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Acid-Base Balance, Metabolism and Minerals

Randomized, Double-blind, Placebo-controlled Intervention Study on Effects of Basica® on Acid-base Balance, Metabolism and Quality of Life in Elderly Healthy Volunteers.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04229069
Acronym
BASICA
Enrollment
40
Registered
2020-01-14
Start date
2013-01-03
Completion date
2015-12-30
Last updated
2020-01-22

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

Conditions

Acid-Base Balance Disorder, Metabolic Acidosis

Keywords

acid-base balance, energy metabolism, protein-rich diet, alkaline supplementation, calorimetry, microdialysis, randomized placebo-controlled trial

Brief 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. 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.

Interventions

DIETARY_SUPPLEMENTalkaline salt mixture

blood and tissue alkalinisation

DIETARY_SUPPLEMENTplacebo

no blood and tissue alkalinisation

Sponsors

Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change in muscle dialysate lactate-pyruvate ratiobefore 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 mealsurrogate measure for muscle tissue pH

Outcome results

None listed

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