Acid-Base Balance DisorderBASICANCT04229069
Acid-Base Balance, Metabolism and Minerals
A study testing alkaline salt mixture in people with Acid-Base Balance Disorder and Metabolic Acidosis, run by Charite University, Berlin, Germany.
Trial summary
Metabolism is controlled by macro- and micronutrients. Protein-rich diets should lead to latent acidosis at tissue level with further negative implications. Food supplements with alkaline salts are available and popular pretending to prevent these changes. Read more about this study
- Who is it for?
- Ages 60 to 70 years
- Conditions the study is for
- Acid-Base Balance Disorder, Metabolic Acidosis
- What is being tested?
- alkaline salt mixture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 3 Jan 2013to 30 Dec 2015
- 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 60 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- slightly reduced kidney function (GFR 60-89 ml/min)
- Body mass index 20.0 - 29.9 kg/m2
- normal daily diet composition: 45-50, 35-40, and 15 E% from carbs, fats and proteins, respectively
Who cannot join
- sorbitol-/fructose-intolerance
- intake of antacidic drugs
- vegetarians, vegans
- intake of any nutritional supplements
- any cardiovascular, pulmonary, endocrine or metabolic diseases
- any drug abuse
- intake of any anticoagulant drugs
About this study
Official title: Randomized, Double-blind, Placebo-controlled Intervention Study on Effects of Basica® on Acid-base Balance, Metabolism and Quality of Life in Elderly Healthy Volunteers.
Metabolism is controlled by macro- and micronutrients. Protein-rich diets should lead to latent acidosis at tissue level with further negative implications. Food supplements with alkaline salts are available and popular pretending to prevent these changes.
Within a randomized double-blind placebo-controlled trial, the investigators tested the hypotheses 1) that a 4-week protein-rich diet induces a latent tissue acidosis and 2) an alkaline supplement can compensate this. Acid-base balance and important metabolic parameters were determined before and after 4 weeks of supplementation by peripheral blood samples, indirect calorimetry and muscle microdialysis before and after a protein-rich test meal.
- Conditions
- Acid-Base Balance Disorder, Metabolic Acidosis
- Being tested
- alkaline salt mixture, placebo
- Keywords
- acid-base balance, energy metabolism, protein-rich diet, alkaline supplementation, calorimetry, microdialysis, randomized placebo-controlled trial
- Medical subject headings
- Acidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alkaline salt mixtureDietary supplement
Also called Basica
blood and tissue alkalinisation
placeboDietary supplement
no blood and tissue alkalinisation
| Study group | Role | What they receive |
|---|---|---|
| Basica | Active comparator | 4-week dietary supplementation with an alkaline salt (Basica) Receives: Dietary Supplement: alkaline salt mixture |
| Placebo | Placebo comparator | 4-week dietary supplementation with a placebo Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in muscle dialysate lactate-pyruvate ratio
surrogate measure for muscle tissue pH
Measured: before and after 4-weeks of supplementation at baseline (after a 12 hours overnight fast) and 60, 120, and 180 minutes after a protein-enriched test meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start3 Jan 2013
- Primary completion30 Dec 2014
- Study completion30 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acid-Base Balance DisorderStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Boschmann, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04229069
- Sponsor's protocol ID
- BASICA
- Acronym
- BASICA
- Status last verified
- Jan 2020
- First submitted
- 7 Jan 2020
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Intervention Study on Effects of Basica® on Acid-base Balance, Metabolism and Quality of Life in Elderly Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT04229069
- Acronym / sponsor ID
- BASICA / BASICA
- Conditions
- Acid-Base Balance Disorder, Metabolic Acidosis
- Keywords
- acid-base balance, energy metabolism, protein-rich diet, alkaline supplementation, calorimetry, microdialysis, randomized placebo-controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 3 Jan 2013 (actual)
- Primary completion
- 30 Dec 2014 (actual)
- Study completion
- 30 Dec 2015 (actual)
- First posted
- 14 Jan 2020 (actual)
- 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.
Metabolism is controlled by macro- and micronutrients. Protein-rich diets should lead to latent acidosis at tissue level with further negative implications. Food supplements with alkaline salts are available and popular pretending to prevent these changes.
Within a randomized double-blind placebo-controlled trial, the investigators tested the hypotheses 1) that a 4-week protein-rich diet induces a latent tissue acidosis and 2) an alkaline supplement can compensate this. Acid-base balance and important metabolic parameters were determined before and after 4 weeks of supplementation by peripheral blood samples, indirect calorimetry and muscle microdialysis before and after a protein-rich test meal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Basica | Active comparator | Dietary Supplement: alkaline salt mixture4-week dietary supplementation with an alkaline salt (Basica) |
| Placebo | Placebo comparator | Dietary Supplement: placebo4-week dietary supplementation with a placebo |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- slightly reduced kidney function (GFR 60-89 ml/min)
- Body mass index 20.0 - 29.9 kg/m2
- normal daily diet composition: 45-50, 35-40, and 15 E% from carbs, fats and proteins, respectively
Key exclusion criteria (7 listed)
- sorbitol-/fructose-intolerance
- intake of antacidic drugs
- vegetarians, vegans
- intake of any nutritional supplements
- any cardiovascular, pulmonary, endocrine or metabolic 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 |
|---|---|---|
| alkaline salt mixtureAlso: Basicablood and tissue alkalinisation | Dietary supplement | Basica |
| placebono blood and tissue alkalinisation | Dietary supplement | Placebo |
Primary outcome
Change in muscle dialysate lactate-pyruvate ratio
Time frame: before and after 4-weeks of supplementation at baseline (after a 12 hours overnight fast) and 60, 120, and 180 minutes after a protein-enriched test meal
surrogate measure for muscle tissue pH
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 22 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing alkaline salt mixture in people with Acid-Base Balance Disorder and Metabolic Acidosis, run by Charite University, Berlin, 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 3 inclusion and 7 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 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 muscle dialysate lactate-pyruvate ratio (time frame: before and after 4-weeks of supplementation at baseline (after a 12 hours overnight fast) and 60, 120, and 180 minutes after a protein-enriched test meal). 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 22 Jan 2020.