Low Grade Metabolic Acidosis Clinical Trial
— SL8| Verified date | July 2012 |
| Source | DLR German Aerospace Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Ethics Commission |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 8 |
| Est. completion date | August 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 19 Years to 35 Years |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| Germany | German Aerospace Center (DLR) | Cologne |
| Lead Sponsor | Collaborator |
|---|---|
| DLR German Aerospace Center | Charite University, Berlin, Germany, University of Erlangen-Nürnberg |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in daily urinary C- and N-terminal bone collagen telopeptides (mmol/d) | Daily for a duration of 16 days | No | |
| Secondary | Serum concentration of bone specific alkaline phosphatase (microg/L) | Baseline, after 3, 6, 8, 10 days of intervention, 2 days after finishing the intervention | No | |
| Secondary | Daily Nitrogen balance (g/d) | Daily for a duration of 16 days | No | |
| Secondary | Free cortisol excretion in 24h urine (microg/d) | Baseline, after 3, 6, 10 days of intervention | No | |
| Secondary | Phenylalanine hydroxylation (micromol/min) | Baseline, end of intervention | No | |
| Secondary | Systolic blood pressure (bpm) | Daily for a duration of 16 days | No | |
| Secondary | 24h urinary net acid excretion (mEq/d) | Baseline, end of intervention | No | |
| Secondary | Serum concentration of N-terminal propeptide Type I (mmol/L) | Baseline, after 3, 6, 8, 10 days of intervention, 2 days after finishing intervention | No | |
| Secondary | Free cortisone excretion in 24h urine (microg/d) | Baseline, after 3, 6, 10 days of intervention | No | |
| Secondary | Protein synthesis (micromol/min) | Baseline, end of intervention | No | |
| Secondary | Protein degradation (micromol/min) | Baseline, end of intervention | No | |
| Secondary | Diastolic blood pressure (bpm) | Daily for a duration of 16 days | No | |
| Secondary | Capillary pH | Baseline, after 3, 6, 8, 10 days of intervention, 2 days after finishing intervention | No | |
| Secondary | Capillary HCO3- Concentration (mmol/L) | Baseline, after 3, 6, 8, 10 days of intervention, 2 days after finishing intervention | No | |
| Secondary | Capillary Base excess (mmol/L) | Baseline, after 3, 6, 8, 10 days of intervention, 2 days after finishing intervention | No | |
| Secondary | Capillary pCO2 (mmHg) | Baseline, after 3, 6, 8, 10 days of intervention, 2 days after finishing intervention | No | |
| Secondary | Capillary pO2 (mmHg) | Baseline, after 3, 6, 8, 10 days of intervention, 2 days after finishing intervention | No |