Acid-Base Balance, Metabolism and Minerals (BASICA)

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

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Acidosis; Acid-Base Balance Disorder
• Intervention / Treatment: Dietary supplement: alkaline salt mixture; Dietary supplement: placebo

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Basica; 4-week dietary supplementation with an alkaline salt (Basica)	Dietary supplement: alkaline salt mixture; blood and tissue alkalinisation; Other Names: Basica
PLACEBO_COMPARATOR: Placebo; 4-week dietary supplementation with a placebo	Dietary supplement: placebo; no blood and tissue alkalinisation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in muscle dialysate lactate-pyruvate ratio	surrogate measure for muscle tissue pH	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

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 3, 2013
• Primary Completion (ACTUAL): December 30, 2014
• Study Completion (ACTUAL): December 30, 2015

Study Registration Dates

• First Submitted: January 7, 2020
• First Submitted That Met QC Criteria: January 13, 2020
• First Posted (ACTUAL): January 14, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 22, 2020
• Last Update Submitted That Met QC Criteria: January 21, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: microdialysis; energy metabolism; calorimetry; randomized placebo-controlled trial; acid-base balance; protein-rich diet; alkaline supplementation
• Additional Relevant MeSH Terms: Metabolic Diseases; Acid-Base Imbalance; Acidosis
• Other Study ID Numbers: BASICA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No