NCT05881018

Brief Summary

A randomized, counterbalanced intervention study in esport players.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 30, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

September 19, 2024

Status Verified

May 1, 2023

Enrollment Period

5 months

First QC Date

April 12, 2023

Last Update Submit

September 6, 2024

Conditions

Sports Physical TherapyDietary HabitsDiet, Healthy

Outcome Measures

Primary Outcomes (1)

  • Change in esport performance (test battery)

    Reaction time will be measured using an esport test battery

    4 weeks

Secondary Outcomes (2)

  • Glucose response (continuous glucose monitor): 3h iAUC

    4 weeks

  • Glycaemic variability (continuous glucose monitor): 24h MAGE

    4 weeks

Study Arms (4)

Low glycaemic index

EXPERIMENTAL
Dietary Supplement: Low glycaemic index

Low glycaemic index with physical activity units

EXPERIMENTAL
Dietary Supplement: Low glycaemic indexBehavioral: Physical activity

High glycaemic index

EXPERIMENTAL
Dietary Supplement: High glycaemic index

High glycaemic index with physical activity units

EXPERIMENTAL
Dietary Supplement: High glycaemic indexBehavioral: Physical activity

Interventions

Low glycaemic indexDIETARY_SUPPLEMENT

Diet will be supplemented with a drink containing a low glycaemic index carbohydrate

Low glycaemic indexLow glycaemic index with physical activity units
High glycaemic indexDIETARY_SUPPLEMENT

Diet will be supplemented with a drink containing a high glycaemic index carbohydrate

High glycaemic indexHigh glycaemic index with physical activity units
Physical activityBEHAVIORAL

Participants will include physical activity units

High glycaemic index with physical activity unitsLow glycaemic index with physical activity units

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Informed consent obtained
  • Male or female aged 18-45 years
  • Healthy
  • Participants have to be part of an esport association and/or regularly participate in tournaments

You may not qualify if:

  • diabetes mellitus type 1 or 2 (T1DM or T2DM)
  • medication which impacts glucose metabolism or visual perception
  • health issues like cardiovascular diseases, severe orthopaedic conditions or neurological impairments
  • food allergies or intolerances, e.g. fructose malabsorption

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

German Sports University Cologne

Cologne, Germany

Location

MeSH Terms

Conditions

Feeding Behavior

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2023

First Posted

May 30, 2023

Study Start

July 1, 2023

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

September 19, 2024

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)