NCT05207332

Brief Summary

The feeding strategies during recovery are essential to optimize a subsequent performance. Carbohydrate is a major fuel source during exercise as it has been shown to maintain high rates of carbohydrate oxidation. Protein intake in combination with carbohydrate have been shown to increase Amino acid bioavailability and may alter physiologic responses during exercise, which may be relevant to endurance performance. The goal of this study is to assess the effect of a new developed vegan product on athletes recovery and subsequent performance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration 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

Study Start

First participant enrolled

March 6, 2019

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 26, 2022

Completed
Last Updated

January 26, 2022

Status Verified

January 1, 2022

Enrollment Period

2.9 years

First QC Date

March 14, 2019

Last Update Submit

January 25, 2022

Conditions

Athletic Performance

Outcome Measures

Primary Outcomes (1)

  • Performance

    Time-to-exhaustion. Measured by the duration of high intensity exercise performed to exhaustion.

    Aprox. 120 minutes

Study Arms (2)

Vegan product

EXPERIMENTAL
Dietary Supplement: CHO+PRO

Control

ACTIVE COMPARATOR
Dietary Supplement: CHO

Interventions

CHO+PRODIETARY_SUPPLEMENT

A vegan product containing carbohydrate and protein

Vegan product
CHODIETARY_SUPPLEMENT

containing carbohydrate

Control

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
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

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 glykogen synthesis and/or performance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University

Aarhus, 8000, Denmark

Location

MeSH Terms

Interventions

CVS 1123

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate professor, Ph.D.

Study Record Dates

First Submitted

March 14, 2019

First Posted

January 26, 2022

Study Start

March 6, 2019

Primary Completion

January 25, 2022

Study Completion

January 25, 2022

Last Updated

January 26, 2022

Record last verified: 2022-01

Locations

DK(1)