Acid-Base Balance, Metabolism and Minerals

NCT04229069 | Completed

• 1 other identifier: BASICA
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acid-Base Balance Disorder; Metabolic Acidosis

Keywords

acid-base balance; energy metabolism; protein-rich diet; alkaline supplementation; calorimetry; microdialysis; randomized placebo-controlled trial

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Basica

ACTIVE COMPARATOR

4-week dietary supplementation with an alkaline salt (Basica)

Dietary Supplement: alkaline salt mixture

Placebo

PLACEBO COMPARATOR

4-week dietary supplementation with a placebo

Dietary Supplement: placebo

Interventions

alkaline salt mixture DIETARY_SUPPLEMENT

blood and tissue alkalinisation

Also known as: Basica

Basica

placebo DIETARY_SUPPLEMENT

no blood and tissue alkalinisation

Placebo

Eligibility Criteria

• Age: 60 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

MeSH Terms

Conditions

Acidosis

Interventions

basica

Condition Hierarchy (Ancestors)

Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: January 14, 2020
• Study Start: January 3, 2013
• Primary Completion: December 30, 2014
• Study Completion: December 30, 2015
• Last Updated: January 22, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share