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Steviol Glycoside for Use in Restoring Muscle Glycogen by Increasing the Rate of Glycogen Re-synthesis in Muscles (steviagly)

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ClinicalTrials.gov Identifier: NCT02146183
Recruitment Status : Unknown
Verified May 2014 by Per Bendix Jeppesen, Aarhus University Hospital.
Recruitment status was:  Recruiting
First Posted : May 23, 2014
Last Update Posted : May 23, 2014
Sponsor:
Collaborators:
University of Aarhus
Aarhus University Hospital
Information provided by (Responsible Party):
Per Bendix Jeppesen, Aarhus University Hospital

Brief Summary:
The aim of this experiment is to investigate if intake of stevioside in addition to a carbohydrate-containing composition after work related depletion of muscle glycogen will increase the rate of glycogen re-synthesis as compared with intake of the carbohydrate-containing composition alone.

Condition or disease Intervention/treatment Phase
Glycogen Depletion Dietary Supplement: Carbohydrate steviol glycosides Dietary Supplement: Placebo Corn Starch Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Compositions Comprising a Steviol Glycoside for Use in Restoring Muscle Glycogen by Increasing the Rate of Glycogen Re-synthesis in Muscles
Study Start Date : September 2013
Estimated Primary Completion Date : February 2015
Estimated Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Starch Stevia

Arm Intervention/treatment
Placebo Comparator: placebo / Corn starch
Carbohydrate-containing composition that comprises 2 g carbohydrate per kg of body weight. This composition will be 500 mg placebo starch corn.
Dietary Supplement: Placebo Corn Starch
500 mg/day

Active Comparator: Carbohydrate steviol glycosides
500 mg steviol glycosides.
Dietary Supplement: Carbohydrate steviol glycosides
To investigate if intake of stevioside in addition to a carbohydrate-containing composition after work related depletion of muscle glycogen will increase the rate of glycogen re-synthesis as compared with intake of the carbohydrate-containing composition alone.




Primary Outcome Measures :
  1. Effects on glycogen re-synthesis [ Time Frame: 2 weeks ]

    During the working session the test subjects will be exercising for 2 hours on a bicycle ergometer at 65-75% of VO2-max.

    Immediately after the working session the test subject will be given a carbohydrate-containing composition that comprises 2 g carbohydrate per kg of body weight. Also 2 hours after completion of the working session the test persons will be given a carbohydrate-containing composition that comprises 2 g carbohydrate per kg of body weight. These compositions will be added either 500 mg stevioside or placebo (starch corn).

    After collection of the muscle biopsies the samples will be stored under liquid nitrogen. The parameter evaluated in the muscles biopsies will be glycogen.




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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Inclusion criteria:
  • Healthy and well trained, sporty exhaustive trained males, age 18 to 40 years old.

Exclusion Criteria:

  • Persons suffering of a metabolic disease, which is related to the carbohydrate metabolism, such as diabetes type 1 or 2, insulin resistance and the like, cannot be included in the test. Also persons, who are prescribed a medical drug or diet supplement that could affect the carbohydrate metabolism, will be excluded from the study. Finally persons that are not capable of completing the fasting period or the test design will be excluded from the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02146183


Contacts
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Contact: Per B Jeppesen, prof, PhD -4528151877 per.bendix.jeppesen@ki.au.dk

Locations
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Denmark
Aarhus University Hospital, Dept of Clinical medicine Recruiting
Aarhus C, Denmark, 8000
Contact: Per B Jeppesen, Prof, PhD    +45-28151877    per.bendix.jeppesen@ki.au.dk   
Principal Investigator: Per B Jeppesen, Prof, PhD         
Sub-Investigator: Søren Larvsen, Prof-Sport         
Sponsors and Collaborators
Per Bendix Jeppesen
University of Aarhus
Aarhus University Hospital
Investigators
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Principal Investigator: Per B Jeppesen, Prof., PhD Aarhus University Hospital

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Responsible Party: Per Bendix Jeppesen, Associate Prof, PhD, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT02146183     History of Changes
Other Study ID Numbers: Aarhus University
First Posted: May 23, 2014    Key Record Dates
Last Update Posted: May 23, 2014
Last Verified: May 2014
Keywords provided by Per Bendix Jeppesen, Aarhus University Hospital:
Stevio glycosides
sport
glycogen
Additional relevant MeSH terms:
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Cardiac Glycosides
Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs