Clinical trial NCT03891927: Extra Virgin Olive Oil on Glycemic Control ,Insulin Resistance and Insulin Secretion
Official title: Effect of Extra Virgin Olive Oil on Glycemic Control ,Insulin Resistance and Insulin Secretion in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insulin Resistance
Keywords: olive oil
glycemic control
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-03-27
Enrollment: 80
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized clinicl trial
Primary purpose: TREATMENT

Brief summary: Aim of this study to evaluate the effects of extra virgin olive oil on glycemic control ,insulin resistance and insulin secretion in patients with Type 2 diabetics.

Detailed description: Diabetes is a major health problem and one of the leading causes of morbidity and mortality worldwide. Lifestyle and particularly dietary habits are considered key issues in both the prevention and management of the disease aimed at achieving an adequate glycemic control or at delaying the onset of diabetic chronic complications .

Olive oil (OO) has been recognized for centuries for its nutritional properties and considered as the "elixir of youth and health" by antique Greeks. Extra virgin olive oil is the main source of dietary fat in the Mediterranean diet . Consumption of extra virgin olive oil might exert beneficial effects in the prevention, development and progression of T2D compared with refined olive oil .

Several bioactive ingredients within OO have been repeatedly linked with anti-oxidant and anti-inflammatory preventative functions, particularly those from monounsaturated fatty acids (MUFA), and key biophenols such as oleuropein and hydroxytyrosol (HT) . Biophenols may influence glucose metabolism via several mechanisms; inhibition of carbohydrate digestion and glucose absorption in the intestine, activation of insulin receptors and glucose uptake in the tissues, antioxidative properties, potent free-radical scavenging and immunomodulatory effects. Multiple studies proven that EVOO improve metabolic control by affection of adipokines .The inhibition of carbohydrate digestion and absorption takes place through an inhibition of some digestive enzymes, especially the carbohydrate-hydrolyzing enzymes α-amylase and α glucosidase. Inhibition of these enzymes retards carbohydrate digestion, thus causing a reduction in glucose absorption rate .With their antioxidative properties, polyphenols diminish the production of advanced glycosylated end products such as HbA1c, AGEs, which are readily formed and accumulated with sustained hyperglycemia, contribute to the development of diabetic complications. As a consequence, inhibition of AGE formation constitutes an attractive therapeutic/preventive target .

Studies both in healthy subjects and in persons with type 2 diabetes mellitus have demonstrated that levels of GLP-1are increased more by dietary MUFA than by dietary saturated fatty acids, and that the greater postprandial clearance of an oral overload of MUFA-rich fats is associated with a greater increase in postprandial incretins such as GLP-1 or gastric inhibitory polypeptide. MUFAs from olive oil, therefore, appear to significantly increase the insulin and GPL-1 secretion .

Eligibility criteria: Inclusion Criteria:

- Patients with type 2 diabetes with

* age 30-60 years regardless of their gender.
* Duration of diabetes less than 5 years.
* on oral antihyperglycemic medication.
* willing to participate in research.

Exclusion Criteria:

* Type 1 diabetes.
* Insulin treated type 2 DM patients.
* Pregnant women .
* Patients on cholesterol-lowering drugs, steroids and other drugs that affect the fat metabolism.
* Patients on regular (days) supplement that contain olive oil.
* Patients have aversion or allergy to olive oil.
* Smokers .
* Patients have gall bladder disease ,gastrointestinal disease (e.g.malabsorption),liver,kidney,heart and thyroid diseases.

Primary outcomes:
measure: change of HBa1c (glycated hemoglobin) after intervention by extra virgin olive oil
timeFrame: 3 months
measure: change of fasting glucose after intervention by extra virgin olive oil
timeFrame: 3 months
Secondary outcomes:
measure: calculating of insulin resistance and insulin secretion after intervention by extra virgin olive oil
timeFrame: 3 months.
measure: reduction of systolic and diastolic blood pressure after intervention by extra virgin olive oil .
timeFrame: 3 months
measure: reduction of body mass index .
timeFrame: 3 months
measure: changing in waist circumference .
timeFrame: 3 months follow up
measure: change at Lipid profile (cholesterol, TG, LDL, HDL) after intervention .
timeFrame: 3 months follow up
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Salah Abdelazeem Argoon, professor
role: STUDY_DIRECTOR
References:
citation: Schwingshackl L, Lampousi AM, Portillo MP, Romaguera D, Hoffmann G, Boeing H. Olive oil in the prevention and management of type 2 diabetes mellitus: a systematic review and meta-analysis of cohort studies and intervention trials. Nutr Diabetes. 2017 Apr 10;7(4):e262. doi: 10.1038/nutd.2017.12.
citation: Santangelo C, Filesi C, Vari R, Scazzocchio B, Filardi T, Fogliano V, D'Archivio M, Giovannini C, Lenzi A, Morano S, Masella R. Consumption of extra-virgin olive oil rich in phenolic compounds improves metabolic control in patients with type 2 diabetes mellitus: a possible involvement of reduced levels of circulating visfatin. J Endocrinol Invest. 2016 Nov;39(11):1295-1301. doi: 10.1007/s40618-016-0506-9. Epub 2016 Jun 25.
citation: Nigam P, Bhatt S, Misra A, Chadha DS, Vaidya M, Dasgupta J, Pasha QM. Effect of a 6-month intervention with cooking oils containing a high concentration of monounsaturated fatty acids (olive and canola oils) compared with control oil in male Asian Indians with nonalcoholic fatty liver disease. Diabetes Technol Ther. 2014 Apr;16(4):255-61. doi: 10.1089/dia.2013.0178.
citation: Lama A, Pirozzi C, Mollica MP, Trinchese G, Di Guida F, Cavaliere G, Calignano A, Mattace Raso G, Berni Canani R, Meli R. Polyphenol-rich virgin olive oil reduces insulin resistance and liver inflammation and improves mitochondrial dysfunction in high-fat diet fed rats. Mol Nutr Food Res. 2017 Mar;61(3). doi: 10.1002/mnfr.201600418. Epub 2016 Dec 20.