Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2011-08-31
Brief Summary
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A commonly utilized model of simulating the physiological effects of microgravity on the human organism on ground is the 6° head-down-tilt bed rest. In the present study the model has been used to study potential countermeasures to spaceflight-associated deconditioning.
One of the most constrictive changes appearing during space flight as well as during bed rest, are disuse-induced muscle losses. These are associated with a decrease in muscle protein synthesis, rather then an increase in muscle protein breakdown. Besides an effective training countermeasure, nutritional countermeasures gain respect in this context: supplementing conventional diets with whey protein or essential amino acids has been shown to increase muscle protein synthesis. Due to these anabolic properties whey protein seems promising to counteract disuse-induced muscle wasting.
Drawbacks of a high protein intake are calciuric effects, ascribed to the proton-release when metabolizing sulfur-containing amino acids. The so called 'low grade metabolic acidosis' has also shown to activate osteoclastic bone resorption and muscle protein degradation. Therefore, to maximize the anabolic potential of a whey protein supplementation, the acidogenic properties need to be compensated. As previous works suggest, a shift of acid base balance into the acid direction and the resulting changes in bone and protein turnover may be hindered by supplementing alkaline mineral salts.
In this regard, a mid-term bed rest study was performed in order to investigate the effect of a combined whey protein (0.6 g/kg body weight/day) and potassium bicarbonate (90 mmol/day) supplementation as a potential countermeasure to multiple physiological and metabolic alterations on the human body resulting from real and simulated microgravity.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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MEP-1
Whey Protein + Potassium bicarbonate
0.6 mmol WP/kg body weight + 90 mmol KHCO3 during bed rest
Control
Bed rest without dietary supplement
MEP-2
Whey Protein + Potassium bicarbonate
0.6 mmol WP/kg body weight + 90 mmol KHCO3 during bed rest
Control
Bed rest without dietary supplement
Interventions
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Whey Protein + Potassium bicarbonate
0.6 mmol WP/kg body weight + 90 mmol KHCO3 during bed rest
Control
Bed rest without dietary supplement
Eligibility Criteria
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Inclusion Criteria
* BMI: 20 - 25 kg/m2
* Height: 158 - 190 cm
* Weight: 65 - 85 kg
* maximum relative oxygen uptake: 30 - 60 ml/min/kg
* non-smokers
* successful medical and psychological screening
* Willingness to participate in the entire study
* signed informed consent
* social insurance
* Clear criminal background check
Exclusion Criteria
* Vegetarians, Vegans
* Migraines
* History of mental illness
* Claustrophobia
* History of: thyroid dysfunction, renal stones, diabetes, allergies, hypertension, hypocalcaemia, uric acidaemia, lipidaemia, hyperhomocysteinaemia
* Rheumatism
* Muscle-, Cartilage- or Joint Injuries
* Gastro-esophageal reflux disease, renal function disorder, Hiatus hernia
* Chronic back pain
* Bone diseases
* Herniated discs
* Achilles tendon injuries
* Cruciate ligament rupture or any other severe knee injury
* BMD more than 1.5 SD \< t-score
* History of orthostatic intolerance or vestibular disorders
* Anaemia
* Vitamin D Deficiency
* Positive response in thrombosis screening
* Use of metallic implants, osteosynthesis material
* Porphyria, Blood dyscrasia
* HIV, Hepatitis
* Increased Inner Eye pressure
* Intolerance to local anesthetics
* Participation in another study up to three month before study onset
20 Years
45 Years
MALE
Yes
Sponsors
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European Space Agency
OTHER
University Hospital, Clermont-Ferrand
OTHER
Institut Pluridisciplinaire Hubert Curien, Strasbourg, France
UNKNOWN
Charite University, Berlin, Germany
OTHER
University of Milan
OTHER
Université de Nice Sophia Antipolis
OTHER
University of Ottawa
OTHER
Manchester Metropolitan University
OTHER
University of Toronto
OTHER
Medical University of Graz
OTHER
University of Cologne
OTHER
Radboud University Medical Center
OTHER
University Hospital, Lille
OTHER
Leiden University Medical Center
OTHER
DLR German Aerospace Center
OTHER
Responsible Party
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Locations
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DLR German Aerospace Center
Cologne, , Germany
Countries
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References
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Rudwill F, O'Gorman D, Lefai E, Chery I, Zahariev A, Normand S, Pagano AF, Chopard A, Damiot A, Laurens C, Hodson L, Canet-Soulas E, Heer M, Meuthen PF, Buehlmeier J, Baecker N, Meiller L, Gauquelin-Koch G, Blanc S, Simon C, Bergouignan A. Metabolic Inflexibility Is an Early Marker of Bed-Rest-Induced Glucose Intolerance Even When Fat Mass Is Stable. J Clin Endocrinol Metab. 2018 May 1;103(5):1910-1920. doi: 10.1210/jc.2017-02267.
Other Identifiers
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ESA-AO-06-BR
Identifier Type: -
Identifier Source: org_study_id