The primary objective is to evaluate the effectiveness of dietary nitrate in reducing muscle atrophy induced by bedrest. Secondary objectives include assessing its impact on insulin resistance, muscle strength, and cardiovascular function.…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Niet een aandoening, maar inactiviteit en de complicaties die daarbij komen kijken.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the change in leg skeletal muscle volume (measured by
MRI) before and after bedrest.
Secondary outcome
Secondary endpoints include whole-body insulin sensitivity, muscle protein
synthesis rates, mitochondrial respiration, aerobic capacity, muscle strength,
blood flow, arterial stiffness, cardiac function, and endothelial function.
Background summary
Physical inactivity due to bedrest has significant negative health impacts,
including rapid muscle mass loss, loss in muscle strength, insulin resistance,
and impaired cardiac function. This study aims to investigate whether dietary
nitrate supplementation can mitigate these adverse cardiometabolic effects
during bedrest.
Study objective
The primary objective is to evaluate the effectiveness of dietary nitrate in
reducing muscle atrophy induced by bedrest. Secondary objectives include
assessing its impact on insulin resistance, muscle strength, and cardiovascular
function. Additionally, the study seeks to identify cellular mechanisms
affecting peripheral metabolism during bedrest.
Study design
This is a single, prospective randomized study. Thirty-two healthy individuals
aged 18-40 years will participate. They will be randomly assigned to receive
either dietary nitrate or a placebo during a 7-day bedrest period. The study
includes pre- and post-bedrest assessments.
Intervention
Participants will be randomly assigned to receive either nitrate supplements
(1097 mg NaNO3 in 140 mL water, providing 800 mg nitrate) or a placebo (1097 mg
NaCl in 140 mL water) twice daily during bedrest.
Study burden and risks
Participants will visit the university five times over 15 consecutive days.
These visits include one screening session (~1 hour), three testing days (each
~2.75, 5, 1 hours, respectively), a 7-day bedrest period, and one final test
day (~2.75 hours). Procedures include metabolic rate assessments, VO2max
testing, muscle strength testing, MRI scans, blood draws, muscle biopsies, and
various cardiovascular and metabolic measurements. Risks are minimal and
primarily involve temporary discomfort from blood draws and biopsies, possible
mild gastrointestinal distress from nitrate supplements, and potential muscle
soreness from VO2max testing. Participants will contribute to scientific
knowledge that could inform future nutritional interventions to improve health
and recovery in physically inactive populations.
Universiteitssingel 50
Maastricht 6229 ER
NL
Universiteitssingel 50
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
• Aged between 18 and 40 y inclusive
• BMI between 18.8 and 30 kg/m2
Exclusion criteria
• Vegetarian/vegan
• Having any food allergies related to the diets that are provided (we will
provide the list of food items during the screening to assess this with the
volunteers)
• Smoking on a weekly basis (i.e. every week)
• Diagnosed GI tract disorders or diseases
• Diagnosed musculoskeletal disorders
• Diagnosed metabolic disorders (e.g., diabetes)
• Donated blood 2 months prior to the trial
• (Family) history of thrombosis
• Back complaints
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL87477.068.24 |