Changes in Acid Base Status During High Salt Intake (SL8)
Primary Purpose
Low Grade Metabolic Acidosis
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
High NaCl + KHCO3
Control: high NaCl
Sponsored by
About this trial
This is an interventional basic science trial for Low Grade Metabolic Acidosis
Eligibility Criteria
Inclusion Criteria:
- healthy males
- 19 - 35 years
- 65 - 85kg
- 170 - 190 cm
- successfully completed psychological and medical screening
Exclusion Criteria:
- athletes
- smoking
- drug- or alcohol abuse
- hyperlipidemia
- renal diseases
- obesity
- anemia
- bone diseases
- diabetes
- rheumatism
- blood donation within three month prior to study start
- participation in another clinical investigation three month prior to study start
Sites / Locations
- German Aerospace Center (DLR)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Campaign 1
Campaign 2
Arm Description
Outcomes
Primary Outcome Measures
Change in daily urinary C- and N-terminal bone collagen telopeptides (mmol/d)
Secondary Outcome Measures
Serum concentration of bone specific alkaline phosphatase (microg/L)
Daily Nitrogen balance (g/d)
Free cortisol excretion in 24h urine (microg/d)
Phenylalanine hydroxylation (micromol/min)
Systolic blood pressure (bpm)
24h urinary net acid excretion (mEq/d)
Serum concentration of N-terminal propeptide Type I (mmol/L)
Free cortisone excretion in 24h urine (microg/d)
Protein synthesis (micromol/min)
Protein degradation (micromol/min)
Diastolic blood pressure (bpm)
Capillary pH
Capillary HCO3- Concentration (mmol/L)
Capillary Base excess (mmol/L)
Capillary pCO2 (mmHg)
Capillary pO2 (mmHg)
Full Information
NCT ID
NCT01655953
First Posted
July 23, 2012
Last Updated
August 1, 2012
Sponsor
DLR German Aerospace Center
Collaborators
Charite University, Berlin, Germany, University of Erlangen-Nürnberg
1. Study Identification
Unique Protocol Identification Number
NCT01655953
Brief Title
Changes in Acid Base Status During High Salt Intake
Acronym
SL8
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DLR German Aerospace Center
Collaborators
Charite University, Berlin, Germany, University of Erlangen-Nürnberg
4. Oversight
5. Study Description
Brief Summary
The study aimed to examine the effects of an alkalinisation of a NaCl (sodium chloride, salt)-rich diet on acid base status, bone metabolism, protein turnover and other influenced physiological systems. Due to increased urinary calcium excretion and bone resorption a high NaCl-intake is considered as a risk factor for osteoporosis. On the contrary an alkaline diet is known to have a beneficial influence on bone metabolism. Therefore the investigators hypothesized that an alkaline diet can reduce NaCl-induced bone resorption.
8 healthy male volunteers took part in a stationary study carried out in the metabolic ward of the German Aerospace Center. The study consisted of 2 campaigns, each lasting 16 days. Both campaigns were divided into 5 days of adaptation, 10 days of intervention and 1.5 days of stationary recovery. During the intervention period the volunteers diet was NaCl-rich (7.7 mmol Na/kg body weight/day) and supplemented in one campaign by 90 mmol potassium bicarbonate (KHCO3) in a randomized cross-over design. The other campaign served as control.
Bone metabolism was studied by bone formation markers in the fasting morning blood and 24h-urinary bone resorption markers. Acid base status was assessed by blood gas analyses in the fasted and the postprandial state as well as urinary markers. Protein turnover was studied with stable isotopes. Further physiological systems like energy metabolism and the cardiovascular system are also under investigation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Grade Metabolic Acidosis
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
Campaign 1
Arm Type
Experimental
Arm Title
Campaign 2
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
High NaCl + KHCO3
Intervention Description
7.7 mmol Na/kgBW/d + 90 mmol KHCO3
Intervention Type
Other
Intervention Name(s)
Control: high NaCl
Intervention Description
7.7 mmol Na/kgBW/d
Primary Outcome Measure Information:
Title
Change in daily urinary C- and N-terminal bone collagen telopeptides (mmol/d)
Time Frame
Daily for a duration of 16 days
Secondary Outcome Measure Information:
Title
Serum concentration of bone specific alkaline phosphatase (microg/L)
Time Frame
Baseline, after 3, 6, 8, 10 days of intervention, 2 days after finishing the intervention
Title
Daily Nitrogen balance (g/d)
Time Frame
Daily for a duration of 16 days
Title
Free cortisol excretion in 24h urine (microg/d)
Time Frame
Baseline, after 3, 6, 10 days of intervention
Title
Phenylalanine hydroxylation (micromol/min)
Time Frame
Baseline, end of intervention
Title
Systolic blood pressure (bpm)
Time Frame
Daily for a duration of 16 days
Title
24h urinary net acid excretion (mEq/d)
Time Frame
Baseline, end of intervention
Title
Serum concentration of N-terminal propeptide Type I (mmol/L)
Time Frame
Baseline, after 3, 6, 8, 10 days of intervention, 2 days after finishing intervention
Title
Free cortisone excretion in 24h urine (microg/d)
Time Frame
Baseline, after 3, 6, 10 days of intervention
Title
Protein synthesis (micromol/min)
Time Frame
Baseline, end of intervention
Title
Protein degradation (micromol/min)
Time Frame
Baseline, end of intervention
Title
Diastolic blood pressure (bpm)
Time Frame
Daily for a duration of 16 days
Title
Capillary pH
Time Frame
Baseline, after 3, 6, 8, 10 days of intervention, 2 days after finishing intervention
Title
Capillary HCO3- Concentration (mmol/L)
Time Frame
Baseline, after 3, 6, 8, 10 days of intervention, 2 days after finishing intervention
Title
Capillary Base excess (mmol/L)
Time Frame
Baseline, after 3, 6, 8, 10 days of intervention, 2 days after finishing intervention
Title
Capillary pCO2 (mmHg)
Time Frame
Baseline, after 3, 6, 8, 10 days of intervention, 2 days after finishing intervention
Title
Capillary pO2 (mmHg)
Time Frame
Baseline, after 3, 6, 8, 10 days of intervention, 2 days after finishing intervention
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy males
19 - 35 years
65 - 85kg
170 - 190 cm
successfully completed psychological and medical screening
Exclusion Criteria:
athletes
smoking
drug- or alcohol abuse
hyperlipidemia
renal diseases
obesity
anemia
bone diseases
diabetes
rheumatism
blood donation within three month prior to study start
participation in another clinical investigation three month prior to study start
Facility Information:
Facility Name
German Aerospace Center (DLR)
City
Cologne
ZIP/Postal Code
51147
Country
Germany
12. IPD Sharing Statement
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Changes in Acid Base Status During High Salt Intake
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