Acid-Base Balance, Metabolism and Minerals

Overview

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.

Full Title of Study: “Randomized, Double-blind, Placebo-controlled Intervention Study on Effects of Basica┬« on Acid-base Balance, Metabolism and Quality of Life in Elderly Healthy Volunteers.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 30, 2014

Interventions

  • Dietary Supplement: alkaline salt mixture
    • blood and tissue alkalinisation
  • Dietary Supplement: placebo
    • no blood and tissue alkalinisation

Arms, Groups and Cohorts

  • Active Comparator: Basica
    • 4-week dietary supplementation with an alkaline salt (Basica)
  • Placebo Comparator: Placebo
    • 4-week dietary supplementation with a placebo

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 60 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Charite University, Berlin, Germany
  • Provider of Information About this Clinical Study
    • Principal Investigator: Michael Boschmann, Principal Investigator – Charite University, Berlin, Germany

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