MetabolismFRUCTEXERNCT01121003
Effects of Fructose and Exercise on Hepatic Lipid Metabolism
A study testing weight maintenance, low sugar diet, weight maintenance, high fructose diet and weight maintenance, high fructose diet+ exercise in people with Metabolism, run by University of Lausanne at 1 site in Switzerland.
Trial summary
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 +… 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
- Metabolism
- What is being tested?
- weight maintenance, low sugar diet, weight maintenance, high fructose diet and weight maintenance, high fructose diet+ exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2010to Oct 2011
- 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
- age between 18 and 30 years
- males
- BMI between 19 and 25
- low to moderate physical activity (< 3 sessions/week)
Who cannot join
- smoking
- consumption of alcohol>50g/week
- consumption of drugs or illicit substances
- food allergies
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, CH-1011
About this study
Official title: 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
- Conditions
- Metabolism
- Being tested
- weight maintenance, low sugar diet, weight maintenance, high fructose diet, weight maintenance, high fructose diet+ exercise
- Keywords
- Fructose, VLDL-triglycerides, de novo lipogenesis, Human metabolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
weight maintenance, low sugar dietBehavioural
weight maintenance, high fructose dietBehavioural
weight maintenance, high fructose diet+ exerciseBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Low fructose diet/no exercise | Other | Not described Receives: Behavioral: weight maintenance, low sugar diet |
| high fructose diet/no exercise | Experimental | Not described Receives: Behavioral: weight maintenance, high fructose diet |
| high fructose diet+exercise | Experimental | Not described Receives: Behavioral: weight maintenance, high fructose diet+ exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic de novo lipogenesis
Measurement of 13C VLDL palmitate after ingestion of 13C fructose
Measured: after 4 days on controlled diet+exercise
Secondary outcomes (1)
Plasma VLDL-triglyceride kinetics
Modelling of 2H5-glycerol incorporation in VLDL afetr administration of a bolus of 2H5 glycerol
Measured: after 4 days on controlled diet+exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2010 (estimated)
- Study startMay 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MetabolismStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
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, MD, Principal investigator, University of Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01121003
- Sponsor's protocol ID
- Protocole 220/09
- Acronym
- FRUCTEXER
- Status last verified
- Oct 2011
- First submitted
- 6 May 2010
- Last updated
- 19 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Weight Maintenance, High Fructose Diet and of Exercise on Hepatic Lipid Metabolism
- ClinicalTrials.gov ID
- NCT01121003
- Acronym / sponsor ID
- FRUCTEXER / Protocole 220/09
- Conditions
- Metabolism
- Keywords
- Fructose, VLDL-triglycerides, de novo lipogenesis, Human metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- University of LausanneUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Vaudois
- Study start
- May 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 11 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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low fructose diet/no exercise | Other | Behavioral: weight maintenance, low sugar diet |
| high fructose diet/no exercise | Experimental | Behavioral: weight maintenance, high fructose diet |
| high fructose diet+exercise | Experimental | Behavioral: weight maintenance, high fructose diet+ exercise |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age between 18 and 30 years
- males
- BMI between 19 and 25
- low to moderate physical activity (< 3 sessions/week)
Key exclusion criteria (4 listed)
- smoking
- consumption of alcohol>50g/week
- consumption of drugs or illicit substances
- food allergies
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 |
|---|---|---|
| weight maintenance, low sugar diet | Behavioural | Low fructose diet/no exercise |
| weight maintenance, high fructose diet | Behavioural | high fructose diet/no exercise |
| weight maintenance, high fructose diet+ exercise | Behavioural | high fructose diet+exercise |
Primary outcome
Hepatic de novo lipogenesis
Time frame: after 4 days on controlled diet+exercise
Measurement of 13C VLDL palmitate after ingestion of 13C fructose
1 secondary outcome
Plasma VLDL-triglyceride kinetics
Time frame: after 4 days on controlled diet+exercise
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 19 Oct 2011.
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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 weight maintenance, low sugar diet, weight maintenance, high fructose diet and weight maintenance, high fructose diet+ exercise in people with Metabolism, 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 4 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 19 Oct 2011. 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?
Hepatic de novo lipogenesis (time frame: after 4 days on controlled diet+exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2011.