Athletic PerformanceSWAPNCT06165393
The Effect of Alginate Encapsulated Supplements on Athletic Performance and Recovery
A study testing Slow-release CHO-AA, Slow-release CHO and CHO in people with Athletic Performance, run by University of Aarhus at 1 site in Denmark.
Trial summary
Endurance sport is often characterized by high training loads and significant metabolic demands, including depletion of endogenous fuel stores (e.g. liver and muscle glycogen) and damage to the skeletal muscle proteins. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Athletic Performance
- What is being tested?
- Slow-release CHO-AA, Slow-release CHO and CHO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 11 May 2022to 31 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- males between 18-50 years of age
- moderate to trained individuals with a VO2max > 50 ml/min/kg
- accustumed to exercising on a bike
- healthy volunteers
Who cannot join
- persons diagnosed with metabolic diseases (i.e. Type 2 Diabetes) which relates to the carbohydrate metabolism.
- persons ingesting prescribed drugs/medicin, supplements or a special diet (i.e. low carbohydrate), which might affect the glycogen synthesis and/or performance.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Per Bendix Jeppesen
Aarhus N, 8200
Per B Jeppesen, Ph.d, 28151877, per.bendix.jeppesen@clin.au.dk
Lotte L Nielsen, +45 22995827, lln@clin.au.dk
About this study
Endurance sport is often characterized by high training loads and significant metabolic demands, including depletion of endogenous fuel stores (e.g. liver and muscle glycogen) and damage to the skeletal muscle proteins. Nutritional interventions that enhance the restoration of endogenous fuel stores and improve muscle damage repair have received a lot of attention. The primary aim of this project is to clinically test the effect of alginate encapsulation technology on performance. Furthermore, we will investigate the substrate utilization profile during exercise and subsequent recovery.
The encapsulation technology presents a nutrient delivery solution, which results in a sustained or slow-release of the nutrients encapsulated. Thus, potentially optimizing the digestion and absorption by promoting an easy ingestion of high concentrations of fx carbohydrates without negatively affecting the gastrointestinal comfort.
- Conditions
- Athletic Performance
- Being tested
- Slow-release CHO-AA, Slow-release CHO, CHO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slow-release CHO-AADietary supplement
Slow-release CHO-AA, alginate encapsulated
Slow-release CHODietary supplement
Slow-release CHO, alginate encapsulated
CHODietary supplement
Carbohydrate-only, control
| Study group | Role | What they receive |
|---|---|---|
| Slow-release CHO-AA | Experimental | Alginate encapsulated Carbohydrates and Amino Acids Receives: Dietary Supplement: Slow-release CHO-AA |
| Slow-release CHO | Experimental | Alginate encapsulated Carbohydrates Receives: Dietary Supplement: Slow-release CHO |
| CHO | Active comparator | Carbohydrates only Receives: Dietary Supplement: CHO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance
Time-To-Exhaustion performance test
Measured: approx. 90 min-120 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start11 May 2022
- Primary completion1 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Athletic PerformanceStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Innovation Fund Denmark
- Responsible party
- Principal investigator, Per Bendix Jeppesen, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06165393
- Sponsor's protocol ID
- SWAP AU
- Acronym
- SWAP
- Status last verified
- Dec 2023
- First submitted
- 1 Dec 2023
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Alginate Encapsulated Supplements on Athletic Performance and Recovery
- ClinicalTrials.gov ID
- NCT06165393
- Acronym / sponsor ID
- SWAP / SWAP AU
- Conditions
- Athletic Performance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Innovation Fund Denmark
- Study start
- 11 May 2022 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 11 Dec 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.
Endurance sport is often characterized by high training loads and significant metabolic demands, including depletion of endogenous fuel stores (e.g. liver and muscle glycogen) and damage to the skeletal muscle proteins. Nutritional interventions that enhance the restoration of endogenous fuel stores and improve muscle damage repair have received a lot of attention. The primary aim of this project is to clinically test the effect of alginate encapsulation technology on performance. Furthermore, we will investigate the substrate utilization profile during exercise and subsequent recovery.
The encapsulation technology presents a nutrient delivery solution, which results in a sustained or slow-release of the nutrients encapsulated. Thus, potentially optimizing the digestion and absorption by promoting an easy ingestion of high concentrations of fx carbohydrates without negatively affecting the gastrointestinal comfort.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Slow-release CHO-AA | Experimental | Dietary Supplement: Slow-release CHO-AAAlginate encapsulated Carbohydrates and Amino Acids |
| Slow-release CHO | Experimental | Dietary Supplement: Slow-release CHOAlginate encapsulated Carbohydrates |
| CHO | Active comparator | Dietary Supplement: CHOCarbohydrates only |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- males between 18-50 years of age
- moderate to trained individuals with a VO2max > 50 ml/min/kg
- accustumed to exercising on a bike
- healthy volunteers
Key exclusion criteria (2 listed)
- persons diagnosed with metabolic diseases (i.e. Type 2 Diabetes) which relates to the carbohydrate metabolism.
- persons ingesting prescribed drugs/medicin, supplements or a special diet (i.e. low carbohydrate), which might affect the glycogen synthesis and/or performance.
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 |
|---|---|---|
| Slow-release CHO-AASlow-release CHO-AA, alginate encapsulated | Dietary supplement | Slow-release CHO-AA |
| Slow-release CHOSlow-release CHO, alginate encapsulated | Dietary supplement | Slow-release CHO |
| CHOCarbohydrate-only, control | Dietary supplement | CHO |
Primary outcome
Performance
Time frame: approx. 90 min-120 min
Time-To-Exhaustion performance test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
Related trials for Athletic Performance
Recruiting
Acute Effects of Post-Exercise Hyperoxia on Recovery in Cycling
Athletic Performance, Hyperbaric Oxygenation
Not yet recruiting
Core Strength Training, Anthropometry, and Postural Control in Youth Optimist Sailors
Postural Control, Athletic Performance
Recruiting
Effects of Scapular Training on Adolescent Boxers
Sports Physical Therapy
Active, not recruiting
Effects of Blood Flow Restriction Training on Physical Function, Muscle Adaptations, and Performance in Roller Skaters
Athletic Performance Enhancement
Recruiting
UCLA Magnesium Formulation Athlete Study
Athletic Performance, Recovery
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Slow-release CHO-AA, Slow-release CHO and CHO in people with Athletic Performance, run by University of Aarhus at 1 site in Denmark.
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 2 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: status not confirmed, as of the sponsor's last update on 11 Dec 2023. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Per B Jeppesen, PhD (+4528151877, per.bendix.jeppesen@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance (time frame: approx. 90 min-120 min). 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 11 Dec 2023.