Electrical Stimulation of Human Myocytes in Microgravity

NCT03665051 | Active Not Recruiting

• 1 other identifier: TRIMD 1311789
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (1)

• Muscle biopsy parameters

  Collection of the muscle biopsy parameters (isolated satellite cells), from 9 participants in each of young and old study groups.

  About 30 minutes

Study Arms (2)

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; Other: Maximal Oxygen Consumption (V02max)

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; Other: Maximal Oxygen Consumption (V02max)

Interventions

Muscle Tissue Biopsy PROCEDURE

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.

Older adults; Young adults

Maximal Oxygen Consumption (V02max) OTHER

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; Young adults

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AdventHealth Translational Research Institute: lead

Study Sites (1)

Translational Research Institute for Metabolism and Diabetes

Orlando, Florida, 32804, United States

Location

Related Publications (22)

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Related Links

• Translational Research Institute for Metabolism and Diabetes

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Paul Coen, PhD

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2018
• First Posted: September 11, 2018
• Study Start: January 25, 2019
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)