- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01121003
Effects of Fructose and Exercise on Hepatic Lipid Metabolism (FRUCTEXER)
October 18, 2011 updated by: Luc Tappy, MD, University of Lausanne
Effects of a Weight Maintenance, High Fructose Diet and of Exercise on Hepatic Lipid Metabolism
8 healthy male volunteers will be studied each on 3 occasions, ie
- after 4 days on a weight maintenance diet containing 5% simple sugars + low physical activity
- after 4 days on a weight maintenance diet containing 30% fructose + low physical activity
- after 4 days on a weight maintenance diet containing 30% fructose + high physical activity At the end of each of these 3 periods, fructose induced hepatic de novo lipogenesis (13C palmitate synthesis in response to ingestion of a 13C fructose load) and plasma VLDL-triglyceride kinetics (measured with a bolus of 2H-labeled glycerol) will be measured
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Anticipated)
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
-
-
VD
-
Lausanne, VD, 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 30 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- age between 18 and 30 years
- males
- BMI between 19 and 25
- low to moderate physical activity (< 3 sessions/week)
Exclusion Criteria:
- smoking
- consumption of alcohol>50g/week
- consumption of drugs or illicit substances
- food allergies
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: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Low fructose diet/no exercise
|
|
Experimental: high fructose diet/no exercise
|
|
Experimental: high fructose diet+exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hepatic de novo lipogenesis
Time Frame: after 4 days on controlled diet+exercise
|
Measurement of 13C VLDL palmitate after ingestion of 13C fructose
|
after 4 days on controlled diet+exercise
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma VLDL-triglyceride kinetics
Time Frame: after 4 days on controlled diet+exercise
|
Modelling of 2H5-glycerol incorporation in VLDL afetr administration of a bolus of 2H5 glycerol
|
after 4 days on controlled diet+exercise
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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, 2010
Primary Completion (Actual)
October 1, 2011
Study Completion (Actual)
October 1, 2011
Study Registration Dates
First Submitted
May 6, 2010
First Submitted That Met QC Criteria
May 10, 2010
First Posted (Estimate)
May 11, 2010
Study Record Updates
Last Update Posted (Estimate)
October 19, 2011
Last Update Submitted That Met QC Criteria
October 18, 2011
Last Verified
October 1, 2011
More Information
Terms related to this study
Other Study ID Numbers
- Protocole 220/09
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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