Body Weight Changes Clinical Trial
— NUCOfficial title:
The Effect of Potassium Bicarbonate on Bone and the Immune System During 21 Days of 6° Head- Down- Tilt Bedrest (HDT- Bedrest)
Verified date | February 2017 |
Source | DLR German Aerospace Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 8 |
Est. completion date | October 2010 |
Est. primary completion date | October 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 20 Years to 45 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Germany | German Aerospace Centre (DLR) | Cologne |
Lead Sponsor | Collaborator |
---|---|
DLR German Aerospace Center | European Space Agency, University of Aarhus, University of Trieste |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The reduction of the immobilisation induced bone loss by supplementing an alkaline salt (potassium bicarbonate) | 21 days of HDT- Bedrest | ||
Secondary | Influence of KHCO3 on bone mass, bone mineral density and bone strength | 21 days of HDT- Bedrest | ||
Secondary | Determination of effects of KHCO3 on muscle strength, muscle power and muscle volume | 21 days of HDT- Bedrest | ||
Secondary | Determine the effects of KHCO3 on body composition and body weight | 21 days of HDT- Bedrest | ||
Secondary | Determine the effects of KHCO3 on the cardiovascular system | 21 days of HDT- Bedrest | ||
Secondary | Determine the effects of KHCO3 on the neuro- vestibular system | 21 days of HDT- Bedrest | ||
Secondary | Determination of effects of KHCO3 on protein and muscle turnover | 21 days of HDT- Bedrest |
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