Acid-Base Balance, Metabolism and Minerals

NCT ID: NCT04229069

Last Updated: 2020-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-03

Study Completion Date

2015-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Acid-Base Balance Disorder Metabolic Acidosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Basica

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

Group Type ACTIVE_COMPARATOR

alkaline salt mixture

Intervention Type DIETARY_SUPPLEMENT

blood and tissue alkalinisation

Placebo

4-week dietary supplementation with a placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

no blood and tissue alkalinisation

Interventions

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alkaline salt mixture

blood and tissue alkalinisation

Intervention Type DIETARY_SUPPLEMENT

placebo

no blood and tissue alkalinisation

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Basica

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Michael Boschmann

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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BASICA

Identifier Type: -

Identifier Source: org_study_id

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