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

NCT ID: NCT06757751

Last Updated: 2025-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-30
• Study Completion Date: 2022-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.).

Group Type: EXPERIMENTAL

EVOO diet supplement

Intervention Type: 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).

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.).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundacin Biomedica Galicia Sur

OTHER

Sponsor Role: lead

Responsible Party

Beatriz Cancho Grande

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beatriz Cancho Grande

Ourense, , Spain

Countries

Spain

Other Identifiers

OILDIABET

Identifier Type: -

Identifier Source: org_study_id