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

NCT06757751 | Completed

• 1 other identifier: OILDIABET
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (27)

• Age

  Baseline

• Sex at birth

  Baseline

• Cardiovascular Risk Factors

  Baseline

• Hepatic dysfunction

  Baseline

• Previous heart disease

  Baseline

Study Arms (2)

Intervention arm

EXPERIMENTAL

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

Control arm

NO INTERVENTION

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.).

Interventions

EVOO diet supplement DIETARY_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).

Intervention arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacin Biomedica Galicia Sur: lead

Study Sites (1)

Beatriz Cancho Grande

Ourense, 32004, Spain

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

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: PhD

Study Record Dates

• First Submitted: December 27, 2024
• First Posted: January 3, 2025
• Study Start: April 30, 2021
• Primary Completion: July 22, 2022
• Study Completion: September 30, 2022
• Last Updated: January 6, 2025

Record last verified: 2025-01

Locations

ES (1)