NCT02667340

Brief Summary

To assess the efficacy of a hydrothermally modified starch supplement (Superstarch made byGeneration UCAN) vs isoenergetic placebo (glucose) on exercise performance, execution of specific soccer skills, and on cognitive function during and following a simulated soccer game. Secondary: To compare fat oxidation and carbohydrate oxidation (based on RER data) during the game with Generation UCAN vs isoenergetic placebo (glucose).

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

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

First Submitted

Initial submission to the registry

January 19, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 28, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

January 28, 2016

Status Verified

January 1, 2016

Enrollment Period

10 months

First QC Date

January 19, 2016

Last Update Submit

January 25, 2016

Conditions

Keywords

exercisecarbohydrateSuperstarch

Outcome Measures

Primary Outcomes (1)

  • change in exercise performance

    sprint run test (seconds); soccer skills (seconds), cognitive skills (seconds)

    baseline; 60 minutes later (following soccer game)

Secondary Outcomes (2)

  • change in blood glucose concentration

    baseline; 60 minutes later

  • change in blood lactate concentration

    baseline, 60 minutes later

Study Arms (2)

Superstarch

EXPERIMENTAL

Supplementation with Superstarch before a simulated soccer game

Dietary Supplement: Superstarch

Placebo

PLACEBO COMPARATOR

Supplementation with placebo before simulated soccer game.

Other: Placebo

Interventions

SuperstarchDIETARY_SUPPLEMENT

0.7 g Superstarch or placebo per kg body mass in two ingestions (before game \& at halftime)

Also known as: UCan
Superstarch
PlaceboOTHER

0.7 g glucose per kg body mass in two ingestions (before game \& at halftime)

Placebo

Eligibility Criteria

Age15 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • healthy male and female elite soccer players who are involved in regular soccer training
  • aged 15-35 years

You may not qualify if:

  • Smoker
  • taking part in other research
  • have a neurological or psychiatric condition that may cause cognitive dysfunction
  • for women, if they are pregnant or become pregnant during the study
  • Injury limiting exercise ability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Pete W Lemon, PhD

    Western University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pete w Lemon, PhD

CONTACT

Manuel Quinones, B.ASc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD. Weider Research Chair

Study Record Dates

First Submitted

January 19, 2016

First Posted

January 28, 2016

Study Start

February 1, 2016

Primary Completion

December 1, 2016

Study Completion

August 1, 2017

Last Updated

January 28, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share