The Effects of Whole Body Unloading on Physiological Function

NCT03195348 | Completed

• 1 other identifier: 206237
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a collaboration between the Centre of Human \& Aerospace Physiological Sciences (CHAPS) and the Sleep and Brain Plasticity Centre (Department of Neuroimaging) at King's College London and the Sleep Disorders Centre at Guy's Hospital.The main purpose of the study is to evaluate the effects of a 7 day unloading period (simulating micro gravity) on muscle mass using three independent methods; two scanning techniques (magnetic resonance imaging (MRI) and dual x-ray absorptiometry (DXA)) and one that involves swallowing a capsule that contains a harmless chemical called creatine (D3-Creatine (D3-cr)) and then measuring its concentration in urine. In order to induce muscle loss, participants will be required to lie flat on their back on a water bed filled with water and salt (called hyper-buoyancy flotation (HBF)). As this situation is similar to that experienced in space, the investigators will also measure the effect of HBF on sleep, brain and physiological function - all things known to change in astronauts. Sixteen male subjects (18-40 yrs) will be recruited to participate in the study that will require physiological testing before, during and following both 7 days of normal conditions and 7 days of HBF bed-rest. Each subject will be exposed to the same conditions and assessments over the study period. As some loss of muscle is expected, participants will be offered an exercise rehabilitation programme upon completion of HBF with self-monitored and/or guided sessions based on those provided by the Space Medicine Office of the European Space Agency to returning astronauts.

Conditions

Muscle Atrophy; Weightlessness; Sleep Disturbance; Astronaut-Bone Demineralisation Syndrome

Outcome Measures

Primary Outcomes (1)

• Whole body skeletal muscle loss

  The primary aim of this study is to investigate whole body skeletal muscle loss induced through 7 consecutive days of HBF using three independent methods; dual x-ray absorptiometry (DXA), magnetic resonance imaging (MRI) and D3-Creatine dilution (D3-cr)

  7 days

Secondary Outcomes (13)

• Regional differences in muscle loss

  7 days

• Relationship between change in total skeletal muscle mass and rectus femoris cross sectional area

  7 days

• Central nervous system changes induced by 7-day HBF

  7 days

• Myofiber cross-sectional area changes with unloading compared with quadriceps cross sectional area

  7 days

• Muscle biochemistry

  7 days

Study Arms (1)

HBF Bed Rest

EXPERIMENTAL

7 days control period followed by a washout period, then 7 days of HBF.

Other: HBF Bed Rest

Interventions

HBF Bed Rest OTHER

7 days of bed rest on hyper-buoyancy floatation (HBF)

HBF Bed Rest

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males aged 18-40
• No clinically significant and relevant abnormalities in medical history
• Absence of any condition that could affect subject safety or well-being or their ability to understand and follow study procedures and requirements
• Absence of any condition which has/will result in irregular regulation of skeletal muscle, creatine metabolism or reduction of total skeletal muscle mass
• Absence of a medical history that includes back pain

You may not qualify if:

• Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
• Habitual use (\>twice a week) of creatine supplementation within 6 weeks of the study
• Previous history of smoking
• No known current or past neurological or psychiatric co-morbidities, no known sleep abnormalities (e.g. insomnia, snoring, sleep apnoea, sleep-walking/talking, nocturnal panic attacks, restless leg syndrome)
• Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit
• Relation of any study investigators, personnel at the study site or employee of any of the study sponsors
• Any kind of medication prior to 1 month of screening
• Recent history (within the last 1 year) of alcohol or other substance abuse
• A previous history of nosebleeds

Sponsors & Collaborators

• King's College London: lead
• Guy's and St Thomas' NHS Foundation Trust: collaborator

Study Sites (1)

Sleep Disorders Centre

London, United Kingdom

Location

MeSH Terms

Conditions

Muscular Atrophy; Parasomnias

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Sleep Wake Disorders; Mental Disorders

Study Officials

• Ivana Rosenzweig, PhD

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: June 22, 2017
• Study Start: March 29, 2017
• Primary Completion: August 30, 2017
• Study Completion: August 30, 2017
• Last Updated: October 31, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)