Acid-Base Balance, Metabolism and Minerals (BASICA)

Charité University Medicine Berlin

Status: Completed

Conditions: Acid-Base Balance Disorder; Metabolic Acidosis

Treatments: Dietary Supplement: alkaline salt mixture; Dietary Supplement: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04229069

BASICA

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 60 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Basica

Active Comparator group

Description:

4-week dietary supplementation with an alkaline salt (Basica)

Treatment:

Dietary Supplement: alkaline salt mixture

Placebo

Placebo Comparator group

Description:

4-week dietary supplementation with a placebo

Treatment:

Dietary Supplement: placebo