Antidiabetic Effect of Olive Pomace Oil

Condition(s) studied

Investigational drug(s) / intervention(s)

Experimental arm: Olive pomace oil: Participants will consume during 8 weeks either the test oil (olive pomace oil) as the only dietary fat. They will consume 45 g/day of oil, using it in salads, fried foods, as spread on toasts, etc.

High-oleic acid sunflower oil: Participants will consume during 8 weeks either the test active comparator oil (high-oleic acid sunflower oil) as the only dietary fat. They will consume 45 g/day of oil, using it in salads, fried foods, as spread on toasts, etc.

Study summary

This clinical trial aims at assessing whether consumption of olive pomace oil in the diet may benefit persons with type 2 diabetes mellitus or persons at risk of developing the disease (prediabetic persons).

The main questions the study aims to answer are:

* May olive pomace oil prevent a high increase of blood glucose levels when consumed in a meal together with carbohydrates in diabetic/prediabetic patients?
* May olive pomace oil decrease fasting blood glucose levels of diabetic/prediabetic patients after consuming it daily?
* May daily consumption of olive pomace oil improve glucose homeostasis and other alterations like elevated blood lipids or inflammation, which also affect persons with diabetes or prediabetes?

Researchers will compare the effect of consuming olive pomace oil to the effects of a comparison oil (high-oleic acid sunflower oil).

Participants will:

In different days, they will consume white bread alone or the oils (olive pomace oil, high-oleic acid sunflower oil or extra virgin olive oil) spread on white bread and blood will be collected at different times during 2 h. This study to observe the increase of blood glucose after a carbohydrate-rich breakfast will be part of the so-called "postprandial" study, and will be conducted during 3 weeks, during which participants will consume corn oil on a daily basis.

Participants will also take part in the "chronic" study, that will last 22 weeks in total. During this study, they will firstly "wash" the effects of the oil they normally consume in their diets by consuming corn oil during 3 weeks. It is during these weeks when they will attend the Human Nutrition Unit (HNU) of ICTAN to carry on the "postprandial" study described in the previous paragraph.

After the initial 3 weeks, participants will consume olive pomace oil as the only oil in their diets during 8 weeks, "wash" its effects again by consuming corn oil during 3 weeks and then change to consume the other oil (high-oleic acid sunflower oil) during 8 weeks.

During the chronic study, they will visit the clinic once every 4 weeks for checkups and tests. They will refrain from eating other oils or specific fat-rich foods. Participants will also attend our phone calls to ask them what they ate the day before on different weeks during the study, and wear an accelerometer during 1 week to record their physical activity. They will keep a diary of the doses of insulin/metformin used and the blood glucose levels they measured at home.

Eligibility

Primary outcome measure(s)

• Fasting blood glucose — From enrollment to the end of each treatment at 8 weeks
  Change of fasting blood glucose levels at the end of the chronic intervention
• Postprandial blood glucose response — From enrollment until week 14 of the study
  Change of postprandial blood glucose levels after consuming white bread with oil in comparison with white bread only. Blood will be collected at 0 h and 1 and 2 h after consuming the bread alone or with the corresponding oil. Olive pomace oil (active comparator) and high-oleic acid sunflower oil (active comparator) will be tested. Only in this postprandial study extra virgin olive oil will also be tested as a positive control (at the beginning of the run-in), along with white bread only (at week 2 of the run-in). Test/comparator oils will be assessed at the beginning of each arm, week 1 of each intervention arm (corresponding to weeks 4 and 14 of the study).

Trial sites (1)

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