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Acid-Base Balance, Metabolism and Minerals (BASICA)

Primary Purpose

Acid-Base Balance Disorder, Metabolic Acidosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
alkaline salt mixture
placebo
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acid-Base Balance Disorder focused on measuring acid-base balance, energy metabolism, protein-rich diet, alkaline supplementation, calorimetry, microdialysis, randomized placebo-controlled trial

Eligibility Criteria

60 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Basica

    Placebo

    Arm Description

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

    4-week dietary supplementation with a placebo

    Outcomes

    Primary Outcome Measures

    Change in muscle dialysate lactate-pyruvate ratio
    surrogate measure for muscle tissue pH

    Secondary Outcome Measures

    Full Information

    First Posted
    January 7, 2020
    Last Updated
    January 21, 2020
    Sponsor
    Charite University, Berlin, Germany
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04229069
    Brief Title
    Acid-Base Balance, Metabolism and Minerals
    Acronym
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 3, 2013 (Actual)
    Primary Completion Date
    December 30, 2014 (Actual)
    Study Completion Date
    December 30, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Charite University, Berlin, Germany

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acid-Base Balance Disorder, Metabolic Acidosis
    Keywords
    acid-base balance, energy metabolism, protein-rich diet, alkaline supplementation, calorimetry, microdialysis, randomized placebo-controlled trial

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Basica
    Arm Type
    Active Comparator
    Arm Description
    4-week dietary supplementation with an alkaline salt (Basica)
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    4-week dietary supplementation with a placebo
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    alkaline salt mixture
    Other Intervention Name(s)
    Basica
    Intervention Description
    blood and tissue alkalinisation
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    placebo
    Intervention Description
    no blood and tissue alkalinisation
    Primary Outcome Measure Information:
    Title
    Change in muscle dialysate lactate-pyruvate ratio
    Description
    surrogate measure for muscle tissue pH
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Acid-Base Balance, Metabolism and Minerals

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