Exercise + Amino Acid Infusion for Obesity

Overseen By Lori R Roust

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Prescription drugs, OTC drugs

Disqualifiers: Diabetes, Heart disease, Liver disease, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 month

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how exercise and amino acid infusions (intravenous amino acids) affect muscle protein metabolism in people with obesity. Researchers are particularly interested in how these treatments might help correct issues with specific muscle proteins linked to obesity-related health problems. Participants will either exercise followed by amino acid infusions, receive only the infusions, or exercise without infusions. Individuals with a BMI of 32-50, who are currently inactive, and do not take medications or supplements affecting protein metabolism might be a good fit for this trial. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could improve health outcomes for individuals with obesity.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any prescription or over-the-counter medications, as well as supplements that affect protein metabolism, to participate in this trial.

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

Previous studies have shown that exercise is safe and beneficial for people with obesity. Regular exercise reduces body fat and improves overall health. It lowers the risk of heart disease, type 2 diabetes, and some cancers. Active individuals tend to live longer.

Research indicates that most amino acid supplements are generally safe for humans, with little evidence of serious side effects. However, some supplements may cause mild side effects. Amino acid infusions are often used safely for nutritional support, especially in medical settings.

Both exercise and amino acid infusions are well-tolerated by most people. Always consult a healthcare provider before starting any new treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about combining exercise with amino acid infusions for obesity because it offers a fresh approach to tackling weight issues. Unlike traditional methods like diet, exercise alone, or medications, this treatment uses amino acid infusions to potentially enhance muscle recovery and growth, which might lead to increased fat burning. The unique aspect is the infusion itself, which directly delivers essential nutrients, possibly boosting the effectiveness of exercise. This combination could offer a new way to manage obesity more efficiently and effectively than current options.

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

This trial will compare the effects of exercise combined with amino acid infusions to exercise alone. Studies have shown that this combination can help muscles in people with obesity use amino acids more efficiently, potentially improving protein processing in muscles. Research also indicates that while insulin struggles to manage certain amino acids in people with type 2 diabetes, it works better in those with obesity. This suggests potential benefits for addressing health issues related to obesity. Importantly, researchers have found no major safety concerns with this treatment combination. ^{6 7 8 9 10}

Who Is on the Research Team?

Christos S Katsanos, PhD

Principal Investigator

Arizona State University

Lori R Roust, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults with obesity, having a BMI of 32-50 kg/m2. They must be able to consent to the study and should not have acute illnesses, liver or severe heart disease, low blood counts, recent steroid use, extreme diets like veganism, or be on weight-loss regimens. Smokers and pregnant individuals are excluded.

Inclusion Criteria

Body mass index (BMI), 18-26 kg/m2 (lean subjects), 32-50 kg/m2 (subjects with obesity)

Ability to sign informed consent form

Exclusion Criteria

I do not have any uncontrolled metabolic or kidney diseases.

I have not used anabolic steroids or corticosteroids in the last 3 months.

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo exercise and/or amino acid infusion to evaluate changes in muscle protein metabolism

1 month

2 visits (in-person)

Follow-up

Participants are monitored for changes in muscle protein synthesis and breakdown after interventions

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exercise
• Infusion of Amino Acids

Trial Overview The trial investigates how exercise combined with amino acid infusions affects muscle protein regulation in obese individuals. It aims to understand how these interventions can correct protein imbalances linked to poor health outcomes in obesity.

How Is the Trial Designed?

Group I: Subjects with obesity Experimental Treatment 1 Intervention

Exercise followed by infusion of amino acids

Group II: Lean Subjects Active Control 1 Intervention

Exercise followed by infusion of amino acids

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

In a study involving obese prediabetic ZDF rats, swimming exercise significantly reduced elevated plasma concentrations of essential amino acids and altered protein metabolism without affecting food intake or weight gain.

The exercise improved hyperglycemia independently of body weight changes, suggesting that it may help regulate blood sugar levels by modulating muscle AKT activation and systemic amino acid metabolism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise in ZDF rats does not attenuate weight gain, but prevents hyperglycemia concurrent with modulation of amino acid metabolism and AKT/mTOR activation in skeletal muscle. Adegoke, OA., Bates, HE., Kiraly, MA., et al.[2021]

In a 12-week study involving 35 overweight adults, both medium (1,500 mg/d) and low (750 mg/d) doses of an amino acid mixture showed potential in reducing abdominal fat compared to a placebo, with the medium dose resulting in a notable average reduction of -25.3 cm² in total abdominal fat area.

No adverse events were reported during the trial, indicating that the amino acid mixture is safe for use in conjunction with physical activity promotion, but further research with a larger sample size is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose-ranging pilot randomized trial of amino acid mixture combined with physical activity promotion for reducing abdominal fat in overweight adults. Sasai, H., Ueda, K., Tsujimoto, T., et al.[2022]

In a study involving 20 male Sprague-Dawley rats, exercise as an adjunct to parenteral nutrition did not significantly affect nitrogen balance or body weight compared to nonexercised rats, indicating that exercise alone may not enhance overall recovery in this context.

However, exercised rats showed a 15% decrease in plasma amino acids but a 66% increase in muscle amino acids, suggesting that exercise stimulates amino acid turnover in muscle, which may support energy metabolism and protein synthesis without altering nitrogen balance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of exercise on postoperative nitrogen balance. Freund, H., Yoshimura, N., Fischer, JE.[2017]

Branched-chain amino acid (BCAA) solutions may help normalize amino acid levels in patients with hepatic encephalopathy, but controlled trials show little impact on clinical outcomes, especially in acute liver failure or liver transplantation.

Amino acid infusions can enhance ventilatory drive, but they also carry risks of side effects like acidosis and hyperammonemia, highlighting the need for careful use and further research into their effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

General and specialized parenteral amino acid formulations for nutrition support. Heyman, MB.[2006]

Amino acids, particularly leucine and its metabolite HMB, play a crucial role in activating mTORC1, which enhances protein synthesis in skeletal muscle, highlighting their importance in muscle health and recovery.

Supplementation with β-alanine has been shown to improve physical performance and cognitive function in middle-aged individuals, suggesting potential benefits for aging populations and athletes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regulation of Skeletal Muscle Function by Amino Acids, Especially Non-Proteinogenic Amino Acids. Sugimoto, T., Kamei, Y.[2022]

In a study involving 26 brain-dead patients, the infusion of amino acid solutions did not lead to an increase in energy expenditure or thermogenesis, suggesting that these effects may be absent in this population.

The findings indicate a potential central pathway that regulates energy expenditure and thermogenesis, as predicted energy expenditure was higher than resting energy expenditure, but no significant metabolic changes were observed during the amino acid infusion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thermogenic and metabolic response to amino acid solution in brain-dead patients. Cankayali, I., Demirağ, K., Kocabaş, S., et al.[2015]

Consuming an essential amino acid-carbohydrate supplement (EAC) immediately before resistance exercise leads to a significantly greater increase in muscle protein synthesis compared to taking it after exercise, as shown in a study with six healthy participants.

The study found that amino acid delivery to the muscles was higher during and immediately after exercise when the EAC was consumed before the workout, resulting in a total net phenylalanine uptake of 209 mg compared to 81 mg when taken after exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Timing of amino acid-carbohydrate ingestion alters anabolic response of muscle to resistance exercise. Tipton, KD., Rasmussen, BB., Miller, SL., et al.[2022]

In a study involving 20 postoperative coronary bypass patients and 6 healthy volunteers, both balanced amino acid and BCAA-enriched solutions increased resting energy expenditure (REE), with the BCAA solution showing a significantly higher thermogenic response in patients (46.9% vs. 28.5%).

Healthy volunteers only experienced an increase in REE with the balanced amino acid solution, indicating that BCAAs may have a lower energy cost for metabolism and less thermogenic effect compared to balanced amino acids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Branched-chain and mixed amino acid solutions and thermogenesis in postoperative patients. Pitkänen, O., Takala, J., Pöyhönen, M., et al.[2004]

In a study involving six healthy male volunteers, supplementation with L-phenylalanine before exercise significantly increased plasma glycerol and glucagon levels, indicating enhanced fat mobilization during physical activity.

The results suggest that taking L-phenylalanine prior to exercise may promote fat oxidation without any serious side effects, making it a potentially effective strategy for improving fat loss during workouts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of phenylalanine on exercise-induced fat oxidation: a preliminary, double-blind, placebo-controlled, crossover trial. Ueda, K., Sanbongi, C., Yamaguchi, M., et al.[2022]

Citations

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About Physical Activity Active people generally live longer and are at less risk for serious health problems such as heart disease, type 2 diabetes, obesity, and some cancers.