Trial Summary

What is the purpose of this trial?

Threonine is an essential amino acid and must be obtained from the diet. The body's capacity to maintain adequate mucin synthesis is directly related to the bioavailability of certain amino acids, including threonine, serine and proline (1). Moreover, the rate of mucin synthesis has been demonstrated to be directly related to the availability of dietary threonine in healthy rats (2) and piglets (3,4). Intestinal inflammation is known to increase gastrointestinal threonine uptake and mucin synthesis in enterally fed minipigs (5). Additionally, in animals, mucin function/barrier has been shown to decline with age, leaving them more susceptible to bacterial penetration. Thus, with advancing age (6), a higher dietary supply of threonine may be needed for maintaining intestinal mucosal health. Despite this, the current threonine requirement is based on studies conducted exclusively in young adults. Thus, there is a need to determine the threonine requirement directly in older adults.

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

The trial requires that you do not take medications known to affect protein or amino acid metabolism, like steroids. If you're on such medications, you may need to stop them to participate.

What data supports the idea that Threonine for Aging is an effective treatment?

The available research does not provide direct evidence that Threonine is an effective treatment for aging. However, it highlights the importance of protein intake in the elderly. Studies show that higher protein consumption can help maintain muscle mass and strength, which are crucial for healthy aging. For example, one study suggests that elderly adults need more protein to achieve the same muscle health benefits as younger people. Another study indicates that low protein intake in older adults is linked to higher mortality risk, suggesting that adequate protein, including amino acids like Threonine, may be beneficial. While Threonine itself isn't specifically highlighted, the general emphasis on protein supports its potential role in aging.12345

What safety data exists for Threonine treatment?

The provided research does not specifically mention Threonine or its safety data. However, it highlights general concerns about adverse drug events (ADEs) and adverse drug reactions (ADRs) in older adults, emphasizing the importance of drug safety surveillance, especially in elderly populations. The studies discuss the challenges in detecting ADEs and ADRs, particularly in older adults, and the need for careful benefit-risk assessment and monitoring in this demographic. For specific safety data on Threonine, further targeted research or clinical trial data would be necessary.678910

Is the drug Threonine a promising treatment for aging?

The provided research articles do not directly discuss Threonine or its effects on aging. Therefore, based on the available information, we cannot conclude that Threonine is a promising treatment for aging.1112131415

Research Team

Glenda Courtney-Martin | Department of ...

Glenda Courtney-Martin, PhD

Principal Investigator

The Hospital for Sick Children

Eligibility Criteria

This trial is for healthy individuals aged 60 to 90 with a BMI under 30, not suffering from chronic diseases or acute illnesses that affect protein metabolism. Participants must not be on medications affecting protein/amino acid metabolism, have no significant recent weight loss or high caffeine/alcohol intake, and must be willing to undergo blood draws.

Inclusion Criteria

Fasting blood glucose, hemoglobin A1c (HbA1c), urea, creatinine
I am willing to participate in the study.
Consent provided
See 3 more

Exclusion Criteria

I am not willing to have blood drawn or undergo specific calorie measurement tests for this study.
Significant caffeine consumption (>2 cups per day)
I have a chronic illness or a recent sickness that can change how my body uses proteins.
See 4 more

Treatment Details

Interventions

  • Threonine (Amino Acid)
Trial OverviewThe study aims to determine the dietary requirement of threonine, an essential amino acid important for intestinal health, in older adults. It will assess whether people over age 60 need more threonine than younger adults do to maintain good digestive system function.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Threonine in Adults > 60Experimental Treatment1 Intervention
Threonine: all subjects will receive up to 7 threonine test levels, in random order.

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials
724
Recruited
6,969,000+
Dr. Ronald D. Cohn profile image

Dr. Ronald D. Cohn

The Hospital for Sick Children

Chief Executive Officer since 2019

MD from University of Düsseldorf, Germany

Dr. Lennox Huang profile image

Dr. Lennox Huang

The Hospital for Sick Children

Chief Medical Officer since 2016

MD from McGill University

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials
1,417
Recruited
26,550,000+

Dr. Paul C. Hébert

Canadian Institutes of Health Research (CIHR)

Chief Executive Officer

MD, University of Ottawa

Dr. Paul C. Hébert

Canadian Institutes of Health Research (CIHR)

Chief Medical Officer

MD, University of Ottawa

Findings from Research

In a study involving 12 older men, habituation to a high protein intake (>2.1 g/kg lean body mass per day) resulted in a higher fasting whole-body protein turnover but led to a lower net protein balance, indicating potential negative effects on protein retention.
Despite consuming a protein-rich meal after this high protein habituation, participants did not experience improved protein balance, suggesting that excessive protein intake may not enhance amino acid utilization in the elderly.
Impact of habituated dietary protein intake on fasting and postprandial whole-body protein turnover and splanchnic amino acid metabolism in elderly men: a randomized, controlled, crossover trial.Højfeldt, G., Bülow, J., Agergaard, J., et al.[2023]
Restriction of isoleucine in the diet improves metabolic health and promotes leanness and glycemic control in both young and old genetically diverse UM-HET3 mice, indicating its potential benefits for overall health.
Isoleucine restriction not only reduces frailty but also extends lifespan, particularly in male mice, suggesting that this dietary intervention could be a promising approach for enhancing healthspan and longevity.
Dietary restriction of isoleucine increases healthspan and lifespan of genetically heterogeneous mice.Green, CL., Trautman, ME., Chaiyakul, K., et al.[2023]
Low protein intake in mid-life (under 10% of calories) is linked to decreased mortality risk, but in individuals over 65, low protein intake is associated with increased mortality risk, highlighting the need for adequate protein in older adults.
Higher dietary protein may enhance health in the elderly by providing amino acids for glutathione synthesis, which protects against oxidative stress and inflammation; supplementation with N-acetylcysteine (NAC) and lipoic acid could further support this protective effect.
An increased need for dietary cysteine in support of glutathione synthesis may underlie the increased risk for mortality associated with low protein intake in the elderly.McCarty, MF., DiNicolantonio, JJ.[2022]

References

Impact of habituated dietary protein intake on fasting and postprandial whole-body protein turnover and splanchnic amino acid metabolism in elderly men: a randomized, controlled, crossover trial. [2023]
Dietary restriction of isoleucine increases healthspan and lifespan of genetically heterogeneous mice. [2023]
An increased need for dietary cysteine in support of glutathione synthesis may underlie the increased risk for mortality associated with low protein intake in the elderly. [2022]
Protein Consumption and the Elderly: What Is the Optimal Level of Intake? [2022]
Effects of branched-chain amino acids and vitamin D supplementation on physical function, muscle mass and strength, and nutritional status in sarcopenic older adults undergoing hospital-based rehabilitation: A multicenter randomized controlled trial. [2019]
A Computational Framework for Identifying Age Risks in Drug-Adverse Event Pairs. [2023]
Quantitative drug benefit-risk assessment: utility of modeling and simulation to optimize drug safety in older adults. [2018]
The out-of-focus bias in drug surveillance. [2021]
Use of triggers tools to search for adverse drug reactions in the elderly admitted to emergency departments. [2019]
Strategies for detecting adverse drug events among older persons in the ambulatory setting. [2018]
11.United Statespubmed.ncbi.nlm.nih.gov
Protein modification in aging. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Taurine linked with healthy aging. [2023]
Proteomics in aging research: A roadmap to clinical, translational research. [2022]
Methionine oxidation and aging. [2016]
Respiratory chain cysteine and methionine usage indicate a causal role for thiyl radicals in aging. [2013]