Acid-Base Balance, Metabolism and Minerals

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.

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Key information

Conditions

Acid-Base Balance Disorder Acid-Base Imbalance Acidosis Metabolic Acidosis Metabolic Diseases Nutritional and Metabolic Diseases

Age range

60 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

alkaline salt mixture

Dietary Supplement

blood and tissue alkalinisation

Other names: Basica

Placebo

Dietary Supplement

no blood and tissue alkalinisation

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study 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.

Acronym: BASICA

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2015
First posted: Jan 14, 2020
Registry last updated: Jan 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed