Normal Physiology on Healthy SubjectsLactExNCT01610986
Effects of Glucose-fructose Drinks During Training on Lactate Transport
A study testing Glucose-fructose and Water in people with Normal Physiology on Healthy Subjects, run by University of Lausanne at 1 site in Switzerland.
Trial summary
The purpose of this study is to determine whether glucose-fructose intake during training increases lactate transport and oxidation and improve endurance performance. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Normal Physiology on Healthy Subjects
- What is being tested?
- Glucose-fructose and Water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2012to Mar 2014
- 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 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy
- age between 18 and 30 years
- sedentary
- BMI between 19 and 25
- blood pressure lower than 140/90 mmHg
Who cannot join
- smoking
- consumption of more than 10g alcohol per day
- cardiovascular history
- electrographic abnormalities at rest
- consumption of more than one can of soda per day or more than 60g sugars per day
- any current drug treatment
Show all 11Show fewer
- consumption of drugs or illicit substances
- diabetes mellitus
- vegetarian
- food intolerance
- blood donation or participation to another study <3 months before study inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Glucose-fructose Drinks During Training on Lactate Transport and Oxidation and on Endurance Performance
The purpose of this study is to determine whether glucose-fructose intake during training increases lactate transport and oxidation and improve endurance performance.
Read the detailed description
The study will enroll 24 healthy male volunteers. After baseline assessment of lactate transport and endurance performance, subjects will be randomized to either a 3-week intervention arm in which they will train with glucose-fructose intake during training, or to a control arm (water during training). After this 3-week intervention, lactate transport and endurance performance will be assessed again.
- Conditions
- Normal Physiology on Healthy Subjects
- Being tested
- Glucose-fructose, Water
- Keywords
- Fructose, Exercise, Lactic acid, Monocarboxylic Acid Transporters
- 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-fructoseDietary supplement
0.8 g/h glucose and 0.5 g/h fructose during training
WaterDietary supplement
Only water intake during training
| Study group | Role | What they receive |
|---|---|---|
| Glucose-fructose | Experimental | Participants will take glucose-fructose drinks during training sessions Receives: Dietary Supplement: Glucose-fructose |
| Water | Experimental | Participants will take only water during training sessions Receives: Dietary Supplement: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lactate transport
Measurement of lactate production, utilization, oxidation and clearance during a 90 min cycling exercise at 50% VO2 max (measured with 13C-lactate)
Measured: At baseline (before training) and after the 3-week training protocol
Secondary outcomes (1)
Change in muscle monocarboxylate transporters (MCTs) expression and protein content
MCTs expression (mRNA) and protein content after muscle biopsy
Measured: At baseline (before training) and after the 3-week training protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionMar 2014
- Study completionMar 2014
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 Normal Physiology on Healthy SubjectsStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Vaudois
- Responsible party
- Principal investigator, Luc Tappy, MD, University of Lausanne
- Investigators
- Luc Tappy, Pr, Principal investigator, University of Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01610986
- Sponsor's protocol ID
- 251/11
- Acronym
- LactEx
- Status last verified
- Jun 2014
- First submitted
- 23 May 2012
- Last updated
- 4 Jun 2014
- 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 4 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Glucose-fructose Drinks During Training on Lactate Transport and Oxidation and on Endurance Performance
- ClinicalTrials.gov ID
- NCT01610986
- Acronym / sponsor ID
- LactEx / 251/11
- Conditions
- Normal Physiology on Healthy Subjects
- Keywords
- Fructose, Exercise, Lactic acid, Monocarboxylic Acid Transporters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of LausanneUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Vaudois
- Study start
- May 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 4 Jun 2012 (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.
The purpose of this study is to determine whether glucose-fructose intake during training increases lactate transport and oxidation and improve endurance performance.
Detailed description
The study will enroll 24 healthy male volunteers. After baseline assessment of lactate transport and endurance performance, subjects will be randomized to either a 3-week intervention arm in which they will train with glucose-fructose intake during training, or to a control arm (water during training). After this 3-week intervention, lactate transport and endurance performance will be assessed again.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glucose-fructose | Experimental | Dietary Supplement: Glucose-fructoseParticipants will take glucose-fructose drinks during training sessions |
| Water | Experimental | Dietary Supplement: WaterParticipants will take only water during training sessions |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- healthy
- age between 18 and 30 years
- sedentary
- BMI between 19 and 25
- blood pressure lower than 140/90 mmHg
Key exclusion criteria (11 listed)
- smoking
- consumption of more than 10g alcohol per day
- cardiovascular history
- electrographic abnormalities at rest
- consumption of more than one can of soda per day or more than 60g sugars per day
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-fructose0.8 g/h glucose and 0.5 g/h fructose during training | Dietary supplement | Glucose-fructose |
| WaterOnly water intake during training | Dietary supplement | Water |
Primary outcome
Change in lactate transport
Time frame: At baseline (before training) and after the 3-week training protocol
Measurement of lactate production, utilization, oxidation and clearance during a 90 min cycling exercise at 50% VO2 max (measured with 13C-lactate)
1 secondary outcome
Change in muscle monocarboxylate transporters (MCTs) expression and protein content
Time frame: At baseline (before training) and after the 3-week training protocol
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 Jun 2014.
- Background: 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.
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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.
Luc Tappy, Pr principal investigator
University of Lausanne
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-fructose and Water in people with Normal Physiology on Healthy Subjects, 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 5 inclusion and 11 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 Jun 2014. 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?
Change in lactate transport (time frame: At baseline (before training) and after the 3-week training protocol). 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 NCT01610986, 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 4 Jun 2014.