- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01655953
Changes in Acid Base Status During High Salt Intake (SL8)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cologne, Germany, 51147
- German Aerospace Center (DLR)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Campaign 1
|
7.7 mmol Na/kgBW/d + 90 mmol KHCO3
7.7 mmol Na/kgBW/d
|
Experimental: Campaign 2
|
7.7 mmol Na/kgBW/d + 90 mmol KHCO3
7.7 mmol Na/kgBW/d
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in daily urinary C- and N-terminal bone collagen telopeptides (mmol/d)
Time Frame: Daily for a duration of 16 days
|
Daily for a duration of 16 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Baseline, after 3, 6, 8, 10 days of intervention, 2 days after finishing the intervention
|
Daily Nitrogen balance (g/d)
Time Frame: Daily for a duration of 16 days
|
Daily for a duration of 16 days
|
Free cortisol excretion in 24h urine (microg/d)
Time Frame: Baseline, after 3, 6, 10 days of intervention
|
Baseline, after 3, 6, 10 days of intervention
|
Phenylalanine hydroxylation (micromol/min)
Time Frame: Baseline, end of intervention
|
Baseline, end of intervention
|
Systolic blood pressure (bpm)
Time Frame: Daily for a duration of 16 days
|
Daily for a duration of 16 days
|
24h urinary net acid excretion (mEq/d)
Time Frame: Baseline, end of intervention
|
Baseline, end of intervention
|
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
|
Baseline, after 3, 6, 8, 10 days of intervention, 2 days after finishing intervention
|
Free cortisone excretion in 24h urine (microg/d)
Time Frame: Baseline, after 3, 6, 10 days of intervention
|
Baseline, after 3, 6, 10 days of intervention
|
Protein synthesis (micromol/min)
Time Frame: Baseline, end of intervention
|
Baseline, end of intervention
|
Protein degradation (micromol/min)
Time Frame: Baseline, end of intervention
|
Baseline, end of intervention
|
Diastolic blood pressure (bpm)
Time Frame: Daily for a duration of 16 days
|
Daily for a duration of 16 days
|
Capillary pH
Time Frame: Baseline, after 3, 6, 8, 10 days of intervention, 2 days after finishing intervention
|
Baseline, after 3, 6, 8, 10 days of intervention, 2 days after finishing intervention
|
Capillary HCO3- Concentration (mmol/L)
Time Frame: Baseline, after 3, 6, 8, 10 days of intervention, 2 days after finishing intervention
|
Baseline, after 3, 6, 8, 10 days of intervention, 2 days after finishing intervention
|
Capillary Base excess (mmol/L)
Time Frame: Baseline, after 3, 6, 8, 10 days of intervention, 2 days after finishing intervention
|
Baseline, after 3, 6, 8, 10 days of intervention, 2 days after finishing intervention
|
Capillary pCO2 (mmHg)
Time Frame: Baseline, after 3, 6, 8, 10 days of intervention, 2 days after finishing intervention
|
Baseline, after 3, 6, 8, 10 days of intervention, 2 days after finishing intervention
|
Capillary pO2 (mmHg)
Time Frame: Baseline, after 3, 6, 8, 10 days of intervention, 2 days after finishing intervention
|
Baseline, after 3, 6, 8, 10 days of intervention, 2 days after finishing intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DLR Salty Life 8 Study
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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