Extra Virgin Olive Oil on Glycemic Control ,Insulin Resistance and Insulin Secretion
Primary Purpose
Insulin Resistance
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
extra virgin olive oil
Sponsored by
About this trial
This is an interventional treatment trial for Insulin Resistance focused on measuring olive oil, glycemic control
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
olive group
non olive group
Arm Description
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)
No intervention
Outcomes
Primary Outcome Measures
change of HBa1c (glycated hemoglobin) after intervention by extra virgin olive oil
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
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.
Secondary Outcome Measures
calculating of insulin resistance and insulin secretion after intervention by extra virgin olive oil
measurement of fasting insulin 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 insulin resistance and insulin secretion by calculating HOMA -IR and HOMA-B The HOMA-beta cell function (HOMA-B) will be calculated by using the following formula: 360 x fasting insulin (μU/mL) / (fasting glucose (mg/dL) - 63).
(HOMA-IR) method: fasting glucose (mg/dl) x fasting insulin / 405
reduction of systolic and diastolic blood pressure after intervention by extra virgin olive oil .
measurement of systolic and diastolic blood pressure after intervention by 30 ml extra virgin olive oil daily for three months and comparison that with other group
reduction of body mass index .
height , weight measuring and calculating BMI.Body mass index (BMI) was calculated as weight (kg) divided by squared height (m).
changing in waist circumference .
waist circumference change will be measured by tape measure at the umbilical level while patients standing after expiration by centimeter after intervention by 30 ml extra virgin olive oil daily for three months
change at Lipid profile (cholesterol, TG, LDL, HDL) after intervention .
change at Lipid profile (cholesterol, TG, LDL, HDL) (cholesterol by mg/dl ,triglyceride by mg/dl ,low density lipoprotein by mg/dl and high density lipoprotein by mg/dl ) after intervention by 30 ml extra virgin olive oil daily for three months and comparison that with other group (no intervention of olive oil)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03891927
Brief Title
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
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2019 (Anticipated)
Primary Completion Date
November 1, 2020 (Anticipated)
Study Completion Date
December 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance
Keywords
olive oil, glycemic control
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized clinicl trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
olive group
Arm Type
Experimental
Arm Description
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)
Arm Title
non olive group
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
extra virgin olive oil
Intervention Description
During the experimental period (3 months ), participants will be requested to consume daily dose of 30 mL (3 tablespoons) of HP-EVOO
Primary Outcome Measure Information:
Title
change of HBa1c (glycated hemoglobin) after intervention by extra virgin olive oil
Description
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.
Time Frame
3 months
Title
change of fasting glucose after intervention by extra virgin olive oil
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
calculating of insulin resistance and insulin secretion after intervention by extra virgin olive oil
Description
measurement of fasting insulin 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 insulin resistance and insulin secretion by calculating HOMA -IR and HOMA-B The HOMA-beta cell function (HOMA-B) will be calculated by using the following formula: 360 x fasting insulin (μU/mL) / (fasting glucose (mg/dL) - 63).
(HOMA-IR) method: fasting glucose (mg/dl) x fasting insulin / 405
Time Frame
3 months.
Title
reduction of systolic and diastolic blood pressure after intervention by extra virgin olive oil .
Description
measurement of systolic and diastolic blood pressure after intervention by 30 ml extra virgin olive oil daily for three months and comparison that with other group
Time Frame
3 months
Title
reduction of body mass index .
Description
height , weight measuring and calculating BMI.Body mass index (BMI) was calculated as weight (kg) divided by squared height (m).
Time Frame
3 months
Title
changing in waist circumference .
Description
waist circumference change will be measured by tape measure at the umbilical level while patients standing after expiration by centimeter after intervention by 30 ml extra virgin olive oil daily for three months
Time Frame
3 months follow up
Title
change at Lipid profile (cholesterol, TG, LDL, HDL) after intervention .
Description
change at Lipid profile (cholesterol, TG, LDL, HDL) (cholesterol by mg/dl ,triglyceride by mg/dl ,low density lipoprotein by mg/dl and high density lipoprotein by mg/dl ) after intervention by 30 ml extra virgin olive oil daily for three months and comparison that with other group (no intervention of olive oil)
Time Frame
3 months follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aml Ali Aboelghait, MD
Phone
01021191660
Ext
002
Email
amlaliaboelghait98@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
safaa AA Khaled, MD
Phone
01064170058
Ext
002
Email
safaakhaled2003@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salah Abdelazeem Argoon, professor
Organizational Affiliation
Assiut University
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
28394365
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.
Results Reference
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PubMed Identifier
27344308
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.
Results Reference
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PubMed Identifier
24625239
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.
Results Reference
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PubMed Identifier
27794174
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.
Results Reference
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Extra Virgin Olive Oil on Glycemic Control ,Insulin Resistance and Insulin Secretion
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