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临床试验/NCT03891927
NCT03891927Unknown不适用

Effect of Extra Virgin Olive Oil on Glycemic Control ,Insulin Resistance and Insulin Secretion in Patients With Type 2 Diabetes

Assiut University0 个研究点目标入组 80 人开始时间: 2019年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
80
主要终点
change of HBa1c (glycated hemoglobin) after intervention by extra virgin olive oil

研究概览

简要总结

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.

详细描述

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 .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

olive group

Experimental

During the experimental period (3 months ), participants will be requested to consume daily dose of 30 mL (3 tablespoons) of HP-EVOO ( high polypheol Extra virgin olive oil)

干预措施: extra virgin olive oil (Dietary Supplement)

non olive group

No Intervention

No intervention

结局指标

主要结局

change of HBa1c (glycated hemoglobin) after intervention by extra virgin olive oil

时间窗: 3 months

change of HBa1c (glycated hemoglobin) after intervention by 30 ml extra virgin olive oil daily for three months and comparison that with other group (no intervention of olive oil) to evaluate glycemic control . measurment of HBa1c for group of intervention at baseline and after 3 months intervention . and other group (no intervention of olive oil) at baseline and after 3 months.

change of fasting glucose after intervention by extra virgin olive oil

时间窗: 3 months

change of fasting glucose after intervention by 30 ml extra virgin olive oil daily for three months and comparison that with other group (no intervention of olive oil) to evaluate glycemic control . measurment of fasting glucose for group of intervention at baseline and after 3 months intervention . and other group (no intervention of olive oil) at baseline and after 3 months.

次要结局

  • reduction of body mass index .(3 months)
  • changing in waist circumference .(3 months follow up)
  • change at Lipid profile (cholesterol, TG, LDL, HDL) after intervention .(3 months follow up)
  • calculating of insulin resistance and insulin secretion after intervention by extra virgin olive oil(3 months.)
  • reduction of systolic and diastolic blood pressure after intervention by extra virgin olive oil .(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aml Ali Aboelghait

Assistant Lecturer

Assiut University

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