- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06165393
The Effect of Alginate Encapsulated Supplements on Athletic Performance and Recovery (SWAP)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Per B Jeppesen, PhD
- Phone Number: +4528151877
- Email: per.bendix.jeppesen@clin.au.dk
Study Contact Backup
- Name: Lotte L Nielsen, M.Sc.
- Phone Number: +4522995827
- Email: lln@clin.au.dk
Study Locations
-
-
-
Aarhus N, Denmark, 8200
- Recruiting
- Per Bendix Jeppesen
-
Contact:
- Per B Jeppesen, Ph.d
- Phone Number: 28151877
- Email: per.bendix.jeppesen@clin.au.dk
-
Contact:
- Lotte L Nielsen
- Phone Number: +45 22995827
- Email: lln@clin.au.dk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Slow-release CHO-AA
Alginate encapsulated Carbohydrates and Amino Acids
|
Slow-release CHO-AA, alginate encapsulated
|
|
Experimental: Slow-release CHO
Alginate encapsulated Carbohydrates
|
Slow-release CHO, alginate encapsulated
|
|
Active Comparator: CHO
Carbohydrates only
|
Carbohydrate-only, control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Performance
Time Frame: approx. 90 min-120 min
|
Time-To-Exhaustion performance test
|
approx. 90 min-120 min
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SWAP AU
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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