Carbohydrate Metabolism at ExerciseNCT01128647
Disposal of Oral Fructose During Exercise
An observational study of Carbohydrate Metabolism at Exercise, run by University of Lausanne at 1 site in Switzerland.
Trial summary
There is evidence that total carbohydrate oxidation during exercise is higher after ingestion of fructose:glucose mixture than after ingestion of equimolar amounts of glucose alone. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Carbohydrate Metabolism at Exercise
- What is being tested?
- Fructose:glucose drink and glucose drink
- How many people
- 7 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2009to Mar 2010
- Phase
- Observational
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Healthy, endurance trained male volunteers
Who may be able to join
- age between 18 and 35 years
- males
- good physical health
- weekly cycling training sessions (> 3 sessions/week)
Who cannot join
- diabetes or glucose intolerance
- past history of heart disease
- alcohol intake > 30 g/day
- smokers
- drug consumption
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre Hospitalier Universitaire Vaudois
Lausanne, CH-1011
About this study
There is evidence that total carbohydrate oxidation during exercise is higher after ingestion of fructose:glucose mixture than after ingestion of equimolar amounts of glucose alone. This may possible contribute to improve performance, provided that the extra carbohydrate oxidation induced by fructose:glucose co-ingestion occurs in skeletal muscle. The present study aims at assessing the hypothesis that, during exercise, a substantial portion of oral fructose is converted into lactate prior to oxidation To identify the major pathways of fructose disposal, 7 healthy endurance trained male volunteers will be studied. For each participant the following measurement will be performed
- a measurement of maximal oxygen consumption (VO2 max) on an ergometric bicycle
- a 2 hour exercise protocol with oral administration of a glucose drink. 6,6-2H2 glucose (0.44 µmol/kg/min) and 13C3 lactate (2.25 µmol/kg/min) will be infused to calculate glucose and lactate kinetics. Indirect calorimetry will be performed to measure total carbohydrate oxidation and expired 13CO2 will be monitored to calculate whole body lactate oxidation
- a 2 hour exercise protocol with oral administration of a glucose:fructose (72 + 48 g every hour) mixture. 6,6-2H2 glucose (0.44 µmol/kg/min) and 13C3 lactate (2.25 µmol/kg/min) will be infused to calculate glucose and lactate kinetics. Indirect calorimetry will be performed to measure total carbohydrate oxidation and expired 13CO2 will be monitored to calculate whole body lactate oxidation
- a 2 hour exercise protocol with oral administration of a glucose:fructose (72 + 48 g every hour) mixture with fructose labelled with 13C6 fructose to evaluate exogenous fructose metabolic fate and oxidation. 6,6-2H2 glucose (0.44 µmol/kg/min) will be infused to calculate glucose kinetics. Fructose conversion into lactate and glucose will be evaluated by monitoring the systemic appearance of plasma 13C-labelled lactate and 13C-labelled glucose. Total exogenous fructose oxidation will be measured by monitoring 13CO2 production.
Based on these measurements, semi-quantitative estimates of total fructose oxidation, fructose conversion into glucose, fructose conversion into lactate, and oxidation of fructose-derived lactate will be obtained
- Conditions
- Carbohydrate Metabolism at Exercise
- Being tested
- Fructose:glucose drink, glucose drink
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fructose:glucose drinkDietary supplement
glucose drinkDietary supplement
What is being measured
The primary outcome is the main question the study is designed to answer.
Fructose conversion into lactate
Measured: during a 2 hour-exercise at 60% VO2 max
Secondary outcomes (3)
Total exogenous fructose oxidation
Measured: during a 2 hour-exercise at 60% VO2 max
Fructose conversion into glucose
Measured: during a 2 hour-exercise at 60% VO2 max
Oxidation of lactate derived from fructose
Measured: during a 2 hour-exercise at 60% VO2 max
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2010 (estimated)
- Study startApr 2009
- Primary completionDec 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carbohydrate Metabolism at 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
- Observational
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luc Tappy, MD, University of Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01128647
- Sponsor's protocol ID
- Protocole 59/09
- Status last verified
- Feb 2013
- First submitted
- 21 May 2010
- Last updated
- 13 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Lecoultre V, Benoit R, Carrel G, Schutz Y, Millet GP, Tappy L, Schneiter P. Fructose and glucose co-ingestion during prolonged exercise increases lactate and glucose fluxes and oxidation compared with an equimolar intake of glucose. Am J Clin Nutr. 2010 Nov;92(5):1071-9. doi: 10.3945/ajcn.2010.29566. Epub 2010 Sep 8.
PubMed 20826630
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disposal of Oral Fructose During Exercise
- ClinicalTrials.gov ID
- NCT01128647
- Acronym / sponsor ID
- Protocole 59/09
- Conditions
- Carbohydrate Metabolism at Exercise
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of LausanneUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 24 May 2010 (estimated)
- 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.
There is evidence that total carbohydrate oxidation during exercise is higher after ingestion of fructose:glucose mixture than after ingestion of equimolar amounts of glucose alone. This may possible contribute to improve performance, provided that the extra carbohydrate oxidation induced by fructose:glucose co-ingestion occurs in skeletal muscle. The present study aims at assessing the hypothesis that, during exercise, a substantial portion of oral fructose is converted into lactate prior to oxidation To identify the major pathways of fructose disposal, 7 healthy endurance trained male volunteers will be studied. For each participant the following measurement will be performed
- a measurement of maximal oxygen consumption (VO2 max) on an ergometric bicycle
- a 2 hour exercise protocol with oral administration of a glucose drink. 6,6-2H2 glucose (0.44 µmol/kg/min) and 13C3 lactate (2.25 µmol/kg/min) will be infused to calculate glucose and lactate kinetics. Indirect calorimetry will be performed to measure total carbohydrate oxidation and expired 13CO2 will be monitored to calculate whole body lactate oxidation
- a 2 hour exercise protocol with oral administration of a glucose:fructose (72 + 48 g every hour) mixture. 6,6-2H2 glucose (0.44 µmol/kg/min) and 13C3 lactate (2.25 µmol/kg/min) will be infused to calculate glucose and lactate kinetics. Indirect calorimetry will be performed to measure total carbohydrate oxidation and expired 13CO2 will be monitored to calculate whole body lactate oxidation
- a 2 hour exercise protocol with oral administration of a glucose:fructose (72 + 48 g every hour) mixture with fructose labelled with 13C6 fructose to evaluate exogenous fructose metabolic fate and oxidation. 6,6-2H2 glucose (0.44 µmol/kg/min) will be infused to calculate glucose kinetics. Fructose conversion into lactate and glucose will be evaluated by monitoring the systemic appearance of plasma 13C-labelled lactate and 13C-labelled glucose. Total exogenous fructose oxidation will be measured by monitoring 13CO2 production.
Based on these measurements, semi-quantitative estimates of total fructose oxidation, fructose conversion into glucose, fructose conversion into lactate, and oxidation of fructose-derived lactate will be obtained
Study design
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy, endurance trained male volunteers
Key inclusion criteria (4 listed)
- age between 18 and 35 years
- males
- good physical health
- weekly cycling training sessions (> 3 sessions/week)
Key exclusion criteria (5 listed)
- diabetes or glucose intolerance
- past history of heart disease
- alcohol intake > 30 g/day
- smokers
- drug consumption
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:glucose drink | Dietary supplement | – |
| glucose drink | Dietary supplement | – |
Primary outcome
Fructose conversion into lactate
Time frame: during a 2 hour-exercise at 60% VO2 max
3 secondary outcomes
Total exogenous fructose oxidation
Time frame: during a 2 hour-exercise at 60% VO2 max
Fructose conversion into glucose
Time frame: during a 2 hour-exercise at 60% VO2 max
Oxidation of lactate derived from fructose
Time frame: during a 2 hour-exercise at 60% VO2 max
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 13 Feb 2013.
- Derived from this study: PubMed 20826630Lecoultre V, Benoit R, Carrel G, Schutz Y, Millet GP, Tappy L, Schneiter P. Fructose and glucose co-ingestion during prolonged exercise increases lactate and glucose fluxes and oxidation compared with an equimolar intake of glucose. Am J Clin Nutr. 2010 Nov;92(5):1071-9. doi: 10.3945/ajcn.2010.29566. Epub 2010 Sep 8.
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?
An observational study of Carbohydrate Metabolism at Exercise, run by University of Lausanne at 1 site in Switzerland.
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 4 inclusion and 5 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 13 Feb 2013. 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 Switzerland. 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?
Fructose conversion into lactate (time frame: during a 2 hour-exercise at 60% VO2 max). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01128647, which also lists 1 linked publication.
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 13 Feb 2013.