Acid-Base Balance, Metabolism and Minerals

Metabolic Acidosis Clinical Trial

— BASICA  

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04229069
• Other study ID #: BASICA
• Status: Completed
• Phase: N/A
• Start date: January 3, 2013
• Est. completion date: December 30, 2015

Study information

• Verified date: January 2020
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 30, 2015
• Est. primary completion date: December 30, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Acid-Base Balance Disorder
• Acidosis
• Metabolic Acidosis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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