ExerciseNCT03731065
Exogenous Oxidation of Fructose-glucose Mixtures During Running
A study testing Fructose-maltodextrin, Fructose-maltodextrin hydrogel and Glucose-maltodextrin in people with Exercise, run by University of Bath at 1 site in United Kingdom.
Trial summary
The aim of this study is to characterise exogenous carbohydrate oxidation rates during exercise, when ingesting glucose (polymers) only, compared to glucose-fructose mixtures, and glucose-fructose mixtures ingested in hydrogel form. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Exercise
- What is being tested?
- Fructose-maltodextrin, Fructose-maltodextrin hydrogel and Glucose-maltodextrin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Oct 2018to 30 Nov 2019
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Maximal oxygen consumption > 50 ml.kg-1.min-1
- > 1 year training in endurance running or triathlon
- No current injury or injury within the last three months
- No history of cardiac or metabolic disease such as coronary heart disease or diabetes
- No current or history of gastrointestinal issues
- Successful completion of the physical activity readiness questionnaire (PAR-Q)
Who cannot join
- Female
- Untrained in endurance running
- Current injury or injury within the past three months
- History of cardiac or metabolic disease such as coronary heart disease or diabetes
- History of or current gastrointestinal issues such as irritable bowel syndrome
- Unable to replicate diet and training for 3 and 5 days respectively prior to each experimental visit.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department for Health, University of Bath
Bath, BA2 7AY
About this study
Official title: Examining Exogenous Carbohydrate Oxidation From Glucose, Multiple Transportable Carbohydrates and Hydrogel Carbohydrate Drinks During Endurance Running
The aim of this study is to characterise exogenous carbohydrate oxidation rates during exercise, when ingesting glucose (polymers) only, compared to glucose-fructose mixtures, and glucose-fructose mixtures ingested in hydrogel form.
- Conditions
- Exercise
- Being tested
- Fructose-maltodextrin, Fructose-maltodextrin hydrogel, Glucose-maltodextrin
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fructose-maltodextrinDietary supplement
Fructose plus maltodextrin in a ratio of 1:1.4, diluted in water to produce a 16% carbohydrate solution.
Fructose-maltodextrin hydrogelDietary supplement
Fructose plus maltodextrin in a ratio of 1:1.4, encapsulated in an alginate-pectin hydrogel diluted in water to produce a 16% carbohydrate solution.
Glucose-maltodextrinDietary supplement
Glucose plus maltodextrin in a ratio of 1:1.4, diluted in water to produce a 16% carbohydrate solution.
| Study group | Role | What they receive |
|---|---|---|
| Fructose-maltodextrin ingestion | Active comparator | Ingestion of fructose and maltodextrin (glucose polymers) at a rate of 90 g carbohydrate per hour during two hours of treadmill running at 60%VO2peak. Receives: Dietary Supplement: Fructose-maltodextrin |
| Fructose-maltodextrin hydrogel ingestion | Experimental | Ingestion of fructose and maltodextrin (glucose polymers) encapsulated in alginate-pectin hydrogel, drinks at a rate of 90 g carbohydrate per hour during two hours of treadmill running at 60%VO2peak. Receives: Dietary Supplement: Fructose-maltodextrin hydrogel |
| Glucose-maltodextrin ingestion | Active comparator | Ingestion of glucose and maltodextrin (glucose polymers) at a rate of 90 g carbohydrate per hour during two hours of treadmill running at 60%VO2peak. Receives: Dietary Supplement: Glucose-maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak exogenous carbohydrate oxidation rate
Peak exogenous carbohydrate oxidation rate during 120 min of treadmill running. Measured using isotope ratio mass spectrometry and reported in grams per minute
Measured: 120 minutes
Secondary outcomes (11)
Total carbohydrate oxidation
Total carbohydrate oxidation during 120 min of treadmill running. Measured using indirect calorimetry and reported in grams.
Measured: 120 minutes
Ratings of gastrointestinal discomfort
Subjective ratings of gastrointestinal discomfort during 120 min of treadmill running. Measured using a 9-item questionnaire on a scale of 1 to 7, where 1 = No discomfort at all and 7 = very severe discomfort.
Items: Stomach; Heartburn; Acid reflux; Nausea; Rumbling; Bloated; Burping; Passing gas; Bowel movement.
Measured: 120 minutes
Total fat oxidation
Total fat oxidation during 120 min of treadmill running. Measured using indirect calorimetry and reported in grams.
Measured: 120 minutes
Plasma insulin concentrations
Plasma insulin concentrations during 120 min of treadmill running. Measured using enzyme-linked immunosorbent assay and reported in pmol/L.
Measured: 120 minutes
Plasma glucose concentrations
Plasma lactate concentrations during 120 min of treadmill running. Measured using colourimetric assay and reported in mmol/L.
Measured: 120 minutes
Plasma lactate concentrations
Plasma lactate concentrations during 120 min of treadmill running. Measured using colourimetric assay and reported in mmol/L.
Measured: 120 minutes
Plasma non-esterified fatty acid concentrations
Plasma insulin concentrations during 120 min of treadmill running. Measured using colourimetric assay and reported in umol/L.
Measured: 120 minutes
Ratings of perceived exertion
Subjective ratings of perceived exertion using the Borg scale (1982) during 120 min of treadmill running. Measured on a scale of 6 to 20, where 6 = no exertion at all, and 20 = maximal exertion.
Measured: 120 minutes
Heart rate
Heart rate during treadmill running measured by telemetry and reported in beats per minute.
Measured: 120 minutes
Rate of oxygen consumption
Rate of oxygen consumption during 120 min of treadmill running. Measured using indirect calorimetry and reported in litres per minute.
Measured: 120 minutes
Rate of carbon dioxide production
Rate of carbon dioxide production during 120 min of treadmill running. Measured using indirect calorimetry and reported in litres per minute.
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start14 Oct 2018
- Primary completion30 Oct 2019
- Study completion30 Nov 2019
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 Bath
- Sponsor type
- University, hospital or other
- Collaborators
- University of Birmingham
- Responsible party
- Principal investigator, Javier Gonzalez, University of Bath
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03731065
- Sponsor's protocol ID
- MSES 17/18-001
- Status last verified
- Dec 2019
- First submitted
- 2 Nov 2018
- Last updated
- 10 Dec 2019
- 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 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Exogenous Carbohydrate Oxidation From Glucose, Multiple Transportable Carbohydrates and Hydrogel Carbohydrate Drinks During Endurance Running
- ClinicalTrials.gov ID
- NCT03731065
- Acronym / sponsor ID
- MSES 17/18-001
- Conditions
- Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of BathUniversity, hospital or other
- Collaborators
- University of Birmingham
- Study start
- 14 Oct 2018 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 6 Nov 2018 (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.
The aim of this study is to characterise exogenous carbohydrate oxidation rates during exercise, when ingesting glucose (polymers) only, compared to glucose-fructose mixtures, and glucose-fructose mixtures ingested in hydrogel form.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fructose-maltodextrin ingestion | Active comparator | Dietary Supplement: Fructose-maltodextrinIngestion of fructose and maltodextrin (glucose polymers) at a rate of 90 g carbohydrate per hour during two hours of treadmill running at 60%VO2peak. |
| Fructose-maltodextrin hydrogel ingestion | Experimental | Dietary Supplement: Fructose-maltodextrin hydrogelIngestion of fructose and maltodextrin (glucose polymers) encapsulated in alginate-pectin hydrogel, drinks at a rate of 90 g carbohydrate per hour during two hours of treadmill running at 60%VO2peak. |
| Glucose-maltodextrin ingestion | Active comparator | Dietary Supplement: Glucose-maltodextrinIngestion of glucose and maltodextrin (glucose polymers) at a rate of 90 g carbohydrate per hour during two hours of treadmill running at 60%VO2peak. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Maximal oxygen consumption > 50 ml.kg-1.min-1
- > 1 year training in endurance running or triathlon
- No current injury or injury within the last three months
- No history of cardiac or metabolic disease such as coronary heart disease or diabetes
- No current or history of gastrointestinal issues
Key exclusion criteria (6 listed)
- Female
- Untrained in endurance running
- Current injury or injury within the past three months
- History of cardiac or metabolic disease such as coronary heart disease or diabetes
- History of or current gastrointestinal issues such as irritable bowel syndrome
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 |
|---|---|---|
| Fructose-maltodextrinFructose plus maltodextrin in a ratio of 1:1.4, diluted in water to produce a 16% carbohydrate solution. | Dietary supplement | Fructose-maltodextrin ingestion |
| Fructose-maltodextrin hydrogelFructose plus maltodextrin in a ratio of 1:1.4, encapsulated in an alginate-pectin hydrogel diluted in water to produce a 16% carbohydrate solution. | Dietary supplement | Fructose-maltodextrin hydrogel ingestion |
| Glucose-maltodextrinGlucose plus maltodextrin in a ratio of 1:1.4, diluted in water to produce a 16% carbohydrate solution. | Dietary supplement | Glucose-maltodextrin ingestion |
Primary outcome
Peak exogenous carbohydrate oxidation rate
Time frame: 120 minutes
Peak exogenous carbohydrate oxidation rate during 120 min of treadmill running. Measured using isotope ratio mass spectrometry and reported in grams per minute
11 secondary outcomes
Total carbohydrate oxidation
Time frame: 120 minutes
Ratings of gastrointestinal discomfort
Time frame: 120 minutes
Total fat oxidation
Time frame: 120 minutes
Plasma insulin concentrations
Time frame: 120 minutes
Plasma glucose concentrations
Time frame: 120 minutes
Plasma lactate concentrations
Time frame: 120 minutes
Plasma non-esterified fatty acid concentrations
Time frame: 120 minutes
Ratings of perceived exertion
Time frame: 120 minutes
Heart rate
Time frame: 120 minutes
Rate of oxygen consumption
Time frame: 120 minutes
Rate of carbon dioxide production
Time frame: 120 minutes
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 10 Dec 2019.
Related trials for Exercise
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fructose-maltodextrin, Fructose-maltodextrin hydrogel and Glucose-maltodextrin in people with Exercise, run by University of Bath 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 6 inclusion and 6 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 10 Dec 2019. 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?
Peak exogenous carbohydrate oxidation rate (time frame: 120 minutes). 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 10 Dec 2019.