NCT03749785

Brief Summary

The aim of this study is to investigate the effects of regular sucrose feeds compared to a single large bolus given late in exercise, on muscle glycogen utilisation, exercise capacity and other markers of metabolism during running

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Shorter than P25 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

October 14, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 19, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 21, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2019

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2019

Completed
Last Updated

November 1, 2019

Status Verified

March 1, 2019

Enrollment Period

5 months

First QC Date

November 19, 2018

Last Update Submit

October 31, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Muscle glycogen concentrations

    Muscle glycogen concentration at rest, after 75 minutes of treadmill running and at volitional exhaustion. Measured using the bergstrom needle technique for obtaining muscle biopsy samples

    Estimated to be between 90 and 145 minutes

  • Exercise capacity

    Time to exhaustion at the pre-determined speed to elicit exhaustion after \~90 minutes when ingesting water only

    Estimated to be between 90 and 145 minutes

Secondary Outcomes (9)

  • Ratings of perceived exertion

    Estimated to be between 90 and 145 minutes

  • Ratings of stomach discomfort

    Estimated to be between 90 and 145 minutes

  • Carbohydrate oxidation

    Estimated to be between 90 and 145 minutes

  • Fat oxidation

    Estimated to be between 90 and 145 minutes

  • Plasma glucose concentrations

    Estimated to be between 90 and 145 minutes

  • +4 more secondary outcomes

Study Arms (2)

Regular carbohydrate feeding

ACTIVE COMPARATOR

Ingestion of 75 g sucrose, given in regular doses for the first 75 minutes of exercise during a time to exhaustion run

Other: Regular carbohydrate feeding

Single carbohydrate bolus

ACTIVE COMPARATOR

Ingestion of 75 g sucrose, given in a single bolus after 75 minutes of exercise, during a time to exhaustion run

Other: Single carbohydrate bolus

Interventions

60 ml of water with 5 g sucrose given every 5 minutes 14 times up until 70 minutes followed by 5 g sucrose after 75 minutes in a 250 ml solution

Regular carbohydrate feeding

60 ml of water given every 5 minutes 14 times up until 70 minutes followed by 75 g sucrose after 75 minutes in a 250 ml solution

Single carbohydrate bolus

Eligibility Criteria

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

You may qualify if:

  • Self-identify as a trained runner
  • Regularly participate in running activity (\>2 times a week)
  • Participated in running based training for a minimum of 2 years
  • Be willing to undertake exercise sessions until volitional exhaustion
  • Be willing to have the necessary samples taken during the testing protocols
  • Not a habitual smoker
  • Have the capacity and willingness to provide informed consent (oral and written)
  • Successful completion of the physical activity readiness questionnaire (PAR-Q)

You may not qualify if:

  • Female
  • \<18 or \>50 years old
  • Not regularly participating in running activity (\<3 times a week)
  • Experience contraindications to the administration of the proposed anaesthetic (Lidocaine Hydrochloride)
  • Habitual/previously habitual smoker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department for Health, University of Bath

Bath, BA2 7AY, United Kingdom

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department for Health

Study Record Dates

First Submitted

November 19, 2018

First Posted

November 21, 2018

Study Start

October 14, 2018

Primary Completion

March 20, 2019

Study Completion

April 16, 2019

Last Updated

November 1, 2019

Record last verified: 2019-03

Locations