- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03903861
Galactose Mediated Glycogen Resynthesis
Galactose Mediated Glycogen Resynthesis and the Effects on Metabolism During Subsequent Exercise
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Lactose, the sugar contained within milk, consists of glucose and galactose. Post-exercise consumption of a carbohydrate mixture containing glucose with galactose has been shown to accelerate liver glycogen repletion as compared to glucose-only provision. However, the extent to which galactose-glucose combinations influence post-exercise muscle glycogen storage has yet to be determined.
Therefore, this study will investigate whether short-term muscle glycogen storage after strenuous endurance exercise is enhanced by combined galactose-glucose or glucose only ingestion as compared to the ingestion of galactose alone.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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West Midlands
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Birmingham, West Midlands, United Kingdom, B15 2TT
- School of Sport, Exercise and Rehabilitation Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:.
- 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)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Glucose alone
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.
|
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.
|
|
Experimental: Galactose alone
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.
|
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.
|
|
Experimental: Glucose and galactose
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.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle glycogen synthesis rates (mmol/kg/dm/h)
Time Frame: 4 hours
|
Muscle glycogen synthesis rates over the post-exercise recovery period
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4 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Carbohydrate oxidation rates (g/min)
Time Frame: Up to 90 minutes
|
Total, exogenous and endogenous carbohydrate oxidation during a secondary bout of exercise
|
Up to 90 minutes
|
|
Fat oxidation rates (g/min)
Time Frame: Up to 90 minutes
|
Fat oxidation during a secondary bout of exercise
|
Up to 90 minutes
|
|
Plasma glucose (mmol/L)
Time Frame: Up to 6 hours
|
Plasma glucose during the post-exercise recovery period and during a secondary bout of exercise
|
Up to 6 hours
|
|
Serum insulin (mU/L)
Time Frame: Up to 6 hours
|
Serum insulin during the post-exercise recovery period and during a secondary bout of exercise
|
Up to 6 hours
|
|
Plasma galactose (mmol/L)
Time Frame: Up to 6 hours
|
Plasma galactose during the post-exercise recovery period and during a secondary bout of exercise
|
Up to 6 hours
|
|
Plasma lactate (mmol/L)
Time Frame: Up to 6 hours
|
Plasma lactate during the post-exercise recovery period and during a secondary bout of exercise
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Up to 6 hours
|
|
Plasma non-esterified fatty acids (mmol/L)
Time Frame: Up to 6 hours
|
Plasma non-esterified fatty acids during the post-exercise recovery period and during a secondary bout of exercise
|
Up to 6 hours
|
|
Plasma glycerol (umol/L)
Time Frame: Up to 6 hours
|
Plasma glycerol during the post-exercise recovery period and during a secondary bout of exercise
|
Up to 6 hours
|
|
Plasma glucagon (pmol/L)
Time Frame: Up to 6 hours
|
Plasma glucagon during the post-exercise recovery period and during a secondary bout of exercise
|
Up to 6 hours
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Gareth Wallis, PhD, University of Birmingham
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ERN_19-0308
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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