A Clinical Study to Assess Postprandial Metabolism Using an Oral Stable Isotope in Healthy Male Subjects
This is a randomized, four-period crossover study to assess the test characteristics of measuring isotope-enriched TG excursions (AUC) after ingestion of a liquid fat challenge with stable isotope in 12 healthy volunteers. Up to 4 weeks following a screening visit, eligible subjects will be randomized to receive a series of 4 postprandial lipemia tests, each separated by 2 weeks. The postprandial lipemia tests will include a fat challenge with tracer followed by blood collections at intervals over 8 hours. There will be 3 different levels of fat (high, moderate and low) that contain a proportion of tracer that is consistent amongst the 3 levels of fat challenge. The high fat challenge will be repeated
in each subject to assess repeatability.
1. Subject is male and ≥ 18 and ≤ 40 years of age at the prestudy visit.
2. The subject is judged to be in general good health, based on medical history, physical
examination, vital signs and laboratory tests performed at the prestudy visit.
3. At the prestudy visit, subject has a brachial systolic blood pressure of <160 mmHg
and a brachial diastolic blood pressure of <100 mmHg, obtained from a set of
triplicate blood pressure measurements.
4. Subject has a body mass index (BMI) that is ≥ 20 and < 28 kg/m2 at the prestudy
visit. BMI is calculated by taking the subject’s weight in kg and dividing by the
subject’s height in meters, squared (BMI table provided in Appendix 6.5).
5. Subject is willing to avoid strenuous physical activity (i.e., strenuous or
unaccustomed weight lifting, running, bicycling, etc.) for the duration of the study,
including the domiciled period.
6. Subject agrees to consume ONLY the meals and fluid provided during all domiciled
7. Subject has been a nonsmoker and/or has not used nicotine or nicotine-containing
products for at least approximately 3 months prior to prestudy visit and agrees to
refrain from smoking or use of any tobacco containing products including chewing
tobacco throughout the study.
Note: Non-daily or social smokers who have consumed no greater than an average of
approximately 5 cigarettes or equivalent during the 3-month period prior to prestudy
also may be enrolled at the discretion of the investigator.
8. Subject agrees to refrain from consumption of alcohol starting 48 hours before and
during all domiciled periods until discharge from the CRU. At all other times, during
the study, daily alcohol consumption should not exceed 2 glasses (1 glass is
approximately equivalent to: beer [284 mL/10 ounces], wine [125 mL/4 ounces] or
distilled spirits [25 mL/1 ounce]).
9. Subject agrees to refrain from consumption of caffeine starting 12 hours prior to and
during all domiciled periods until discharge from the CRU. At all other times during
the study, daily caffeine consumption should not exceed 2 cups of coffee (1 cup is
approximately equivalent to 120 mg of caffeine) or equivalent.
10. Subject understands the study procedures and agrees to participate in the study by
giving written informed consent.
11. Subject is willing to comply with the study restrictions.