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 range
20 Years – 45 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The reduction of the immobilisation induced bone loss by supplementing an alkaline salt (potassium bicarbonate)