Extra Virgin Olive Oil on Glycemic Control ,Insulin Resistance and Insulin Secretion

NCT03891927 | Unknown

• 1 other identifier: olive oil on glycemic control
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Insulin Resistance

Keywords

olive oil; glycemic control

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  3 months

Secondary Outcomes (5)

• 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

• 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

Study Arms (2)

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)

Dietary Supplement: extra virgin olive oil

non olive group

NO INTERVENTION

No intervention

Interventions

extra virgin olive oil DIETARY_SUPPLEMENT

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

olive group

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (4)

• 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.

  PMID: 28394365 BACKGROUND

• 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.

  PMID: 27344308 BACKGROUND

• 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.

  PMID: 24625239 BACKGROUND

• 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.

  PMID: 27794174 BACKGROUND

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Salah Abdelazeem Argoon, professor

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Aml Ali Aboelghait, MD

CONTACT

01021191660; amlaliaboelghait98@yahoo.com

safaa AA Khaled, MD

CONTACT

01064170058; safaakhaled2003@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Model Details: randomized clinicl trial

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: March 27, 2019
• Study Start: May 1, 2019
• Primary Completion: November 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 1, 2019

Record last verified: 2019-03