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Exercise + Amino Acid Infusion for Obesity

N/A
Recruiting
Led By Lori R Roust, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Must not have
Uncontrolled metabolic disease, including renal disease
Diabetes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 hours on 2 separate days one month apart
Awards & highlights
No Placebo-Only Group

Summary

This trial will investigate how well exercise and amino acids can help improve protein homeostasis in people with obesity who have a distorted expression of myosin heavy chain protein.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include discomfort at the infusion site, allergic reactions to amino acids, muscle soreness from exercise routines, and possible gastrointestinal issues due to changes in metabolism.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any uncontrolled metabolic or kidney diseases.
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I have diabetes.
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I am currently experiencing a sudden illness.
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I have heart issues like irregular heartbeat, fainting, chest pain, or heart failure.
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I am not inactive or sedentary according to a recent activity survey.
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I have had surgery on my digestive system.
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I am not taking supplements that affect protein metabolism.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 hours on 2 separate days one month apart
This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 hours on 2 separate days one month apart for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Eukaryotic initiation factor 4F (eIF4F)
Change in Protein Synthesis
Change in messenger RNA (mRNA)
Secondary study objectives
Change in Protein breakdown

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Exercise, Infusion of Amino AcidsExperimental Treatment2 Interventions
Exercise followed by infusion of amino acids, or infusion of amino acids alone.
Group II: ExerciseActive Control1 Intervention
Exercise with no infusion of amino acids

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,362 Previous Clinical Trials
3,066,030 Total Patients Enrolled
87 Trials studying Obesity
9,040 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,464 Previous Clinical Trials
4,337,359 Total Patients Enrolled
472 Trials studying Obesity
590,920 Patients Enrolled for Obesity
Lori R Roust, MDPrincipal InvestigatorMayo Clinic
Christos S Katsanos, PhDPrincipal InvestigatorArizona State University
2 Previous Clinical Trials
117 Total Patients Enrolled
2 Trials studying Obesity
117 Patients Enrolled for Obesity

Media Library

Exercise Clinical Trial Eligibility Overview. Trial Name: NCT04700800 — N/A
Obesity Research Study Groups: Exercise, Infusion of Amino Acids, Exercise
Obesity Clinical Trial 2023: Exercise Highlights & Side Effects. Trial Name: NCT04700800 — N/A
Exercise 2023 Treatment Timeline for Medical Study. Trial Name: NCT04700800 — N/A
~11 spots leftby Jun 2025
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