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The Effect of Potassium Bicarbonate on Bone and Several Physiological Systems During Immobilisation (NUC)

Primary Purpose

Bone Diseases, Metabolic, Acid-Base Imbalance, Muscular Atrophy

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Potassium Bicarbonate
Sponsored by
DLR German Aerospace Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Bone Diseases, Metabolic focused on measuring bone metabolism, potassium bicarbonate, alkaline salt, acid base balance, bed rest

Eligibility Criteria

20 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • German Aerospace Centre (DLR)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Potassium Bicarbonate

Control

Arm Description

Outcomes

Primary Outcome Measures

The reduction of the immobilisation induced bone loss by supplementing an alkaline salt (potassium bicarbonate)

Secondary Outcome Measures

Influence of KHCO3 on bone mass, bone mineral density and bone strength
Determination of effects of KHCO3 on muscle strength, muscle power and muscle volume
Determine the effects of KHCO3 on body composition and body weight
Determine the effects of KHCO3 on the cardiovascular system
Determine the effects of KHCO3 on the neuro- vestibular system
Determination of effects of KHCO3 on protein and muscle turnover

Full Information

First Posted
July 4, 2011
Last Updated
February 28, 2017
Sponsor
DLR German Aerospace Center
Collaborators
University of Trieste, University of Aarhus, European Space Agency
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1. Study Identification

Unique Protocol Identification Number
NCT01509456
Brief Title
The Effect of Potassium Bicarbonate on Bone and Several Physiological Systems During Immobilisation
Acronym
NUC
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 Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DLR German Aerospace Center
Collaborators
University of Trieste, University of Aarhus, European Space Agency

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Diseases, Metabolic, Acid-Base Imbalance, Muscular Atrophy, Sprains and Strains, Protein Metabolism, Body Weight Changes, Cardiovascular Abnormalities
Keywords
bone metabolism, potassium bicarbonate, alkaline salt, acid base balance, bed rest

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Potassium Bicarbonate
Arm Type
Active Comparator
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Potassium Bicarbonate
Intervention Description
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
Primary Outcome Measure Information:
Title
The reduction of the immobilisation induced bone loss by supplementing an alkaline salt (potassium bicarbonate)
Time Frame
21 days of HDT- Bedrest
Secondary Outcome Measure Information:
Title
Influence of KHCO3 on bone mass, bone mineral density and bone strength
Time Frame
21 days of HDT- Bedrest
Title
Determination of effects of KHCO3 on muscle strength, muscle power and muscle volume
Time Frame
21 days of HDT- Bedrest
Title
Determine the effects of KHCO3 on body composition and body weight
Time Frame
21 days of HDT- Bedrest
Title
Determine the effects of KHCO3 on the cardiovascular system
Time Frame
21 days of HDT- Bedrest
Title
Determine the effects of KHCO3 on the neuro- vestibular system
Time Frame
21 days of HDT- Bedrest
Title
Determination of effects of KHCO3 on protein and muscle turnover
Time Frame
21 days of HDT- Bedrest

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisca May, Dr.
Organizational Affiliation
German Aerospace Centre, Institute of Aerospace Medicine (DLR)
Official's Role
Principal Investigator
Facility Information:
Facility Name
German Aerospace Centre (DLR)
City
Cologne
ZIP/Postal Code
51147
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
30255228
Citation
Frings-Meuthen P, Bernhardt G, Buehlmeier J, Baecker N, May F, Heer M. The negative effect of unloading exceeds the bone-sparing effect of alkaline supplementation: a bed rest study. Osteoporos Int. 2019 Feb;30(2):431-439. doi: 10.1007/s00198-018-4703-6. Epub 2018 Sep 25.
Results Reference
derived

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The Effect of Potassium Bicarbonate on Bone and Several Physiological Systems During Immobilisation

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