Countermeasure EvaluationMEPNCT01655979
Medium-term Bedrest Whey Protein (MEP)
A study testing Whey Protein + Potassium bicarbonate in people with Countermeasure Evaluation, run by DLR German Aerospace Center at 1 site in Germany.
Trial summary
The human being has shown that he can live and work in the space environment, but due to the lack of essential mechanical load on muscle and bone, the fluid-shift as well as alterations in the acid-base balance (mainly on account of nutritional factors), the exposure to microgravity results in a gradual degradation of… Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Countermeasure Evaluation
- What is being tested?
- Whey Protein + Potassium bicarbonate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2011to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males, 20 -45 years
- BMI: 20 - 25 kg/m2
- Height: 158 - 190 cm
- Weight: 65 - 85 kg
- maximum relative oxygen uptake: 30 - 60 ml/min/kg
- non-smokers
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- successful medical and psychological screening
- Willingness to participate in the entire study
- signed informed consent
- social insurance
- Clear criminal background check
Who cannot join
- Abuse of drugs, medicine or alcohol
- Vegetarians, Vegans
- Migraines
- History of mental illness
- Claustrophobia
- History of: thyroid dysfunction, renal stones, diabetes, allergies, hypertension, hypocalcaemia, uric acidaemia, lipidaemia, hyperhomocysteinaemia
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
The human being has shown that he can live and work in the space environment, but due to the lack of essential mechanical load on muscle and bone, the fluid-shift as well as alterations in the acid-base balance (mainly on account of nutritional factors), the exposure to microgravity results in a gradual degradation of muscle, bone and cartilage, deconditioning of the cardiovascular system and metabolic changes. Countermeasures to prevent all the deconditioning of the physiological systems are not yet fully effective and require further investigation.
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.
Read more
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.
- Conditions
- Countermeasure Evaluation
- Being tested
- Whey Protein + Potassium bicarbonate, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey Protein + Potassium bicarbonateDietary supplement
0.6 mmol WP/kg body weight + 90 mmol KHCO3 during bed rest
ControlOther
Bed rest without dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| MEP-1 | Experimental | Not described Receives: Dietary Supplement: Whey Protein + Potassium bicarbonate; Other: Control |
| MEP-2 | Experimental | Not described Receives: Dietary Supplement: Whey Protein + Potassium bicarbonate; Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body composition
Measured: Baseline, after 21 days of bed rest
Secondary outcomes (29)
Plasma Volume
Measured: Baseline, after 21 days of bed rest
Maximum volume of oxygen uptake
Measured: Baseline, after 21 days of bed rest
Isometric torque
During a an Isometric Maximum Voluntary Contraction Test on the knee extensors \& flexors, the plantarflexors and dorsiflexors, the elbow extensors \& flexors the Isometric Torque will be measured in Nm.
Measured: Baseline, after 21 days of bed rest
Muscle fatigue
Measured: Baseline, after 21 days of bed rest
Bone metabolism
Measured: Baseline, after 2,5,14,21 days of bed rest, 1, 5, 14, 28 days after finishing bed rest
Bone mineral density + content
Measured: Baseline, after 21 days of bed rest
Standing balance
Measured: Baseline, after 21 days of bed rest
Locomotion
Locomotion will be assessed by Dynamic Gait Index, specific parameters are: total Score and Subscore
Measured: Baseline, after 21 days of bed rest
Body mass
Measured: Daily for a duration of 35 days
Intracranial pressure
Measured: Baseline, after 1,4, 7,10,13,14,15,16,17,18,19,20,21 days of bed rest,1,2,4 days after finishing bed rest
Monitoring of Vitamin K status
Measured: Baseline, after 2,5,14,21 days of bed rest, 1, 5 days after finishing bed rest
Fat metabolism
Measured: Baseline, after 21 days of bed rest
Glucose metabolism
Measured: Baseline, after 21 days of bed rest, 4 days after finishing bed rest
Nitrogen balance
Measured: Daily for a duration of 33 days
Energy metabolism
Measured: Baseline, after 21 days of bed rest
Glucocorticoid activity
Measured: Baseline, after 2,3,7,8,12,13,16,17 days of bed rest, 2,3 days after finishing bed rest
Muscle metabolism
Measured: Baseline, after 21 days of bed rest
Acid base balance
Measured: Baseline, after 2, 14, 21 days of bed rest, 5 days after finishing bed rest
Sympathetic activity during orthostatic stress
Muscle sympathetic nerve activity is measured by MSNA recording by microneurography technique.
Measured: Baseline, after 21 days of bed rest
Visual Orientation
Visual Orientation is assessed by 'Oriented Character Recognition Test' and Luminous Line Test. The main parameter is Score.
Measured: Baseline, after 6,12,20 days of bed rest, 2,4 days after finishing bed rest
Plasma galanin and adrenomedullin responses during head up tilt test (orthostatic stress)
Measured: Baseline, after 21 days of bed rest
Cartilage metabolism and -thickness
Measured: Baseline, after 2,3,5,7,14,21 days of bed rest, 5 days after finishing bed rest
Hematopoetic system
Blood cell count, reticulocytes, Haptoglobin, Bilirubin, Ferritin, EPO, Thrombopoietin, Urinary Urobilinogen and Fecal Urobilinogen (markers of blood cell degradation)
Measured: Baseline, after 10, 21 days of bed rest, 1, 28 days after finishing bed rest
Fat accumulation in bone marrow
Measured: Baseline, after 10, 21 days of bed rest, 3, 28 days after finishing bed rest
Achilles tendon structure
Measured: Baseline, after 21 days of bed rest, 2, 28 days after finishing bed rest
Headache - frequency and quality
Measured: Baseline, daily during 21 days of bed rest
Muscle volume
Measured: Baseline, after 20, 21 days of bed rest, 3 days after finishing bed rest
Free water and fat content in muscle
Measured: Baseline, after 20, 21 days of bed rest, 3 days after finishing bed rest
Orthostatic tolerance
Orthostatic tolerance will be assessed by Head up tilt test. The following parameters are assessed to measure orthostatic tolerance: beat-to-beat heart rate [bpm], beat-to-beat blood pressure [bpm] time to presyncope [min, s]
Measured: Baseline, after 21 days of bed rest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2012 (estimated)
- Study startAug 2011
- Primary completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Countermeasure EvaluationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- DLR German Aerospace Center
- Sponsor type
- University, hospital or other
- Collaborators
- European Space Agency, University Hospital, Clermont-Ferrand, Institut Pluridisciplinaire Hubert Curien, Strasbourg, France, Charite University, Berlin, Germany, University of Milan, Université de Nice Sophia Antipolis, University of Ottawa, Manchester Metropolitan University, University of Toronto, Medical University of Graz, University of Cologne, Radboud University Medical Center, University Hospital, Lille, Leiden University Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01655979
- Sponsor's protocol ID
- ESA-AO-06-BR
- Acronym
- MEP
- Status last verified
- Jul 2012
- First submitted
- 23 Jul 2012
- Last updated
- 2 Aug 2012
- Results posted
- No
Publications
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.
PubMed 29546280
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medium-term Bedrest Whey Protein (MEP)
- ClinicalTrials.gov ID
- NCT01655979
- Acronym / sponsor ID
- MEP / ESA-AO-06-BR
- Conditions
- Countermeasure Evaluation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- DLR German Aerospace CenterUniversity, hospital or other
- Collaborators
- European Space Agency, University Hospital, Clermont-Ferrand, Institut Pluridisciplinaire Hubert Curien, Strasbourg, France, Charite University, Berlin, Germany, University of Milan, Université de Nice Sophia Antipolis, University of Ottawa, Manchester Metropolitan University, University of Toronto, Medical University of Graz, University of Cologne, Radboud University Medical Center, University Hospital, Lille, Leiden University Medical Center
- Study start
- Aug 2011
- Primary completion
- Apr 2012 (actual)
- First posted
- 2 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The human being has shown that he can live and work in the space environment, but due to the lack of essential mechanical load on muscle and bone, the fluid-shift as well as alterations in the acid-base balance (mainly on account of nutritional factors), the exposure to microgravity results in a gradual degradation of muscle, bone and cartilage, deconditioning of the cardiovascular system and metabolic changes. Countermeasures to prevent all the deconditioning of the physiological systems are not yet fully effective and require further investigation.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MEP-1 | Experimental | Dietary Supplement: Whey Protein + Potassium bicarbonate, Other: Control |
| MEP-2 | Experimental | Dietary Supplement: Whey Protein + Potassium bicarbonate, Other: Control |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Healthy males, 20 -45 years
- BMI: 20 - 25 kg/m2
- Height: 158 - 190 cm
- Weight: 65 - 85 kg
- maximum relative oxygen uptake: 30 - 60 ml/min/kg
Key exclusion criteria (25 listed)
- Abuse of drugs, medicine or alcohol
- Vegetarians, Vegans
- Migraines
- History of mental illness
- Claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whey Protein + Potassium bicarbonate0.6 mmol WP/kg body weight + 90 mmol KHCO3 during bed rest | Dietary supplement | MEP-1, MEP-2 |
| ControlBed rest without dietary supplement | Other | MEP-1, MEP-2 |
Primary outcome
Change in body composition
Time frame: Baseline, after 21 days of bed rest
29 secondary outcomes
Plasma Volume
Time frame: Baseline, after 21 days of bed rest
Maximum volume of oxygen uptake
Time frame: Baseline, after 21 days of bed rest
Isometric torque
Time frame: Baseline, after 21 days of bed rest
Muscle fatigue
Time frame: Baseline, after 21 days of bed rest
Bone metabolism
Time frame: Baseline, after 2,5,14,21 days of bed rest, 1, 5, 14, 28 days after finishing bed rest
Bone mineral density + content
Time frame: Baseline, after 21 days of bed rest
Standing balance
Time frame: Baseline, after 21 days of bed rest
Locomotion
Time frame: Baseline, after 21 days of bed rest
Body mass
Time frame: Daily for a duration of 35 days
Intracranial pressure
Time frame: Baseline, after 1,4, 7,10,13,14,15,16,17,18,19,20,21 days of bed rest,1,2,4 days after finishing bed rest
Monitoring of Vitamin K status
Time frame: Baseline, after 2,5,14,21 days of bed rest, 1, 5 days after finishing bed rest
Fat metabolism
Time frame: Baseline, after 21 days of bed rest
Glucose metabolism
Time frame: Baseline, after 21 days of bed rest, 4 days after finishing bed rest
Nitrogen balance
Time frame: Daily for a duration of 33 days
Energy metabolism
Time frame: Baseline, after 21 days of bed rest
Glucocorticoid activity
Time frame: Baseline, after 2,3,7,8,12,13,16,17 days of bed rest, 2,3 days after finishing bed rest
Muscle metabolism
Time frame: Baseline, after 21 days of bed rest
Acid base balance
Time frame: Baseline, after 2, 14, 21 days of bed rest, 5 days after finishing bed rest
Sympathetic activity during orthostatic stress
Time frame: Baseline, after 21 days of bed rest
Visual Orientation
Time frame: Baseline, after 6,12,20 days of bed rest, 2,4 days after finishing bed rest
Plasma galanin and adrenomedullin responses during head up tilt test (orthostatic stress)
Time frame: Baseline, after 21 days of bed rest
Cartilage metabolism and -thickness
Time frame: Baseline, after 2,3,5,7,14,21 days of bed rest, 5 days after finishing bed rest
Hematopoetic system
Time frame: Baseline, after 10, 21 days of bed rest, 1, 28 days after finishing bed rest
Fat accumulation in bone marrow
Time frame: Baseline, after 10, 21 days of bed rest, 3, 28 days after finishing bed rest
Achilles tendon structure
Time frame: Baseline, after 21 days of bed rest, 2, 28 days after finishing bed rest
Headache - frequency and quality
Time frame: Baseline, daily during 21 days of bed rest
Muscle volume
Time frame: Baseline, after 20, 21 days of bed rest, 3 days after finishing bed rest
Free water and fat content in muscle
Time frame: Baseline, after 20, 21 days of bed rest, 3 days after finishing bed rest
Orthostatic tolerance
Time frame: Baseline, after 21 days of bed rest
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2012.
- Derived from this study: PubMed 29546280Rudwill 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey Protein + Potassium bicarbonate in people with Countermeasure Evaluation, run by DLR German Aerospace Center at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body composition (time frame: Baseline, after 21 days of bed rest). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01655979, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2012.