Acid-Base Balance, Metabolism and Minerals

Not Applicable

Completed

• Conditions: Metabolic Acidosis; Acid-Base Balance Disorder
• Interventions: Dietary Supplement: placebo; Dietary Supplement: alkaline salt mixture

• Registration Number: NCT04229069
• Lead Sponsor: Charite University, Berlin, Germany

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-03
• Primary Completion: 2014-12-30
• Study Completion: 2015-12-30
• Status Verified: 2020-01
• Study First Submitted: 2020-01-07
• Study First Submitted QC: 2020-01-13
• Study First Posted: 2020-01-14
• Last Update Submitted: 2020-01-21
• Last Update Posted: 2020-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	4-week dietary supplementation with a placebo
Basica	alkaline salt mixture	4-week dietary supplementation with an alkaline salt (Basica)

Primary Outcome Measures

Name	Time	Method
Change in muscle dialysate lactate-pyruvate ratio	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