The Effect of Potassium Bicarbonate on Bone and Several Physiological Systems During Immobilisation (NCT01509456) | Clinical Trial Compass
CompletedNot Applicable
The Effect of Potassium Bicarbonate on Bone and Several Physiological Systems During Immobilisation
Germany8 participantsStarted 2010-02
Plain-language summary
Mainly due to the absence of gravitational forces in weightlessness, astronauts suffer from an increased bone loss- negatively affecting health and vitality during a mission. The development of effective countermeasures to this loss includes many different aspects like sports but also nutrition.
Alkaline salts, abundant in fruits and vegetables, have shown to have positive effects on markers of bone turnover of postmenopausal women but also men and younger adults. With the current study the effects of a potassium bicarbonate supplementation added to a standardised, strictly controlled, definite diet of healthy, young men, should be verified within 21 days of 6°- HDT- Bedrest- the gold standard of simulating weightlessness within earthbound conditions.
Who can participate
Age range20 Years – 45 Years
SexMALE
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Inclusion Criteria:
* healthy male subjects
* age: 20- 45
* weight 65- 85 kg
* height: 158- 190 cm
* BMI 20- 26 kg/m2
* no high performance sports
* non- smoking (minimum 6 months prior to study start)
* willing to complete both parts of the study
* presentation of social security and criminal record
* successful completion of medical and psychological screening
* signed informed consent
Exclusion Criteria:
* drugs- and alcohol abuse
* antiinflammatory drugs taken during the study
* vegetarianism, veganism
* migraine
* psychical illness in the past
* claustrophobia
* hiatal hernia
* gastroesophageal reflux
* diabetes mellitus
* Rheumatic disease
* muscle or joint disease
* disc prolapse
* orthostatic intolerance
* Hyperlipidaemia
* renal disease
* thyroid dysfunction
* hyperhomocysteinaemia
* hyper-/hypouremia
* hyper-/hypocalcemia
* anaemia
* hypoferremia
* Vitamin D deficiency
* deviation of blood gases from normal values (pH 7,38 - 7,42; pO2 79 - 98 mmHg; pCO2 34 - 45 mmHg; HCO3 20 - 28 mmol/l; Base excess ± 2 mmol/l)
* risk of thrombosis
* chronic back pain
* bone fracture within one year prior to study start
* bone mineral density 1,5 SD ≤ t-Score
* metal implants or other osteosynthesis material
* subject within another clinical trial within 2 months prior to study start
* any other status which according to the apprehension of the principal investigator leads to the exclusion of the subject
What they're measuring
1
The reduction of the immobilisation induced bone loss by supplementing an alkaline salt (potassium bicarbonate)