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Changes in Acid Base Status During High Salt Intake

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01655953
Acronym
SL8
Enrollment
8
Registered
2012-08-02
Start date
2007-07-31
Completion date
2007-08-31
Last updated
2012-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Grade Metabolic Acidosis

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.

Interventions

DIETARY_SUPPLEMENTHigh NaCl + KHCO3

7.7 mmol Na/kgBW/d + 90 mmol KHCO3

OTHERControl: high NaCl

7.7 mmol Na/kgBW/d

Sponsors

Charite University, Berlin, Germany
CollaboratorOTHER
University of Erlangen-Nürnberg
CollaboratorOTHER
DLR German Aerospace Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
19 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Change in daily urinary C- and N-terminal bone collagen telopeptides (mmol/d)Daily for a duration of 16 days

Secondary

MeasureTime frame
Systolic blood pressure (bpm)Daily for a duration of 16 days
24h urinary net acid excretion (mEq/d)Baseline, end of intervention
Serum concentration of bone specific alkaline phosphatase (microg/L)Baseline, after 3, 6, 8, 10 days of intervention, 2 days after finishing the intervention
Daily Nitrogen balance (g/d)Daily for a duration of 16 days
Free cortisol excretion in 24h urine (microg/d)Baseline, after 3, 6, 10 days of intervention
Serum concentration of N-terminal propeptide Type I (mmol/L)Baseline, after 3, 6, 8, 10 days of intervention, 2 days after finishing intervention
Free cortisone excretion in 24h urine (microg/d)Baseline, after 3, 6, 10 days of intervention
Phenylalanine hydroxylation (micromol/min)Baseline, end of intervention
Protein degradation (micromol/min)Baseline, end of intervention
Diastolic blood pressure (bpm)Daily for a duration of 16 days
Capillary pHBaseline, after 3, 6, 8, 10 days of intervention, 2 days after finishing intervention
Capillary HCO3- Concentration (mmol/L)Baseline, after 3, 6, 8, 10 days of intervention, 2 days after finishing intervention
Capillary Base excess (mmol/L)Baseline, after 3, 6, 8, 10 days of intervention, 2 days after finishing intervention
Capillary pCO2 (mmHg)Baseline, after 3, 6, 8, 10 days of intervention, 2 days after finishing intervention
Capillary pO2 (mmHg)Baseline, after 3, 6, 8, 10 days of intervention, 2 days after finishing intervention
Protein synthesis (micromol/min)Baseline, end of intervention

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026