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Electrical Stimulation for Sarcopenia (microG Trial)

N/A

Waitlist Available

Led By Paul Coen, PhD

Research Sponsored by Translational Research Institute for Metabolism and Diabetes, Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Participant has a stated history of Deep Vein Thrombosis (DVT), recent (within last 3 months) pulmonary embolism, or has a positive D-dimer test and lower extremity ultrasound at screening, or a known hypercoagulable condition, or other clotting or bleeding disorders.

Participant has had a significant cardiovascular event (e.g. myocardial infarction, stroke) ≤ 6 months prior to screening visit; or stated history of congestive heart failure; or participant has evidence of cardiovascular disease assessed during the ECG at screening.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up about 30 minutes

Awards & highlights

No Placebo-Only Group

Summary

This trialwill study how muscle changes in zero gravity to understand the health benefits of exercise. Tests measure body composition, strength, and aerobic fitness, and muscle cells are sent to the ISS for research.

Who is the study for?

This trial is for healthy adults aged 20-40 or 60-80 with a BMI under 30, able to consent and follow the study protocol. Excluded are those actively changing their lifestyle for weight loss, with severe uncontrolled symptoms like diarrhea, high/low blood pressure, recent surgery or hospitalization, infectious diseases (e.g., HIV), pregnant/lactating women postpartum within 6 weeks, tobacco users in the last three months, diabetics or those with clotting disorders.

What is being tested?

The study tests how muscle cells from thigh biopsies behave in microgravity aboard the International Space Station. It aims to simulate accelerated aging and understand muscle wasting. Participants undergo body composition scans (DEXA), strength tests (Handgrip test), aerobic fitness assessments (VO2 max test), and provide muscle tissue samples.

What are the potential side effects?

Potential side effects include discomfort at biopsy site on thigh and risks associated with VO2 max testing such as shortness of breath or fatigue during exercise. DEXA scans have minimal risk but involve low-level radiation exposure.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of blood clots or a condition that increases my risk for clots.

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I have had a major heart event or have heart failure within the last 6 months.

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I have an active cancer or autoimmune disease.

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I am currently on, or have recently taken, prescription anti-inflammatory medication.

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I have a serious gastrointestinal condition.

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My kidney function is reduced with an eGFR of 50 ml/min/1.73m2 or less.

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I have had pressure ulcers in the past.

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I was hospitalized for more than 2 days due to surgery within the last 3 weeks.

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I have diabetes or my Hgb A1c level was over 6.5% during screening.

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I currently suffer from, or have a history of severe uncontrolled diarrhea, nausea, or vomiting.

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I have a chronic infectious disease like TB, Hepatitis B/C, or HIV.

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I have untreated thyroid issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ about 30 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~about 30 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and about 30 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Muscle biopsy parameters

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

Group I: Young adultsExperimental Treatment2 Interventions

Obtain muscle biopsy specimens from young adults (ages 20-40) to develop a millifluidic chip for electrical stimulation of human primary muscle cell hydrogel cultures.

Group II: Older adultsExperimental Treatment2 Interventions

Obtain muscle biopsy specimens from older adults (ages 60-80) to develop a millifluidic chip for electrical stimulation of human primary muscle cell hydrogel cultures.

0 / 12Eligibility criteria met