The Effect of Potassium Bicarbonate on Bone and Several Physiological Systems During Immobilisation (NUC)
|ClinicalTrials.gov Identifier: NCT01509456|
Recruitment Status : Completed
First Posted : January 13, 2012
Last Update Posted : March 1, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Bone Diseases, Metabolic Acid-Base Imbalance Muscular Atrophy Sprains and Strains Protein Metabolism Body Weight Changes Cardiovascular Abnormalities||Dietary Supplement: Potassium Bicarbonate||Not Applicable|
Astronauts in space suffer from an increased bone loss which is mainly related to the absence of gravitational forces. This increased bone reduction is accompanied by an higher concentration of calcium in urine and in this respect enhancing the risk of renal stones. Due to the fact, that bones´ regeneration does not occur rapidly even after returning to earth, astronauts face an increased risk of osteoporosis.
Nutritional factors such as a deficient intake of calcium, energy and fluid and the abundant intake of table salt exhibit additional negative effects on bone. Results of several studies consistently show the negative effects of acids on bone (increased bone loss). With respect to space missions of longer duration one big challenge is the development of countermeasures for the negative consequences of weightlessness on bone.
As not all needed experiments for the development of countermeasures can be conducted in space, simulation models of weightlessness such as 6° Head- Down- Tilt- Bedrest (HDT- Bedrest) have been implemented on earth, miming some physiological conditions of weightlessness such as unloading and immobilisation of the lower parts of the body and the fluid shift.
Alkaline salts, such as potassium bicarbonate (KHCO3), demonstrate positive effects on bone when being supplemented to postmenopausal women. Apart from the positive effects on markers of bone turnover, calcium concentration in urine could be reduced. Thus, the main aim of the present study was to reduce the immobilization induced bone resorption through an alkalizing effect of the alkaline salt KHCO3`s supplementation during Head- Down- Tilt- Bedrest (HDT- Bedrest)-a leading simulation model of weightlessness.
The crossover designed study consisted of two parts of equal length (36 days)- 7 days of adaptation, 21 days of HDT- Bedrest, 6 days recovery and 2 days of long- term follow- up. Both study parts only differed in the HDT- period, where one group of the 8 healthy, young, male participating subjects was supplemented with 90 mmol KHCO3 daily (3 times a day 30 mmol KHCO3 diluted in 200 ml tab water, supplemented together with the main meals), while the other group only received 200 ml of tab water without any supplementation (Control group).
The measurements of bone formation markers as well as bone resorption markers in blood and urine supply insight into the influences of the supplementation on bone metabolism while blood gas analysis together with the pH- values of the 24h- urine point out the alkalising effects of KHCO3. Further physiological systems like protein and muscle metabolism, body weight and body composition, circulation and the neuro- vestibular system are simultaneously under investigation.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||The Effect of Potassium Bicarbonate on Bone and the Immune System During 21 Days of 6° Head- Down- Tilt Bedrest (HDT- Bedrest)|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||October 2010|
|Active Comparator: Potassium Bicarbonate||
Dietary Supplement: Potassium Bicarbonate
90 mmol daily, effervescent tablets 30 mmol diluted in 200 ml tab water supplemented three times a day together with the main meals for 21 days of HDT- bedrest
|No Intervention: Control|
- The reduction of the immobilisation induced bone loss by supplementing an alkaline salt (potassium bicarbonate) [ Time Frame: 21 days of HDT- Bedrest ]
- Influence of KHCO3 on bone mass, bone mineral density and bone strength [ Time Frame: 21 days of HDT- Bedrest ]
- Determination of effects of KHCO3 on muscle strength, muscle power and muscle volume [ Time Frame: 21 days of HDT- Bedrest ]
- Determine the effects of KHCO3 on body composition and body weight [ Time Frame: 21 days of HDT- Bedrest ]
- Determine the effects of KHCO3 on the cardiovascular system [ Time Frame: 21 days of HDT- Bedrest ]
- Determine the effects of KHCO3 on the neuro- vestibular system [ Time Frame: 21 days of HDT- Bedrest ]
- Determination of effects of KHCO3 on protein and muscle turnover [ Time Frame: 21 days of HDT- Bedrest ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01509456
|German Aerospace Centre (DLR)|
|Cologne, Germany, 51147|
|Principal Investigator:||Francisca May, Dr.||German Aerospace Centre, Institute of Aerospace Medicine (DLR)|