Low Grade Metabolic AcidosisSL8NCT01655953
Changes in Acid Base Status During High Salt Intake
A study testing High NaCl + KHCO3 in people with Low Grade Metabolic Acidosis, run by DLR German Aerospace Center at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Low Grade Metabolic Acidosis
- What is being tested?
- High NaCl + KHCO3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2007to Aug 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy males
- 19 - 35 years
- 65 - 85kg
- 170 - 190 cm
- successfully completed psychological and medical screening
Who cannot join
- athletes
- smoking
- drug- or alcohol abuse
- hyperlipidemia
- renal diseases
- obesity
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Low Grade Metabolic Acidosis
- Being tested
- High NaCl + KHCO3, Control: high NaCl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High NaCl + KHCO3Dietary supplement
7.7 mmol Na/kgBW/d + 90 mmol KHCO3
Control: high NaClOther
7.7 mmol Na/kgBW/d
| Study group | Role | What they receive |
|---|---|---|
| Campaign 1 | Experimental | Not described Receives: Dietary Supplement: High NaCl + KHCO3; Other: Control: high NaCl |
| Campaign 2 | Experimental | Not described Receives: Dietary Supplement: High NaCl + KHCO3; Other: Control: high NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in daily urinary C- and N-terminal bone collagen telopeptides (mmol/d)
Measured: Daily for a duration of 16 days
Secondary outcomes (16)
Serum concentration of bone specific alkaline phosphatase (microg/L)
Measured: Baseline, after 3, 6, 8, 10 days of intervention, 2 days after finishing the intervention
Daily Nitrogen balance (g/d)
Measured: Daily for a duration of 16 days
Free cortisol excretion in 24h urine (microg/d)
Measured: Baseline, after 3, 6, 10 days of intervention
Phenylalanine hydroxylation (micromol/min)
Measured: Baseline, end of intervention
Systolic blood pressure (bpm)
Measured: Daily for a duration of 16 days
24h urinary net acid excretion (mEq/d)
Measured: Baseline, end of intervention
Serum concentration of N-terminal propeptide Type I (mmol/L)
Measured: Baseline, after 3, 6, 8, 10 days of intervention, 2 days after finishing intervention
Free cortisone excretion in 24h urine (microg/d)
Measured: Baseline, after 3, 6, 10 days of intervention
Protein synthesis (micromol/min)
Measured: Baseline, end of intervention
Protein degradation (micromol/min)
Measured: Baseline, end of intervention
Diastolic blood pressure (bpm)
Measured: Daily for a duration of 16 days
Capillary pH
Measured: Baseline, after 3, 6, 8, 10 days of intervention, 2 days after finishing intervention
Capillary HCO3- Concentration (mmol/L)
Measured: Baseline, after 3, 6, 8, 10 days of intervention, 2 days after finishing intervention
Capillary Base excess (mmol/L)
Measured: Baseline, after 3, 6, 8, 10 days of intervention, 2 days after finishing intervention
Capillary pCO2 (mmHg)
Measured: Baseline, after 3, 6, 8, 10 days of intervention, 2 days after finishing intervention
Capillary pO2 (mmHg)
Measured: Baseline, after 3, 6, 8, 10 days of intervention, 2 days after finishing intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2012 (estimated)
- Study startJul 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Grade Metabolic AcidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- DLR German Aerospace Center
- Sponsor type
- University, hospital or other
- Collaborators
- Charite University, Berlin, Germany, University of Erlangen-Nürnberg
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01655953
- Sponsor's protocol ID
- DLR Salty Life 8 Study
- Acronym
- SL8
- Status last verified
- Jul 2012
- First submitted
- 23 Jul 2012
- Last updated
- 2 Aug 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Acid Base Status During High Salt Intake
- ClinicalTrials.gov ID
- NCT01655953
- Acronym / sponsor ID
- SL8 / DLR Salty Life 8 Study
- Conditions
- Low Grade Metabolic Acidosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- DLR German Aerospace CenterUniversity, hospital or other
- Collaborators
- Charite University, Berlin, Germany, University of Erlangen-Nürnberg
- Study start
- Jul 2007
- Study completion
- Aug 2007 (actual)
- First posted
- 2 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Campaign 1 | Experimental | Dietary Supplement: High NaCl + KHCO3, Other: Control: high NaCl |
| Campaign 2 | Experimental | Dietary Supplement: High NaCl + KHCO3, Other: Control: high NaCl |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- healthy males
- 19 - 35 years
- 65 - 85kg
- 170 - 190 cm
- successfully completed psychological and medical screening
Key exclusion criteria (12 listed)
- athletes
- smoking
- drug- or alcohol abuse
- hyperlipidemia
- renal diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High NaCl + KHCO37.7 mmol Na/kgBW/d + 90 mmol KHCO3 | Dietary supplement | Campaign 1, Campaign 2 |
| Control: high NaCl7.7 mmol Na/kgBW/d | Other | Campaign 1, Campaign 2 |
Primary outcome
Change in daily urinary C- and N-terminal bone collagen telopeptides (mmol/d)
Time frame: Daily for a duration of 16 days
16 secondary outcomes
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
Daily Nitrogen balance (g/d)
Time frame: 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
Phenylalanine hydroxylation (micromol/min)
Time frame: Baseline, end of intervention
Systolic blood pressure (bpm)
Time frame: Daily for a duration of 16 days
24h urinary net acid excretion (mEq/d)
Time frame: 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
Free cortisone excretion in 24h urine (microg/d)
Time frame: Baseline, after 3, 6, 10 days of intervention
Protein synthesis (micromol/min)
Time frame: Baseline, end of intervention
Protein degradation (micromol/min)
Time frame: Baseline, end of intervention
Diastolic blood pressure (bpm)
Time frame: 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
Capillary HCO3- Concentration (mmol/L)
Time frame: 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
Capillary pCO2 (mmHg)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High NaCl + KHCO3 in people with Low Grade Metabolic Acidosis, run by DLR German Aerospace Center at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in daily urinary C- and N-terminal bone collagen telopeptides (mmol/d) (time frame: Daily for a duration of 16 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2012.