The objective of this study is to compare in obese subjects the effects of fenofibrate (200 mg/day) with those of fish oil (7.2 g/day) on expression of PPARα related genes and metabolic parameters.
ID
Source
Brief title
Condition
- Metabolism disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Expression of PPARα related genes, markers of insulin resistance, serum lipid
and lipoprotein profile and markers of inflammation.
Secondary outcome
not applicable
Background summary
The prevalence of the metabolic syndrome is strongly increasing in developed
countries. Activation of PPARα may have a beneficial effect on several
metabolic processes that are disturbed in subjects with the metabolic syndrome.
PPARα can be activated by fibrates (a drug), but it would be helpful for many
people if these effects could also be achieved with a dietary component. In
this respect, fish oil deserves attention, as many in vitro and animal studies
have suggested that the highly polyunsaturated fatty acids from fish oil are
potent PPARα agonists. However, fibrates have never been compared side-by-side
with fish oil.
Study objective
The objective of this study is to compare in obese subjects the effects of
fenofibrate (200 mg/day) with those of fish oil (7.2 g/day) on expression of
PPARα related genes and metabolic parameters.
Study design
Randomised, double blind, placebo controlled cross over design. The duration of
the experimental periods will be 6 weeks, separated by wash out periods of 2
weeks. Subjects will consume in random order a) 200 mg fenofibrate together
with 7.2 g of sunflower oil placebo and b) 7.2 g fish oil together with 200 mg
placebo cellulose placebo and c) 200 mg cellulose placebo together with 7.2 g
sunflower oil placebo.
Intervention
Subjects will consume in random order a) 200 mg fenofibrate together with 7.2 g
of sunflower oil placebo and b) 7.2 g fish oil together with 200 mg placebo
cellulose placebo and c) 200 mg cellulose placebo together with 7.2 g sunflower
oil placebo. A capsule of fenofibrate or cellulose (100 mg) together with 4
capsules of fish oil or sunflower oil (a 900 mg) have to be taken twice daily,
half an hour before breakfast and half an hour before dinner with a glass of
water.
Study burden and risks
Total time investment for the subjects will be 480 minutes.
Venipuncture and biopsies may cause bruises or a hematoma.
Although risks are minimal, the most common causally related adverse effects of
fibrates are digestive, musculoskeletal and dermatologic of nature.
Fish oil supplements, although generally well tolerated, could have as adverse
side effect a mild gastrointestinal discomfort and a fishy smelling breath
and/or urine.
Universiteitssingel 50
6229 ER Maastricht
Nederland
Universiteitssingel 50
6229 ER Maastricht
Nederland
Listed location countries
Age
Inclusion criteria
Body Mass Index > 27 kg/mw
or waist circumference > 88 cm (women) or >102 cm (men)
Exclusion criteria
- BMI < 27 kg/m2 and waistcircumference <88 cm (women) or <102 cm (men)
- Use of PPARα agonists and / or n-3 / n-6 fatty acid supplements
- Serum cholesterol > 8 mmol/l
- Use of medication that can interact with fenofibrate (study medication), including: HMGCoA reductase inhibitors (statins, eg. lovastatin, pravastatin, simvastatin), anticoagulants (eg. acenocoumarol, phenindione, warfarin)
- Hypersensitivity to (feno)fibrate products
- Active cardiovascular disease like congestive heart failure or recent (<6 months) event (acute myocardial infarction, CVA)
- Pre-existing gallbladder disease
- Diabetes mellitus and anti-diabetic medication (e.g. PPARγ agonists)
- Familial hypercholesterolemia
- Severe medical conditions that might interfere with the study such as epilepsy, asthma, COPD, inflammatory bowel diseases and rheumatoid arthritis.
- Unstable body weight (weight gain or loss > 3 kg in the past three months)
- Impairment of renal function, as evidenced by increased serum creatinine >150 mmol/L
- Hepatic diseases as manifested by ALT, AST, GGT, total bilirubin or ALP > 2 times the upper limit of normal
- Abuse of drugs and/or alcohol
- Pregnant or breast-feeding women
- Participation in another biomedical study within 1 month prior to the start of this study
- Having donated blood (as blood donor) within 1 month prior to start of this study
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2006-005743-28-NL |
| CCMO | NL14699.068.06 |