NCT02146183

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

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

May 23, 2014

Status Verified

May 1, 2014

Enrollment Period

1.4 years

First QC Date

May 21, 2014

Last Update Submit

May 22, 2014

Conditions

Keywords

Stevio glycosidessportglycogen

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 COMPARATOR

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

Carbohydrate steviol glycosides

ACTIVE COMPARATOR

500 mg steviol glycosides.

Dietary Supplement: Carbohydrate 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.

Carbohydrate steviol glycosides
Placebo Corn StarchDIETARY_SUPPLEMENT

500 mg/day

placebo / Corn starch

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Study Sites (1)

Aarhus University Hospital, Dept of Clinical medicine

Aarhus C, 8000, Denmark

RECRUITING

Study Officials

  • Per B Jeppesen, Prof., PhD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Per B Jeppesen, prof, PhD

CONTACT

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

Locations