NCT06165393

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

May 11, 2022

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 11, 2023

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

December 11, 2023

Status Verified

December 1, 2023

Enrollment Period

1.6 years

First QC Date

December 1, 2023

Last Update Submit

December 1, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Performance

    Time-To-Exhaustion performance test

    approx. 90 min-120 min

Study Arms (3)

Slow-release CHO-AA

EXPERIMENTAL

Alginate encapsulated Carbohydrates and Amino Acids

Dietary Supplement: Slow-release CHO-AA

Slow-release CHO

EXPERIMENTAL

Alginate encapsulated Carbohydrates

Dietary Supplement: Slow-release CHO

CHO

ACTIVE COMPARATOR

Carbohydrates only

Dietary Supplement: CHO

Interventions

Slow-release CHO-AADIETARY_SUPPLEMENT

Slow-release CHO-AA, alginate encapsulated

Slow-release CHO-AA
Slow-release CHODIETARY_SUPPLEMENT

Slow-release CHO, alginate encapsulated

Slow-release CHO
CHODIETARY_SUPPLEMENT

Carbohydrate-only, control

CHO

Eligibility Criteria

Age18 Years - 50 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Per Bendix Jeppesen

Aarhus N, 8200, Denmark

RECRUITING

Central Study Contacts

Lotte L Nielsen, M.Sc.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate. Prof, PhD.

Study Record Dates

First Submitted

December 1, 2023

First Posted

December 11, 2023

Study Start

May 11, 2022

Primary Completion

December 1, 2023

Study Completion

December 31, 2023

Last Updated

December 11, 2023

Record last verified: 2023-12

Locations