Antidiabetic Potential of Galician High-phenolic Extra Virgin Olive Oils in Patients With Type 2 Diabetes Mellitus. (OILDIABET)

Antidiabetic Potential of Galician High-phenolic Extra Virgin Olive Oils in Patients With Type 2 Diabetes

Since Galician virgin olive oils have a high content of bioactive phenolic compounds and these are attributed to a large part of the healthy properties of the Mediterranean Diet, our starting hypothesis is that these olive oils could attenuate insulin resistance, improving glycemic control in terms of fasting plasma glucose and/or glycated hemoglobin and insulin sensitivity.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Dietary supplement: EVOO diet supplement

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Ourense, Spain, 32004
    • Beatriz Cancho Grande

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosed with type 2 diabetes mellitus for at least 1 year prior to inclusion.
• Older than 18 years old
• Current treatment with diet and/or oral hypoglycemic agents (biguanides, thiazolindiones, α-glucosidase inhibitors, iDPP4, aGLP-1, iSGLT2).
• Body mass index ≥ 25 kg/m2 and < 40 kg/ m2.

Exclusion Criteria:

• Patients on treatment with insulin, SU or rapid-acting insulin secretagogues.
• History of severe ketosis or hyperglycemic decompensation.
• Pregnancy, pregnancy planning or breastfeeding.
• Body mass index ≥ 25 kg/m2 and < 40 kg/m2.
• Difficulty or great inconvenience in changing eating habits or a low predicted probability of changing eating habits.
• Serious medical condition that may affect the person's ability to participate in a nutritional intervention study (e.g., digestive disease with fat intolerance, malignant disease, or significant neurological, psychiatric, or endocrine disease).
• Any other medical condition considered to limit survival to less than 1 year.
• Immunodeficiency or HIV positive status.
• Illegal drug use, chronic alcoholism or problematic alcohol use or total daily alcohol intake > 80 g/d.
• Participation in any clinical trial or use of any investigational drug within the past year.
• Patients institutionalized for chronic care.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm; For 24 weeks, subjects in this arm will have their diet supplemented, daily, with an amount of 30 ml of EVOO (Extra Virgin Olive Oil). Subjects in this arm will also receive qualitative dietary recommendations for following a healthy diet from the nutritional recommendations for patients with diabetes (Evert et al. (2013). Diabetes Care, 36 (11), 3821-3842.).	Dietary supplement: EVOO diet supplement; For 24 weeks, subjects in intervention arm will have their diet supplemented, daily, with an amount of 30 ml of EVOO (Extra Virgin Olive Oil).
No Intervention: Control arm; Subjects in this arm will receive qualitative dietary recommendations for following a healthy diet from the nutritional recommendations for patients with diabetes (Evert et al. (2013). Diabetes Care, 36 (11), 3821-3842.).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycosylated hemoglobin (HbA1c)		At baseline, at 12 weeks and at 24 weeks
Fasting plasma glucose (FPG)	mg/dl	At baseline, at 12 weeks and at 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	Years	Baseline
Sex at birth	Male/female	Baseline
Cardiovascular Risk Factors	Cardiovascular risk factors from the following list will be indicated: Arterial hypertension: Yes/No Dyslipidemia: Yes/No Smoking: Non-smoker Current smoker Recent ex-smoker (<1year) Former smoker (≥1year)	Baseline
Hepatic dysfunction	Yes/No	Baseline
Previous heart disease	Yes/No	Baseline
Heart failure	Yes/No	Baseline
Coronary Heart Disease	Yes/No If yes, answer the following questions: Acute coronary syndrome: Yes/No; Coronary revascularization: Yes/No	Baseline
Concomitant pharmacological treatment	The concomitant pharmacological treatment will be indicated by marking the appropriate one in the following list: Diuretics: Yes/No Mineralcorticoid receptor antagonists: Yes/No ACE inhibitors: Yes/No ARBs2: Yes/No Sacubitril/Valsartan: Yes/No Ivabradin: Yes/No Statins: Yes/No AntiPCSK9: Yes/No Ezetimibe: Yes/No Fibrates: Yes/No Antiaggregants: Yes/No Anticoagulants: Yes/No Beta-blockers: Yes/No Calcium antagonists: Yes/No Antiarrhythmics: Yes/No	Baseline
Antidiabetic treatment	Antidiabetic treatment: Yes/No If Yes, will indicate which of the following list: Metformin: Yes/No Sulfonylurea: Yes/No I-DPP4: Yes/No I-SGLT2: Yes/No ArGLP1: Yes/No Pioglitazone: Yes/No Insulin: Yes/No If insulin is "Yes", which type of dose from the following list will be indicated: Basal (1); Two-dose NPH or premixes (2); Basal-bolus (3); Total daily dose: IU/day	Baseline
Systolic Blood Pressure	mm Hg	At baseline, at 12 weeks and at 24 weeks
Diastolic blood pressure	mm Hg	At baseline, at 12 weeks and at 24 weeks
Heart rate	beats/minute	At baseline, at 12 weeks and at 24 weeks
Weight	kg	At baseline, at 12 weeks and at 24 weeks
Heigth	cm	Baseline
Body Mass Index (BMI)	kg/m2	Baseline
Urinary albumin excretion (UAE)	mg/24 h	At baseline, at 12 weeks and at 24 weeks
Estimated Average Plasma Glucose	mg/dl	At baseline, at 12 weeks and at 24 weeks
Fasting Insulin	µU/ml	At baseline, at 12 weeks and at 24 weeks
Homeostatic Model Assessment for beta-cell function (HOMA-B)		At baseline, at 12 weeks and at 24 weeks
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)	Adimensional	At baseline, at 12 weeks and at 24 weeks
N-terminal pro-B-type natriuretic peptide (NT-proBNP)	pg/ml	At baseline, at 12 weeks and at 24 weeks
Total cholesterol	mg/dl	At baseline, at 12 weeks and at 24 weeks
LDL-C HDL-C, mmol/l	mg/dl	At baseline, at 12 weeks and at 24 weeks
HDL-C	mg/dl	At baseline, at 12 weeks and at 24 weeks
Triglycerides (TG)	mg/dl	At baseline, at 12 weeks and at 24 weeks
Dietetic education	Visit with Dietitian: Yes/No	At baseline, at 12 weeks and at 24 weeks
Cardiovascular events	It will be indicated if cardiovascular events have occurred: Yes/No	At 12 weeks and at 24 weeks

Collaborators and Investigators

• Sponsor: Fundacin Biomedica Galicia Sur

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2021
• Primary Completion (Actual): July 22, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: December 27, 2024
• First Submitted That Met QC Criteria: December 27, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 3, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID Numbers: OILDIABET

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No