Gene ExpressionDGENESNCT01806441
Impact of a Short-Term High Fat or Low Fat Diet on Intestinal Genes Expression Involved in the Cholesterol and Fatty Acid Metabolism
A study testing 3-days high fat diet and 3-days low fat diet in people with Gene Expression, run by Laval University at 1 site in Canada.
Trial summary
Dietary fat has been shown to modulate cholesterol and fatty acids homeostasis and several lines of evidence suggest that this effect is associated with changes in the regulation of different genes at the intestine level involved in the cholesterol and fatty acid metabolism pathways. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Gene Expression
- What is being tested?
- 3-days high fat diet and 3-days low fat diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2009to Dec 2010
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males 18 to 50 years of age
- Non-smoker
- Body mass index between 20.0 and 30.0 kg/m2
- Plasma LDL-cholesterol levels between the 25th and 75th percentile for their age at day -14
- Plasma triglyceride levels < 1.7 mmol/L (150 mg/dl) at day -14
- Plasma HDL-cholesterol levels between 0.9 (35 mg/dl) and 1.6 mmol/L (60 mg/dl) at day -14
- Subjects must be willing to give written informed consent and able to adhere to the diet schedule and visit schedule
- Patients should be otherwise healthy, without elevations in hepatic transaminases or creatine kinase (CK) or abnormal renal function or coagulation
Who cannot join
- Patients with extreme dyslipidemias, such as familial hypercholesterolemia will be excluded
- Subjects will be excluded if they have cardiovascular disease (CHD, cerebrovascular disease or peripheral arterial disease) or if they are taking other medications known to affect lipoprotein metabolism (eg. steroids, beta blockers, thiazide diuretics, other lipid lowering agents, significant alcohol intake etc.)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institute of nutrition and functional food
Québec, Quebec, G1V 0A6
About this study
Official title: Impact of a Short-Term High Fat Diet Versus A Short-Term Low Fat Diet on Expression of the Key Intestinal Genes Involved in the Cholesterol and Fatty Acid Metabolism Pathways
Dietary fat has been shown to modulate cholesterol and fatty acids homeostasis and several lines of evidence suggest that this effect is associated with changes in the regulation of different genes at the intestine level involved in the cholesterol and fatty acid metabolism pathways. The present study will examine the impact of a short-term high fat diet versus a short-term low fat diet on expression of Niemann-Pick C1-like 1 (NPC1L1), adenosine triphosphate (ATP) binding cassette transporters (ABCG5/8), microsomal triglyceride transfer protein (MTP) and fatty acid transport protein-4 (FATP4), which have been shown to play a critical role in intestinal cholesterol absorption, chylomicron synthesis and dietary lipid absorption. Gene expression studies will be performed on duodenal biopsies. The primary hypothesis is that a short-term high fat diet will significantly decrease duodenal messenger ribonucleic acid (mRNA) levels of NPC1L1, ABCG5/8, MTP and FATP4 as compared with a short-term low fat diet.
- Conditions
- Gene Expression
- Being tested
- 3-days high fat diet, 3-days low fat diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-days high fat dietOther
During 3 days, subjects eat a diet high in fat (percent of total caloric intake: 15.0% from proteins; 49,8% from carbohydrates; 37.0% from fat).
3-days low fat dietOther
During 3 days, subjects eat a diet low in fat (percent of caloric intake: 15.0% from proteins; 61,8% from carbohydrates; 25.0% from fats).
| Study group | Role | What they receive |
|---|---|---|
| 3-days high fat diet | Experimental | During 3 days, subjects eat a diet high in fat (percent of total caloric intake: 15.0% from proteins; 49,8% from carbohydrates; 37.0% from fat). Receives: Other: 3-days high fat diet |
| 3-days low fat diet | Active comparator | During 3 days, subjects eat a diet low in fat (percent of caloric intake: 15.0% from proteins; 61,8% from carbohydrates; 25.0% from fats). Receives: Other: 3-days low fat diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in duodenal mRNA expression of NPC1L1, ABCG5/8, MTP and FATP4.
Six biopsies (3 X 3 mm) will be obtained from the second portion of the duodenum during gastro-duodenoscopy. Biopsy specimen will be stored at -86°C before mRNA extraction. Total RNA will be isolated and used for polymerase chain reaction (PCR) quantification.
Measured: At the end of the two 3-days diets (day 3 and day 17).
Secondary outcomes (1)
Change in surrogate markers of cholesterol absorption and synthesis.
Measured: At the end of the two 3-days diets (day 3 and day 17).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2013 (estimated)
- Study startFeb 2009
- Primary completionMay 2009
- Study completionDec 2010
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 Gene ExpressionStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Couture, Laval University
- Investigators
- Patrick Couture, MD,FRCP,PhD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01806441
- Sponsor's protocol ID
- INAF-125-05-06
- Acronym
- DGENES
- Status last verified
- Mar 2013
- First submitted
- 4 Mar 2013
- Last updated
- 7 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Tremblay AJ, Lamarche B, Guay V, Charest A, Lemelin V, Couture P. Short-term, high-fat diet increases the expression of key intestinal genes involved in lipoprotein metabolism in healthy men. Am J Clin Nutr. 2013 Jul;98(1):32-41. doi: 10.3945/ajcn.113.060251. Epub 2013 May 29.
PubMed 23719552
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Short-Term High Fat Diet Versus A Short-Term Low Fat Diet on Expression of the Key Intestinal Genes Involved in the Cholesterol and Fatty Acid Metabolism Pathways
- ClinicalTrials.gov ID
- NCT01806441
- Acronym / sponsor ID
- DGENES / INAF-125-05-06
- Conditions
- Gene Expression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- May 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 7 Mar 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.
Dietary fat has been shown to modulate cholesterol and fatty acids homeostasis and several lines of evidence suggest that this effect is associated with changes in the regulation of different genes at the intestine level involved in the cholesterol and fatty acid metabolism pathways. The present study will examine the impact of a short-term high fat diet versus a short-term low fat diet on expression of Niemann-Pick C1-like 1 (NPC1L1), adenosine triphosphate (ATP) binding cassette transporters (ABCG5/8), microsomal triglyceride transfer protein (MTP) and fatty acid transport protein-4 (FATP4), which have been shown to play a critical role in intestinal cholesterol absorption, chylomicron synthesis and dietary lipid absorption. Gene expression studies will be performed on duodenal biopsies. The primary hypothesis is that a short-term high fat diet will significantly decrease duodenal messenger ribonucleic acid (mRNA) levels of NPC1L1, ABCG5/8, MTP and FATP4 as compared with a short-term low fat diet.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3-days high fat diet | Experimental | Other: 3-days high fat dietDuring 3 days, subjects eat a diet high in fat (percent of total caloric intake: 15.0% from proteins; 49,8% from carbohydrates; 37.0% from fat). |
| 3-days low fat diet | Active comparator | Other: 3-days low fat dietDuring 3 days, subjects eat a diet low in fat (percent of caloric intake: 15.0% from proteins; 61,8% from carbohydrates; 25.0% from fats). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Males 18 to 50 years of age
- Non-smoker
- Body mass index between 20.0 and 30.0 kg/m2
- Plasma LDL-cholesterol levels between the 25th and 75th percentile for their age at day -14
- Plasma triglyceride levels < 1.7 mmol/L (150 mg/dl) at day -14
Key exclusion criteria (2 listed)
- Patients with extreme dyslipidemias, such as familial hypercholesterolemia will be excluded
- Subjects will be excluded if they have cardiovascular disease (CHD, cerebrovascular disease or peripheral arterial disease) or if they are taking other medications known to affect lipoprotein metabolism (eg. steroids, beta blockers, thiazide diuretics, other lipid lowering agents, significant alcohol intake etc.)
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 |
|---|---|---|
| 3-days high fat dietDuring 3 days, subjects eat a diet high in fat (percent of total caloric intake: 15.0% from proteins; 49,8% from carbohydrates; 37.0% from fat). | Other | 3-days high fat diet |
| 3-days low fat dietDuring 3 days, subjects eat a diet low in fat (percent of caloric intake: 15.0% from proteins; 61,8% from carbohydrates; 25.0% from fats). | Other | 3-days low fat diet |
Primary outcome
Change in duodenal mRNA expression of NPC1L1, ABCG5/8, MTP and FATP4.
Time frame: At the end of the two 3-days diets (day 3 and day 17).
Six biopsies (3 X 3 mm) will be obtained from the second portion of the duodenum during gastro-duodenoscopy. Biopsy specimen will be stored at -86°C before mRNA extraction. Total RNA will be isolated and used for polymerase chain reaction (PCR) quantification.
1 secondary outcome
Change in surrogate markers of cholesterol absorption and synthesis.
Time frame: At the end of the two 3-days diets (day 3 and day 17).
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 7 Mar 2013.
- Derived from this study: PubMed 23719552Tremblay AJ, Lamarche B, Guay V, Charest A, Lemelin V, Couture P. Short-term, high-fat diet increases the expression of key intestinal genes involved in lipoprotein metabolism in healthy men. Am J Clin Nutr. 2013 Jul;98(1):32-41. doi: 10.3945/ajcn.113.060251. Epub 2013 May 29.
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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.
Patrick Couture, MD,FRCP,PhD principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3-days high fat diet and 3-days low fat diet in people with Gene Expression, run by Laval University at 1 site in Canada.
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 8 inclusion and 2 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 7 Mar 2013. 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 Canada. 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 duodenal mRNA expression of NPC1L1, ABCG5/8, MTP and FATP4. (time frame: At the end of the two 3-days diets (day 3 and day 17).). 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 NCT01806441, 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 7 Mar 2013.