Steviol Glycoside for Use in Restoring Muscle Glycogen by Increasing the Rate of Glycogen Re-synthesis in Muscles
steviagly
Compositions Comprising a Steviol Glycoside for Use in Restoring Muscle Glycogen by Increasing the Rate of Glycogen Re-synthesis in Muscles
1 other identifier
interventional
22
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2013
Typical duration for not_applicable
1 active site
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
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 21, 2014
CompletedFirst Posted
Study publicly available on registry
May 23, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedMay 23, 2014
May 1, 2014
1.4 years
May 21, 2014
May 22, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effects on glycogen re-synthesis
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.
2 weeks
Study Arms (2)
placebo / Corn starch
PLACEBO COMPARATORCarbohydrate-containing composition that comprises 2 g carbohydrate per kg of body weight. This composition will be 500 mg placebo starch corn.
Carbohydrate steviol glycosides
ACTIVE COMPARATOR500 mg steviol glycosides.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Healthy and well trained, sporty exhaustive trained males, age 18 to 40 years old.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Per Bendix Jeppesenlead
- University of Aarhuscollaborator
- Aarhus University Hospitalcollaborator
Study Sites (1)
Aarhus University Hospital, Dept of Clinical medicine
Aarhus C, 8000, Denmark
Study Officials
- PRINCIPAL INVESTIGATOR
Per B Jeppesen, Prof., PhD
Aarhus University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Prof, PhD
Study Record Dates
First Submitted
May 21, 2014
First Posted
May 23, 2014
Study Start
September 1, 2013
Primary Completion
February 1, 2015
Study Completion
July 1, 2015
Last Updated
May 23, 2014
Record last verified: 2014-05