ExerciseNCT03903861
Galactose Mediated Glycogen Resynthesis
A study testing Glucose alone, Galactose alone and Glucose and galactose in people with Exercise, run by University of Birmingham at 1 site in United Kingdom.
Trial summary
This study will compare short-term post-exercise muscle glycogen synthesis following combined galactose-glucose, glucose alone or galactose alone ingestion. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise
- What is being tested?
- Glucose alone, Galactose alone and Glucose and galactose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2019to 1 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- Poor recent health as indicated in the general health questionnaire
- Engage in uncommon eating practices (e.g. sustained periods of fasting)
- Diagnosed with galactosemia
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
School of Sport, Exercise and Rehabilitation Sciences
Birmingham, West Midlands, B15 2TT
About this study
Official title: Galactose Mediated Glycogen Resynthesis and the Effects on Metabolism During Subsequent Exercise
This study will compare short-term post-exercise muscle glycogen synthesis following combined galactose-glucose, glucose alone or galactose alone ingestion.
Read the 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.
- Conditions
- Exercise
- Being tested
- Glucose alone, Galactose alone, Glucose and galactose
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose aloneOther
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.
Galactose aloneOther
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.
Glucose and galactoseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Glucose and galactose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle glycogen synthesis rates (mmol/kg/dm/h)
Muscle glycogen synthesis rates over the post-exercise recovery period
Measured: 4 hours
Secondary outcomes (9)
Carbohydrate oxidation rates (g/min)
Total, exogenous and endogenous carbohydrate oxidation during a secondary bout of exercise
Measured: Up to 90 minutes
Fat oxidation rates (g/min)
Fat oxidation during a secondary bout of exercise
Measured: Up to 90 minutes
Plasma glucose (mmol/L)
Plasma glucose during the post-exercise recovery period and during a secondary bout of exercise
Measured: Up to 6 hours
Serum insulin (mU/L)
Serum insulin during the post-exercise recovery period and during a secondary bout of exercise
Measured: Up to 6 hours
Plasma galactose (mmol/L)
Plasma galactose during the post-exercise recovery period and during a secondary bout of exercise
Measured: Up to 6 hours
Plasma lactate (mmol/L)
Plasma lactate during the post-exercise recovery period and during a secondary bout of exercise
Measured: Up to 6 hours
Plasma non-esterified fatty acids (mmol/L)
Plasma non-esterified fatty acids during the post-exercise recovery period and during a secondary bout of exercise
Measured: Up to 6 hours
Plasma glycerol (umol/L)
Plasma glycerol during the post-exercise recovery period and during a secondary bout of exercise
Measured: Up to 6 hours
Plasma glucagon (pmol/L)
Plasma glucagon during the post-exercise recovery period and during a secondary bout of exercise
Measured: Up to 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start1 Jul 2019
- Primary completion1 May 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Dairy Management Inc.
- Responsible party
- Sponsor
- Investigators
- Gareth Wallis, PhD, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03903861
- Sponsor's protocol ID
- ERN_19-0308
- Status last verified
- Dec 2022
- First submitted
- 29 Mar 2019
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Galactose Mediated Glycogen Resynthesis and the Effects on Metabolism During Subsequent Exercise
- ClinicalTrials.gov ID
- NCT03903861
- Acronym / sponsor ID
- ERN_19-0308
- Conditions
- Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- Dairy Management Inc.
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 4 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare short-term post-exercise muscle glycogen synthesis following combined galactose-glucose, glucose alone or galactose alone ingestion.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Glucose alone | Experimental | Other: Glucose aloneParticipants 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 | Experimental | Other: Galactose aloneParticipants 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 | Experimental | Other: Glucose and galactoseParticipants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (9 listed)
- Lidocaine allergy
- Current participation in another scientific/clinical study
- Bleeding disorder/s
- Current or recent smoker to include vaping (last 60 days)
- Vegan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucose aloneYoung 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. | Other | Glucose alone |
| Galactose aloneYoung 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. | Other | Galactose alone |
| Glucose and galactoseYoung 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. | Other | Glucose and galactose |
Primary outcome
Muscle glycogen synthesis rates (mmol/kg/dm/h)
Time frame: 4 hours
Muscle glycogen synthesis rates over the post-exercise recovery period
9 secondary outcomes
Carbohydrate oxidation rates (g/min)
Time frame: Up to 90 minutes
Fat oxidation rates (g/min)
Time frame: Up to 90 minutes
Plasma glucose (mmol/L)
Time frame: Up to 6 hours
Serum insulin (mU/L)
Time frame: Up to 6 hours
Plasma galactose (mmol/L)
Time frame: Up to 6 hours
Plasma lactate (mmol/L)
Time frame: Up to 6 hours
Plasma non-esterified fatty acids (mmol/L)
Time frame: Up to 6 hours
Plasma glycerol (umol/L)
Time frame: Up to 6 hours
Plasma glucagon (pmol/L)
Time frame: Up to 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gareth Wallis, PhD principal investigator
University of Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucose alone, Galactose alone and Glucose and galactose in people with Exercise, run by University of Birmingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle glycogen synthesis rates (mmol/kg/dm/h) (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2023.