Healthy SubjectsFruEx2NCT01866215
Effects of Exercise on Fructose Metabolism
A study testing exercise, fructose and glucose in people with Healthy Subjects, run by University of Lausanne at 1 site in Switzerland.
Trial summary
A high fructose diet increases fasting and post-prandial triglyceride (TG) concentrations in sedentary healthy human subjects.These effects may be secondary to fructose-induced hepatic de novo lipogenesis. Recent evidence indicate that exercise can prevent fructose induced dyslipidemia.This study will evaluate 1. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- exercise, fructose and glucose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2013to Jan 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- males
- 18-40 years old
- 19 kg/m2>BMI>25kg/m2
- moderate to high usual physical activity
- non-smokers
Who cannot join
- family history of diabetes mellitus
- ECG anomaly
- any medication
- participation to blood spending or other clinical study in the 3 months before the beginning of this study
- consumption of drugs
- consumption of more than 50g alcool/week
- family history of food intolerance
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, CH-1011
About this study
A high fructose diet increases fasting and post-prandial triglyceride (TG) concentrations in sedentary healthy human subjects.These effects may be secondary to fructose-induced hepatic de novo lipogenesis. Recent evidence indicate that exercise can prevent fructose induced dyslipidemia.This study will evaluate
- how exercise effects the metabolic fate of oral fructose 1a) when exercise is performed before fructose ingestion 1b) when exercise is performed after fructose ingestion Metabolic effects of exercise will be assessed in healthy male subjects by measuring fructose oxidation (13CO2 production), fructose conversion into glucose (13C glucose concentrations in blood) and hepatic fructose conversion into lipid (13C palmitate-very low density lipoprotein (VLDL) concentrations in blood) after ingestion of 13C-labelled fructose meals
- how fructose and protein modulate muscle glycogen and intramyocellular lipid repletion after exercise Healthy male subjects will be fed various fructose, glucose, lipid and whey protein meals after a glycogen/intramyocellular lipid depleting exercise. The effects of meals' composition will be assessed after 24 hours by measuring intramyocellular lipids and glycogen using proton-magnetic resonance spectroscopy (MRS).
- Conditions
- Healthy Subjects
- Being tested
- exercise, fructose, glucose
- Keywords
- gluconeogenesis, de novo lipogenesis, intramyocellular lipids, muscle glycogen, fructose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseOther
cycling at 100W during 60 min
fructoseDietary supplement
isocaloric nutrition with fructose, cream and whey protein during the 24 hour following a glycogen/intramyocellular lipid depleting exercise
glucoseDietary supplement
isocaloric nutrition with glucose, cream and whey protein during the 24 hour following a glycogen/intramyocellular lipid depleting exercise
| Study group | Role | What they receive |
|---|---|---|
| Study1a | Experimental | exercice performed 90 min before 13C fructose meal ingestion Receives: Other: exercise |
| study 1b | Experimental | exercise performed 90 min after 13C fructose meal ingestion Receives: Other: exercise |
| study 1c | No intervention | no exercise |
| study 2a | Experimental | meals containing fructose, cream and whey proteins over 24 hours after a glycogen/intramyocellular lipid depleting exercise Receives: Dietary Supplement: fructose |
| study 2b | Active comparator | meals containing glucose, cream and whey proteins over 24 hours after a glycogen/intramyocellular lipid depleting exercise Receives: Dietary Supplement: glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma triglyceride
measurement of total and VLDL-TG concentrations in study 1
Measured: measurements in fasting conditions and every hour from 7:00 am to 4:00 pm (up to 9 hours)
intramyocellular lipids
Measurement by 1H-MRS in muscle vastus lateralis in study 2
Measured: after glycogen/intramyocellular lipid depleting exercise and after 24 hour controlled feeding post exercise
Fructose conversion into lipids
Estimated from 13C palmitate-VLDL concentration
Measured: measured from 7:00 am to 4:00 pm in study 1 (up to 9 hours)
Secondary outcomes (4)
Fructose conversion into glucose
measurements obtained from plasma 13C glucose concentrations and whole body glucose production measured by 6,6 d2 glucose in study 1)
Measured: measured between 7:00 am and 4:oo pm (up to 9 hours)
intramyocellular glycogen concentrations
Measured by 1H-MRS in muscle vastus lateralis in study 2
Measured: after glycogen/intramyocellular lipid depleting exercise and after 24 hour controlled feeding post exercise
fructose oxidation
Calculated from breath 13CO2 production
Measured: measured from 7:00 am to 4:00 pm in study 1 (up to 9 hours)
exogenous lipid oxidation
Lipids ingested will be labeled with 13C-triolein, and exogenous lipid oxidation will be measured from breath 13CO2 production
Measured: measured from 7:00 am to 4:00 pm in study 2 (up to 9 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2013 (estimated)
- Study startMay 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern, Centre Hospitalier Universitaire Vaudois
- Responsible party
- Principal investigator, Luc Tappy, MD, University of Lausanne
- Investigators
- Luc Tappy, MD, Principal investigator, University of Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01866215
- Sponsor's protocol ID
- University of Lausanne
- Acronym
- FruEx2
- Status last verified
- Jun 2014
- First submitted
- 27 May 2013
- Last updated
- 4 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Rosset R, Lecoultre V, Egli L, Cros J, Dokumaci AS, Zwygart K, Boesch C, Kreis R, Schneiter P, Tappy L. Postexercise repletion of muscle energy stores with fructose or glucose in mixed meals. Am J Clin Nutr. 2017 Mar;105(3):609-617. doi: 10.3945/ajcn.116.138214. Epub 2017 Jan 18.
PubMed 28100512Egli L, Lecoultre V, Cros J, Rosset R, Marques AS, Schneiter P, Hodson L, Gabert L, Laville M, Tappy L. Exercise performed immediately after fructose ingestion enhances fructose oxidation and suppresses fructose storage. Am J Clin Nutr. 2016 Feb;103(2):348-55. doi: 10.3945/ajcn.115.116988. Epub 2015 Dec 23.
PubMed 26702120
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 Exercise on Fructose Metabolism
- ClinicalTrials.gov ID
- NCT01866215
- Acronym / sponsor ID
- FruEx2 / University of Lausanne
- Conditions
- Healthy Subjects
- Keywords
- gluconeogenesis, de novo lipogenesis, intramyocellular lipids, muscle glycogen, fructose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of LausanneUniversity, hospital or other
- Collaborators
- University of Bern, Centre Hospitalier Universitaire Vaudois
- Study start
- May 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 31 May 2013 (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.
A high fructose diet increases fasting and post-prandial triglyceride (TG) concentrations in sedentary healthy human subjects.These effects may be secondary to fructose-induced hepatic de novo lipogenesis. Recent evidence indicate that exercise can prevent fructose induced dyslipidemia.This study will evaluate
- how exercise effects the metabolic fate of oral fructose 1a) when exercise is performed before fructose ingestion 1b) when exercise is performed after fructose ingestion Metabolic effects of exercise will be assessed in healthy male subjects by measuring fructose oxidation (13CO2 production), fructose conversion into glucose (13C glucose concentrations in blood) and hepatic fructose conversion into lipid (13C palmitate-very low density lipoprotein (VLDL) concentrations in blood) after ingestion of 13C-labelled fructose meals
- how fructose and protein modulate muscle glycogen and intramyocellular lipid repletion after exercise Healthy male subjects will be fed various fructose, glucose, lipid and whey protein meals after a glycogen/intramyocellular lipid depleting exercise. The effects of meals' composition will be assessed after 24 hours by measuring intramyocellular lipids and glycogen using proton-magnetic resonance spectroscopy (MRS).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Study1a | Experimental | Other: exerciseexercice performed 90 min before 13C fructose meal ingestion |
| study 1b | Experimental | Other: exerciseexercise performed 90 min after 13C fructose meal ingestion |
| study 1c | No intervention | –no exercise |
| study 2a | Experimental | Dietary Supplement: fructosemeals containing fructose, cream and whey proteins over 24 hours after a glycogen/intramyocellular lipid depleting exercise |
| study 2b | Active comparator | Dietary Supplement: glucosemeals containing glucose, cream and whey proteins over 24 hours after a glycogen/intramyocellular lipid depleting exercise |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- males
- 18-40 years old
- 19 kg/m2>BMI>25kg/m2
- moderate to high usual physical activity
- non-smokers
Key exclusion criteria (7 listed)
- family history of diabetes mellitus
- ECG anomaly
- any medication
- participation to blood spending or other clinical study in the 3 months before the beginning of this study
- consumption of drugs
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 |
|---|---|---|
| exercisecycling at 100W during 60 min | Other | Study1a, study 1b |
| fructoseisocaloric nutrition with fructose, cream and whey protein during the 24 hour following a glycogen/intramyocellular lipid depleting exercise | Dietary supplement | study 2a |
| glucoseisocaloric nutrition with glucose, cream and whey protein during the 24 hour following a glycogen/intramyocellular lipid depleting exercise | Dietary supplement | study 2b |
Primary outcome
Plasma triglyceride
Time frame: measurements in fasting conditions and every hour from 7:00 am to 4:00 pm (up to 9 hours)
measurement of total and VLDL-TG concentrations in study 1
intramyocellular lipids
Time frame: after glycogen/intramyocellular lipid depleting exercise and after 24 hour controlled feeding post exercise
Measurement by 1H-MRS in muscle vastus lateralis in study 2
Fructose conversion into lipids
Time frame: measured from 7:00 am to 4:00 pm in study 1 (up to 9 hours)
Estimated from 13C palmitate-VLDL concentration
4 secondary outcomes
Fructose conversion into glucose
Time frame: measured between 7:00 am and 4:oo pm (up to 9 hours)
intramyocellular glycogen concentrations
Time frame: after glycogen/intramyocellular lipid depleting exercise and after 24 hour controlled feeding post exercise
fructose oxidation
Time frame: measured from 7:00 am to 4:00 pm in study 1 (up to 9 hours)
exogenous lipid oxidation
Time frame: measured from 7:00 am to 4:00 pm in study 2 (up to 9 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 Jun 2014.
- Derived from this study: PubMed 28100512Rosset R, Lecoultre V, Egli L, Cros J, Dokumaci AS, Zwygart K, Boesch C, Kreis R, Schneiter P, Tappy L. Postexercise repletion of muscle energy stores with fructose or glucose in mixed meals. Am J Clin Nutr. 2017 Mar;105(3):609-617. doi: 10.3945/ajcn.116.138214. Epub 2017 Jan 18.
- Derived from this study: PubMed 26702120Egli L, Lecoultre V, Cros J, Rosset R, Marques AS, Schneiter P, Hodson L, Gabert L, Laville M, Tappy L. Exercise performed immediately after fructose ingestion enhances fructose oxidation and suppresses fructose storage. Am J Clin Nutr. 2016 Feb;103(2):348-55. doi: 10.3945/ajcn.115.116988. Epub 2015 Dec 23.
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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, MD 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 exercise, fructose and glucose in people with 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 7 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?
Plasma triglyceride (time frame: measurements in fasting conditions and every hour from 7:00 am to 4:00 pm (up to 9 hours)). The study lists 3 primary outcomes in all. 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 NCT01866215, which also lists 2 linked publications.
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.