Galactose Mediated Glycogen Resynthesis
1 other identifier
interventional
9
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 29, 2019
CompletedFirst Posted
Study publicly available on registry
April 4, 2019
CompletedStudy Start
First participant enrolled
July 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2020
CompletedJanuary 4, 2023
December 1, 2022
10 months
March 29, 2019
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
EXPERIMENTALParticipants 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.
Galactose alone
EXPERIMENTALParticipants 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.
Glucose and galactose
EXPERIMENTALParticipants 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.
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.
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.
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.
Eligibility Criteria
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
- University of Birminghamlead
- Dairy Management Inc.collaborator
Study Sites (1)
School of Sport, Exercise and Rehabilitation Sciences
Birmingham, West Midlands, B15 2TT, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gareth Wallis, PhD
University of Birmingham
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