Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Effect of Extra Virgin Olive Oil on Postprandial Blood Glucose in Type 2 Diabetes Mellitus: A Randomized Controlled Trial
Extra virgin olive oil (EVOO) is known for its cardiovascular effects and its effect on
glucose lowering. However, the effects of EVOO on the blood glucose of Type 2 Diabetes
Mellitus Filipino patients has not been studied. The investigators aimed to determine whether
a significant difference exists in meals containing EVOO versus meals without EVOO among Type
2 Diabetes Mellitus patients.
Thirteen patients were included in this randomized controlled cross-over trial. They were
randomized to receive a meal with or without EVOO followed by a one week wash out period,
where they were given the other intervention. The primary outcome is the trans-meal blood
glucose, which is calculated as the percent change in 2-hour postprandial blood glucose.
During their first visit, the participants were oriented on the conduct of the study. They
were advised to be compliant with their medications throughout the duration of the trial.
On their second visit, participants were asked to do a six to eight-hour overnight fast, and
their fasting blood sugar was drawn. Serum samples were analyzed through the hexokinase
method. The participants were then randomly allocated (first allocation) by the dietician
through a coin toss to receive a standard breakfast without EVOO or a meal admixed with one
tablespoon of EVOO. The standard meals were labeled with serial numbers, and both the
participants and the investigator were blinded to the intervention. The meals were consumed
steadily in 15 to 20 minutes, after which, the food containers were collected to ensure its
full consumption. Breakfast was chosen in order to avoid a second meal bias. The participants
were asked to sit in the waiting area of the laboratory until the 2-hour postprandial blood
sugar was due to be drawn.
After a one-week washout period, the participants were asked to come back for a cross over to
the other treatment arm (second allocation). The participants were given the same test meal
to ensure that that the glycemic index of the food remained constant.
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