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

Not Applicable

Completed

• Conditions: Obesity and pre-diabetes; Nutritional, Metabolic, Endocrine; Obesity Pre-diabetes

• Registration Number: ISRCTN17232860
• Lead Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Brief Summary

2023 Preprint results in https://doi.org/10.1101/2023.03.24.23287704 (added 31/03/2023) 2023 Results article in https://doi.org/10.1016/j.clnu.2023.06.027 (added 04/07/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-06-13
• Study Start: 2020-02-10
• Last Update Posted: 18 July 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 91

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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