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

Fundacin Biomedica Galicia Sur

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Dietary Supplement: EVOO diet supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT06757751

OILDIABET

Details and patient eligibility

About

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.

Enrollment: 116 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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116 participants in 2 patient groups

Intervention arm

Experimental group

Description:

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.).

Treatment:

Dietary Supplement: EVOO diet supplement

Control arm

No Intervention group

Description:

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.).