NCT01831492

Brief Summary

Purpose: This study investigates the effects of dietary zeolite + dolomite on performance, exercise-induced acidosis, oxidative stress, inflammation and intestinal barrier dysfunction in trained people. Hypotheses (H1): Zeolite + dolomite increase performance in an ergometer step test Zeolite + dolomite reduce exercise-induced acidosis Zeolite + dolomite reduce oxidative stress Zeolite + dolomite reduce inflammation Zeolite + dolomite improve intestinal barrier dysfunction

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 15, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

February 10, 2016

Status Verified

February 1, 2016

Enrollment Period

1.1 years

First QC Date

April 9, 2013

Last Update Submit

February 9, 2016

Conditions

Keywords

performanceacidosisoxidative stressinflammationoxygen uptake

Outcome Measures

Primary Outcomes (1)

  • Change of aerobic performance capability between baseline, 4 and 12 weeks

    Zeolite and Dolomite might influence maximum aerobic performance due to attenuated lactate accumulation in a step test ergometry

    0, 4, 12 weeks

Secondary Outcomes (1)

  • Change of lactate concentrations in blood between baseline, 4 and 12 weeks

    0, 4, 12 weeks

Other Outcomes (1)

  • Change in redox biology between baseline, 4 and 12 weeks

    0, 4, 12 weeks

Study Arms (2)

zeolite + dolomite

ACTIVE COMPARATOR

28 trained subjects receive encapsulated zeolite + dolomite

Device: zeolite + dolomite

cellulose

PLACEBO COMPARATOR

28 trained subjects receive encapsulated micro-crystalline cellulose

Device: cellulose

Interventions

Given for 12 weeks, after a 4 weeks wash- out of all supplements/drugs

Also known as: Panaceo Sport
zeolite + dolomite
celluloseDEVICE

given for 14 weeks

Also known as: placebo
cellulose

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • trained people
  • non-smokers
  • body fat: 20-30%
  • wk wash-out 20-50 years old

You may not qualify if:

  • sedentary people
  • smokers
  • people not eligible for exercise
  • high/low body fat
  • people taking supplements
  • to young/old people

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Green Beat

Graz, 8042, Austria

Location

MeSH Terms

Conditions

AcidosisInflammation

Condition Hierarchy (Ancestors)

Acid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Manfred Lamprecht, Prof

    Green Beat

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pricipal Investigator

Study Record Dates

First Submitted

April 9, 2013

First Posted

April 15, 2013

Study Start

April 1, 2013

Primary Completion

May 1, 2014

Study Completion

December 1, 2014

Last Updated

February 10, 2016

Record last verified: 2016-02

Locations