Sports Physical TherapyNCT05881018
Investigating the Effects of Diet and Physical Activity on Esport Performance
A study testing Low glycaemic index, High glycaemic index and Physical activity in people with Sports Physical Therapy and Dietary Habits, run by Beneo-Institute at 1 site in Germany.
Trial summary
A randomized, counterbalanced intervention study in esport players. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Sports Physical Therapy, Dietary Habits, Diet, Healthy
- What is being tested?
- Low glycaemic index, High glycaemic index and Physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2023to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
A randomized, counterbalanced intervention study in esport players.
Read the detailed description
The study will test whether i) the consumption of two different carbohydrate drinks and ii) the performance of regular high-intensity interval training will impact esport performance and metabolic profile.
- Conditions
- Sports Physical Therapy, Dietary Habits, Diet, Healthy
- Being tested
- Low glycaemic index, High glycaemic index, Physical activity
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low glycaemic indexDietary supplement
Diet will be supplemented with a drink containing a low glycaemic index carbohydrate
High glycaemic indexDietary supplement
Diet will be supplemented with a drink containing a high glycaemic index carbohydrate
Physical activityBehavioural
Participants will include physical activity units
| Study group | Role | What they receive |
|---|---|---|
| Low glycaemic index | Experimental | Not described Receives: Dietary Supplement: Low glycaemic index |
| Low glycaemic index with physical activity units | Experimental | Not described Receives: Dietary Supplement: Low glycaemic index; Behavioral: Physical activity |
| High glycaemic index | Experimental | Not described Receives: Dietary Supplement: High glycaemic index |
| High glycaemic index with physical activity units | Experimental | Not described Receives: Dietary Supplement: High glycaemic index; Behavioral: Physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in esport performance (test battery)
Reaction time will be measured using an esport test battery
Measured: 4 weeks
Secondary outcomes (2)
Glucose response (continuous glucose monitor): 3h iAUC
The 3h incremental area under the curve (iAUC) will be used to assess glycemic response to the drink. Unit: mg/dL
Measured: 4 weeks
Glycaemic variability (continuous glucose monitor): 24h MAGE
The mean amplitude of glycemic excursion during 24h will be assessed as an indicator for glycemic variability. Unit: mg/dL
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start1 Jul 2023
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sports Physical TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beneo-Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- German Sport University, Cologne
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05881018
- Sponsor's protocol ID
- ES01
- Status last verified
- May 2023
- First submitted
- 12 Apr 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Diet and Physical Activity on Esport Performance
- ClinicalTrials.gov ID
- NCT05881018
- Acronym / sponsor ID
- ES01
- Conditions
- Sports Physical Therapy, Dietary Habits, Diet, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Beneo-InstituteIndustry (pharma, biotech, devices)
- Collaborators
- German Sport University, Cologne
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 30 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized, counterbalanced intervention study in esport players.
Detailed description
The study will test whether i) the consumption of two different carbohydrate drinks and ii) the performance of regular high-intensity interval training will impact esport performance and metabolic profile.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low glycaemic index | Experimental | Dietary Supplement: Low glycaemic index |
| Low glycaemic index with physical activity units | Experimental | Dietary Supplement: Low glycaemic index, Behavioral: Physical activity |
| High glycaemic index | Experimental | Dietary Supplement: High glycaemic index |
| High glycaemic index with physical activity units | Experimental | Dietary Supplement: High glycaemic index, Behavioral: Physical activity |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low glycaemic indexDiet will be supplemented with a drink containing a low glycaemic index carbohydrate | Dietary supplement | Low glycaemic index, Low glycaemic index with physical activity units |
| High glycaemic indexDiet will be supplemented with a drink containing a high glycaemic index carbohydrate | Dietary supplement | High glycaemic index, High glycaemic index with physical activity units |
| Physical activityParticipants will include physical activity units | Behavioural | High glycaemic index with physical activity units, Low glycaemic index with physical activity units |
Primary outcome
Change in esport performance (test battery)
Time frame: 4 weeks
Reaction time will be measured using an esport test battery
2 secondary outcomes
Glucose response (continuous glucose monitor): 3h iAUC
Time frame: 4 weeks
Glycaemic variability (continuous glucose monitor): 24h MAGE
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low glycaemic index, High glycaemic index and Physical activity in people with Sports Physical Therapy and Dietary Habits, run by Beneo-Institute at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in esport performance (test battery) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.