Electrical Stimulation of Human Myocytes in Microgravity (microG)

June 6, 2025 updated by: AdventHealth Translational Research Institute

Electrical Stimulation of Human Myocytes in Microgravity: An In Vitro Model to Evaluate Therapeutics to Counteract Muscle Wasting (microG)

The purpose of this study is to evaluate the changes of muscle, in microgravity. Which will help explain the health benefits of exercise. There are tests that can be done to tell researchers more about the human body, such as a dual energy x-ray absorptiometry (DEXA) scan, which measures body composition (fat and lean body mass). The use of muscle testing and a Handgrip test can tell us about the strength and power within an individual's muscles. A VO2 max test helps us understand the aerobic fitness level of an individual and one of the most important aspects of this study are muscle cells. A muscle biopsy allows us to obtain muscle cells from the thigh, which will be sent into space by a rocket. Researchers will study these muscle cells in a low gravity environment aboard the International Space Station. Studying the muscle cells under those conditions will potentially mimic an accelerated aging process, which will help researchers better understand muscle wasting in the elderly.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32804
        • Translational Research Institute for Metabolism and Diabetes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Males and females in the age ranges 20-40 and 60-80 years were recruited. Participants were medically screened to determine good health, weight stable (less than 3kg weight change during the previous 6 months), and without any contraindication to exercise. Approximately equal numbers of men and women were be recruited. Neither race nor ethnicity were exclusions.

Description

Inclusion Criteria:

  • Participant is capable of giving informed consent and has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board and provided Health Insurance Portability and Accountability Act authorization (HIPAA) or other privacy authorization prior to any participation in study.
  • Participant is 20-40 or 60-80 years of age, inclusive
  • Participant BMI <30 kg/m2
  • Participant states willingness to follow protocol as described, including the prescribed activity level and completing any forms needed throughout the study.

Exclusion Criteria:

  • Participant reports a history of type 1 or type 2 Diabetes; or Hgb A1c > 6.5% at screening visit.
  • Participant is actively pursuing weight loss and/or lifestyle changes.
  • Participant has a history of pressure ulcers.
  • 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 poorly controlled hypertension or hypotension in the opinion of the study PI or medical investigator (MI).
  • Participant has untreated hypothyroidism or hyperthyroidism.
  • Participant has current infection (requiring prescription antimicrobial or antiviral medication, or hospitalization), or corticosteroid treatment (with the exception of inhaled or topical steroids) in the last 3 months prior to screening visit.
  • Participant is currently taking prescription strength anti-inflammatory medication or has taken prescription strength anti-inflammatory medication in the 6 weeks prior to screening.
  • Participant has had surgery requiring >2 days of hospitalization in the last 3 weeks prior to screening visit.
  • Participant has an active malignancy or autoimmune disease.
  • Participant has current significantly impaired liver function in the opinion of the study PI (mild asymptomatic fatty liver is acceptable), or hepatic enzyme tests are ≥2.5 times normal limit.
  • Participant has a chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV, per self-report.
  • Participant is an amputee and/or has presence of partial or full artificial limb.
  • 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.
  • Participant has a history of, or currently has uncontrolled severe diarrhea, nausea or vomiting.
  • Participant has an obstruction of the gastrointestinal tract, inflammatory bowel disease, short bowel syndrome or other forms of gastrointestinal disease such as stage III or above gastroesophageal reflux disease, gastroparesis, peptic ulcer disease, celiac disease, intestinal dysmotility, diverticulitis, ischemic colitis.
  • Participant has used tobacco within the last 3 months.
  • Participant has a history of drug or alcohol abuse (> 3 drinks per day) within the last 5 years
  • Female participant is pregnant, lactating or is within 6 weeks postpartum prior to the screening visit
  • Participant has impaired renal function: estimated glomerular filtration rate (eGFR) ≤ 50 ml/min/1.73m2 determined at screening.
  • Participant's triglyceride level is ≥ 250 mg/dl and LDL cholesterol is > 150 mg/dl at screening.
  • Participant has a urine albumin-to-creatinine ratio (UACR) ≥300 mg/g at screening in a single urine specimen (per National Kidney Foundation guideline).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Young adults
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.
Procedure: Muscle Tissue Biopsy
A biopsy of the Vastus Lateralis muscle will be performed on the left leg using the Bergstrom technique.The skin will be incised (approximately 0.75 cm) with a #11 scalpel, and the Bergstrom needle will be inserted into the Vastus Lateralis. Approximately 150 mg of muscle tissue will be obtained under suction. After the biopsy, pressure will be applied to stop bleeding and the skin will be closed with Steri strips (suture(s) if allergy to steri strips and removal 7-10 days post biopsy). A sterile dressing will be applied. Ace bandage may also be used along with applied pressure and an ice pack for any swelling and pain relief.
Other: Maximal Oxygen Consumption (V02max)
Aerobic fitness will be determined by measuring maximal O2 consumption (VO2max) during a stationary bicycle exercise test. Heart rate, blood pressure and ECG will be recorded throughout this test. Subjects will breathe through a low resistance mouthpiece and wear a nose clip. Expired gases will be measured by indirect calorimetry and heart rate monitored by a portable heart rate monitor. Following a standardized warm up, subjects will begin exercising at a moderate intensity with the workload increased every minute until the subject can no longer continue. A leveling-off (plateau) or decline in oxygen uptake should be demonstrated in order to be reasonably sure that a subject has achieved the maximum capacity for aerobic metabolism.
Older adults
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.
Procedure: Muscle Tissue Biopsy
A biopsy of the Vastus Lateralis muscle will be performed on the left leg using the Bergstrom technique.The skin will be incised (approximately 0.75 cm) with a #11 scalpel, and the Bergstrom needle will be inserted into the Vastus Lateralis. Approximately 150 mg of muscle tissue will be obtained under suction. After the biopsy, pressure will be applied to stop bleeding and the skin will be closed with Steri strips (suture(s) if allergy to steri strips and removal 7-10 days post biopsy). A sterile dressing will be applied. Ace bandage may also be used along with applied pressure and an ice pack for any swelling and pain relief.
Other: Maximal Oxygen Consumption (V02max)
Aerobic fitness will be determined by measuring maximal O2 consumption (VO2max) during a stationary bicycle exercise test. Heart rate, blood pressure and ECG will be recorded throughout this test. Subjects will breathe through a low resistance mouthpiece and wear a nose clip. Expired gases will be measured by indirect calorimetry and heart rate monitored by a portable heart rate monitor. Following a standardized warm up, subjects will begin exercising at a moderate intensity with the workload increased every minute until the subject can no longer continue. A leveling-off (plateau) or decline in oxygen uptake should be demonstrated in order to be reasonably sure that a subject has achieved the maximum capacity for aerobic metabolism.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle biopsy parameters
Time Frame: About 30 minutes
Collection of the muscle biopsy parameters (isolated satellite cells), from 9 participants in each of young and old study groups.
About 30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AdventHealth Translational Research Institute

Investigators

  • Principal Investigator: Paul Coen, PhD, Study Principal Investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2019

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

September 7, 2018

First Submitted That Met QC Criteria

September 7, 2018

First Posted (Actual)

September 11, 2018

Study Record Updates

Last Update Posted (Actual)

June 11, 2025

Last Update Submitted That Met QC Criteria

June 6, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRIMD 1311789

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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