- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01866215
Effects of Exercise on Fructose Metabolism (FruEx2)
June 3, 2014 updated by: Luc Tappy, MD, University of Lausanne
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Vaud
-
Lausanne, Vaud, Switzerland, CH-1011
- Centre Hospitalier Universitaire Vaudois
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- males
- 18-40 years old
- 19 kg/m2>BMI>25kg/m2
- moderate to high usual physical activity
- non-smokers
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Study1a
exercice performed 90 min before 13C fructose meal ingestion
|
cycling at 100W during 60 min
|
Experimental: study 1b
exercise performed 90 min after 13C fructose meal ingestion
|
cycling at 100W during 60 min
|
No Intervention: study 1c
no exercise
|
|
Experimental: study 2a
meals containing fructose, cream and whey proteins over 24 hours after a glycogen/intramyocellular lipid depleting exercise
|
isocaloric nutrition with fructose, cream and whey protein during the 24 hour following a glycogen/intramyocellular lipid depleting exercise
|
Active Comparator: study 2b
meals containing glucose, cream and whey proteins over 24 hours after a glycogen/intramyocellular lipid depleting exercise
|
isocaloric nutrition with glucose, cream and whey protein during the 24 hour following a glycogen/intramyocellular lipid depleting exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
measurements in fasting conditions and every hour from 7:00 am to 4:00 pm (up to 9 hours)
|
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
|
after glycogen/intramyocellular lipid depleting exercise and after 24 hour controlled feeding post exercise
|
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
|
measured from 7:00 am to 4:00 pm in study 1 (up to 9 hours)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fructose conversion into glucose
Time Frame: measured between 7:00 am and 4:oo pm (up to 9 hours)
|
measurements obtained from plasma 13C glucose concentrations and whole body glucose production measured by 6,6 d2 glucose in study 1)
|
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
|
Measured by 1H-MRS in muscle vastus lateralis in study 2
|
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)
|
Calculated from breath 13CO2 production
|
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)
|
Lipids ingested will be labeled with 13C-triolein, and exogenous lipid oxidation will be measured from breath 13CO2 production
|
measured from 7:00 am to 4:00 pm in study 2 (up to 9 hours)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Egli 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2013
Primary Completion (Actual)
January 1, 2014
Study Completion (Actual)
January 1, 2014
Study Registration Dates
First Submitted
May 27, 2013
First Submitted That Met QC Criteria
May 30, 2013
First Posted (Estimate)
May 31, 2013
Study Record Updates
Last Update Posted (Estimate)
June 4, 2014
Last Update Submitted That Met QC Criteria
June 3, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- University of Lausanne
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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