NCT03903861

Brief Summary

This study will compare short-term post-exercise muscle glycogen synthesis following combined galactose-glucose, glucose alone or galactose alone ingestion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2019

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

First Submitted

Initial submission to the registry

March 29, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 4, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

January 4, 2023

Status Verified

December 1, 2022

Enrollment Period

10 months

First QC Date

March 29, 2019

Last Update Submit

January 3, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Muscle glycogen synthesis rates (mmol/kg/dm/h)

    Muscle glycogen synthesis rates over the post-exercise recovery period

    4 hours

Secondary Outcomes (9)

  • Carbohydrate oxidation rates (g/min)

    Up to 90 minutes

  • Fat oxidation rates (g/min)

    Up to 90 minutes

  • Plasma glucose (mmol/L)

    Up to 6 hours

  • Serum insulin (mU/L)

    Up to 6 hours

  • Plasma galactose (mmol/L)

    Up to 6 hours

  • +4 more secondary outcomes

Study Arms (3)

Glucose alone

EXPERIMENTAL

Participants will complete a glycogen depleting bout of exercise followed by the provision of glucose-alone over 4 hours of recovery before a subsequent bout of exercise.

Other: Glucose alone

Galactose alone

EXPERIMENTAL

Participants will complete a glycogen depleting bout of exercise followed by the provision of galactose-alone over 4 hours of recovery before a subsequent bout of exercise.

Other: Galactose alone

Glucose and galactose

EXPERIMENTAL

Participants will complete a glycogen depleting bout of exercise followed by the provision of glucose and galactose over 4 hours of recovery before a subsequent bout of exercise.

Other: Glucose and galactose

Interventions

Young men or women will complete a glycogen depleting bout of exercise followed by the provision of glucose-alone over 4 hours of recovery before a subsequent bout of exercise.

Glucose alone

Young men or women will complete a glycogen depleting bout of exercise followed by the provision of galactose-alone over 4 hours of recovery before a subsequent bout of exercise.

Galactose alone

Young men or women will complete a glycogen depleting bout of exercise followed by the provision of glucose and galactose over 4 hours of recovery before a subsequent bout of exercise.

Glucose and galactose

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index in the range: 18.5 - 27.5 kg/m2
  • Participates in endurance-based exercise (e.g. cycling, running, rowing) at least 3 times per week
  • Aerobic fitness: VO2max \>45 ml/kg/min (men), \>40 ml/kg/min (women)

You may not qualify if:

  • Lidocaine allergy
  • Current participation in another scientific/clinical study
  • Bleeding disorder/s
  • Current or recent smoker to include vaping (last 60 days)
  • Vegan
  • Existence of food intolerances
  • Poor recent health as indicated in the general health questionnaire
  • Engage in uncommon eating practices (e.g. sustained periods of fasting)
  • Diagnosed with galactosemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Sport, Exercise and Rehabilitation Sciences

Birmingham, West Midlands, B15 2TT, United Kingdom

Location

MeSH Terms

Conditions

Motor Activity

Interventions

GlucoseGalactose

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • Gareth Wallis, PhD

    University of Birmingham

    PRINCIPAL INVESTIGATOR

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
SPONSOR

Study Record Dates

First Submitted

March 29, 2019

First Posted

April 4, 2019

Study Start

July 1, 2019

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

January 4, 2023

Record last verified: 2022-12

Locations