Effect of extra virgin olive oil versus refined olive oil in alleviating obesity-induced inflammation in obese people with pre-diabetes

Randomized double-blind cross-over interventional trial to assess the beneficial effects of extra-virgin olive oil versus refined olive oil in metainflammation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17232860

Enrollment

130

Registered

2020-02-10

Start date

2018-03-08

Completion date

Unknown

Last updated

2023-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity and pre-diabetes Nutritional, Metabolic, Endocrine Obesity Pre-diabetes

Interventions

One-month consumption of one type of olive oil (extra-virgin olive oil or refined olive oil) followed by a wash period of 15 days and a second one-month consumption of the second olive oil (refined ol

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adult (40 - 65 years old) 2. Obese: BMI 30 - 40 kg/m² 3. Glycated hemoglobin (HbA1c): 5.7 - 6.4 4. Signed informed consent

Exclusion criteria

Exclusion criteria: 1. Previous diagnosis of diabetes mellitus 2. Pregnant women 3. Diagnosis of some type of neoplasia 4. Inflammatory diseases in progress (Crohn's disease, ulcerative colitis, arthritis) and/or anti-inflammatory treatments 5. Women in hormone replacement therapy 6. Eat regularly more than 3 meals/week away from home (lunch or dinner, unless it is homemade food prepared with the provided oil)

Design outcomes

Primary

Measure	Time frame
Inflammatory markers measured from serum/plasma samples by multiplex assay (IL-6, IL-1B, TNF-a, Leptin, adiponectin, CXCL-1, IFN-g, IL12p40, IL-4, IL-10, IL-13, IL-RA, hs-CRP) before and after each treatment	—

Secondary

Measure	Time frame
1. Body weight (kg) measured before and after each treatment Measured from serum/plasma samples by multiplex assay before and after each treatment: 2. Metabolic status (fasting glucose, insulinemia, HOMA-IR, HOMA-B, HbA1C, lipid profile) 3. Standard biochemical analysis (Urea, uric acid, albumin, Fe2+, ferritin, bilirrubin, FA, Vit D, hemogram) 4. Oxidative status (LOOH, AOPP, TAS, Total thiol, Glutatione reductase) 5. Lipidomic profile by DOSY-NMR 6. Microbiota profile	—

Measure

Time frame

1. Body weight (kg) measured before and after each treatment Measured from serum/plasma samples by multiplex assay before and after each treatment: 2. Metabolic status (fasting glucose, insulinemia, HOMA-IR, HOMA-B, HbA1C, lipid profile) 3. Standard biochemical analysis (Urea, uric acid, albumin, Fe2+, ferritin, bilirrubin, FA, Vit D, hemogram) 4. Oxidative status (LOOH, AOPP, TAS, Total thiol, Glutatione reductase) 5. Lipidomic profile by DOSY-NMR 6. Microbiota profile

—

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026