Electrical Stimulation for Sarcopenia

(microG Trial)

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Translational Research Institute for Metabolism and Diabetes, Florida
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to study how muscle changes in a low-gravity environment, like space, can enhance understanding of muscle loss, especially in older adults. Researchers will send muscle samples from participants to the International Space Station to observe their reactions without gravity, simulating rapid aging. The trial involves two groups: young adults and older adults, each providing muscle samples for research. Individuals who have maintained a steady weight and do not have diabetes or certain other health issues might be suitable candidates.

As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on muscle health in space.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking prescription strength anti-inflammatory medication, you must not have taken it in the 6 weeks prior to screening.

What prior data suggests that this electrical stimulation method is safe for muscle cells?

Research has shown that electrical stimulation is generally safe for people. Previous studies found that it can safely improve muscle strength and function. Common side effects are mild and may include slight skin irritation where the electrodes are placed.

In this study, a muscle biopsy involves taking a small piece of muscle tissue. This routine medical procedure is considered safe, though it might cause temporary soreness or bruising at the sample site.

The study includes both young and older adults to observe how their muscles respond to electrical stimulation. Past research with similar groups has not reported any major safety issues. Overall, the evidence suggests that the treatment is safe for participants.

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring a novel way to combat sarcopenia, a condition characterized by muscle loss often seen in older adults. Traditional treatments for sarcopenia typically involve exercise, nutritional supplements, and sometimes medications that promote muscle growth. However, this approach is different because it involves developing a millifluidic chip designed to electrically stimulate muscle cells. This technology could potentially enhance muscle regeneration and strength by directly activating muscle tissues in a controlled manner, which is a fresh angle compared to existing methods. If successful, it may offer a more efficient and targeted way to reverse muscle loss and improve quality of life for those affected.

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

Research has shown that electrical stimulation can improve muscle strength and function. Other studies have found it can also increase muscle size and power in individuals with conditions like sarcopenia that cause muscle loss. This trial will collect muscle biopsy specimens from both young and older adults to develop a millifluidic chip for electrical stimulation of human primary muscle cell hydrogel cultures. This treatment sends small electrical signals to muscles, causing them to contract and strengthen over time. Early findings suggest that even without movement, this stimulation can help maintain muscle mass and slow muscle loss. Although research continues, these early results offer hope that electrical stimulation might effectively combat muscle loss in older adults.

Who Is on the Research Team?

PC

Paul Coen, PhD

Principal Investigator

Study Principal Investigator

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am willing to follow the study's rules and complete all required forms.
You weigh less than 30 kilograms for every square meter of your height.
I have signed the consent form and agreed to share my health information for this study.
See 1 more

Exclusion Criteria

I have a history of blood clots or a condition that increases my risk for clots.
You have had an amputation or use a partial or full artificial limb.
My liver function is significantly impaired, or my liver tests are more than 2.5 times the normal limit.
See 19 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Muscle Biopsy and Testing

Muscle biopsy specimens are obtained from participants and various tests such as DEXA scan, muscle testing, Handgrip test, and VO2 max test are conducted.

1-2 weeks

Microgravity Experimentation

Muscle cells obtained from biopsies are sent to the International Space Station for study in a microgravity environment.

Duration not specified

Follow-up

Participants are monitored for any post-biopsy effects and overall health status.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Maximal Oxygen Consumption (V02max)
  • Muscle Tissue Biopsy
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Young adultsExperimental Treatment2 Interventions
Group II: Older adultsExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Translational Research Institute for Metabolism and Diabetes, Florida

Lead Sponsor

Trials
41
Recruited
3,600+

AdventHealth Translational Research Institute

Lead Sponsor

Trials
51
Recruited
5,900+

Citations

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