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Medium-term Bedrest Whey Protein (MEP)

G

German Aerospace Center (DLR)

Status

Completed

Conditions

Countermeasure Evaluation

Treatments

Other: Control
Dietary Supplement: Whey Protein + Potassium bicarbonate

Study type

Interventional

Funder types

Other

Identifiers

NCT01655979
ESA-AO-06-BR

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

Male

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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
  • successful medical and psychological screening
  • Willingness to participate in the entire study
  • signed informed consent
  • social insurance
  • Clear criminal background check

Exclusion criteria

  • 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
  • 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 design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

10 participants in 2 patient groups

MEP-1
Experimental group
Treatment:
Other: Control
Dietary Supplement: Whey Protein + Potassium bicarbonate
MEP-2
Experimental group
Treatment:
Other: Control
Dietary Supplement: Whey Protein + Potassium bicarbonate

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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