Antidiabetic Effect of Olive Pomace Oil

NCT06723886 | Recruiting

• 2 other identifiers: 20232949253405
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aims at assessing whether consumption of olive pomace oil in the diet may benefit persons with type 2 diabetes mellitus or persons at risk of developing the disease (prediabetic persons). The main questions the study aims to answer are:

• May olive pomace oil prevent a high increase of blood glucose levels when consumed in a meal together with carbohydrates in diabetic/prediabetic patients?
• May olive pomace oil decrease fasting blood glucose levels of diabetic/prediabetic patients after consuming it daily?
• May daily consumption of olive pomace oil improve glucose homeostasis and other alterations like elevated blood lipids or inflammation, which also affect persons with diabetes or prediabetes? Researchers will compare the effect of consuming olive pomace oil to the effects of a comparison oil (high-oleic acid sunflower oil). Participants will: In different days, they will consume white bread alone or the oils (olive pomace oil, high-oleic acid sunflower oil or extra virgin olive oil) spread on white bread and blood will be collected at different times during 2 h. This study to observe the increase of blood glucose after a carbohydrate-rich breakfast will be part of the so-called "postprandial" study, and will be conducted during 3 weeks, during which participants will consume corn oil on a daily basis. Participants will also take part in the "chronic" study, that will last 22 weeks in total. During this study, they will firstly "wash" the effects of the oil they normally consume in their diets by consuming corn oil during 3 weeks. It is during these weeks when they will attend the Human Nutrition Unit (HNU) of ICTAN to carry on the "postprandial" study described in the previous paragraph. After the initial 3 weeks, participants will consume olive pomace oil as the only oil in their diets during 8 weeks, "wash" its effects again by consuming corn oil during 3 weeks and then change to consume the other oil (high-oleic acid sunflower oil) during 8 weeks. During the chronic study, they will visit the clinic once every 4 weeks for checkups and tests. They will refrain from eating other oils or specific fat-rich foods. Participants will also attend our phone calls to ask them what they ate the day before on different weeks during the study, and wear an accelerometer during 1 week to record their physical activity. They will keep a diary of the doses of insulin/metformin used and the blood glucose levels they measured at home.

Conditions

Type 2 Diabetes Mellitus; Prediabetes (Insulin Resistance, Impaired Glucose Tolerance); Prediabetic State; Diabetes; Diabetes Mellitus

Keywords

Olive pomace oil; Diabetes; Prediabetes; Antidiabetic effect; Postprandial study; Chronic intervention; High-oleic acid sunflower oil

Outcome Measures

Primary Outcomes (2)

• Fasting blood glucose

  Change of fasting blood glucose levels at the end of the chronic intervention

  From enrollment to the end of each treatment at 8 weeks

• Postprandial blood glucose response

  Change of postprandial blood glucose levels after consuming white bread with oil in comparison with white bread only. Blood will be collected at 0 h and 1 and 2 h after consuming the bread alone or with the corresponding oil. Olive pomace oil (active comparator) and high-oleic acid sunflower oil (active comparator) will be tested. Only in this postprandial study extra virgin olive oil will also be tested as a positive control (at the beginning of the run-in), along with white bread only (at week 2 of the run-in). Test/comparator oils will be assessed at the beginning of each arm, week 1 of each intervention arm (corresponding to weeks 4 and 14 of the study).

  From enrollment until week 14 of the study

Secondary Outcomes (8)

• Insulin levels

  From enrollment to the end of each treatment at 8 weeks

• Insulin resistance

  From enrollment to the end of each treatment at 8 weeks

• Insulin sensitivity

  From enrollment to the end of each treatment at 8 weeks

• Glycated hemoglobin

  From enrollment to the end of each treatment at 8 weeks

• Beta-cell function

  From enrollment to the end of each treatment at 8 weeks

Other Outcomes (5)

• Blood lipids

  From enrollment to the end of each treatment at 8 weeks

• Inflammatory cytokines

  From enrollment to the end of each treatment at 8 weeks

• Liver function

  From enrollment to the end of each treatment at 8 weeks

Study Arms (2)

Olive pomace oil

EXPERIMENTAL

Consumption of olive pomace oil as the only dietary fat.

Dietary Supplement: Experimental arm: Olive pomace oil

High-sunflower olive oil

ACTIVE COMPARATOR

Consumption of high-oleic acid sunflower oil as the only dietary fat.

Dietary Supplement: High-oleic acid sunflower oil

Interventions

Experimental arm: Olive pomace oil DIETARY_SUPPLEMENT

Participants will consume during 8 weeks either the test oil (olive pomace oil) as the only dietary fat. They will consume 45 g/day of oil, using it in salads, fried foods, as spread on toasts, etc.

Olive pomace oil

High-oleic acid sunflower oil DIETARY_SUPPLEMENT

Participants will consume during 8 weeks either the test active comparator oil (high-oleic acid sunflower oil) as the only dietary fat. They will consume 45 g/day of oil, using it in salads, fried foods, as spread on toasts, etc.

High-sunflower olive oil

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fasting blood glucose between 100-126 mg/dL and/or
• Glycated haemoglobin (HbA1c) between 5.7-6.4% and/or
• Diabetic persons with Fasting blood glucose \>126 mg/dL and/or
• Diabetic persons with Glycated haemoglobin (HbA1c) \> 6.4%

You may not qualify if:

• Kidney or liver diseases
• Gastrointestinal diseases (irritable bowel syndrome, Crohn disease, chronic bowel inflammation)
• Food allergies/intolerances
• Vegetarians/vegans
• Smoking
• Pregnant or lactating women
• On prescription drugs other than for hypertension/thyroid/dyslipidemia/glucose control, or changes in dosage in the last 3 months
• Consumption of vitamins, dietary supplements or nutraceuticals

Sponsors & Collaborators

• Instituto de Ciencia y Tecnología de Alimentos y Nutrición: lead
• ICTAN-CSIC - Madrid - Spain: collaborator

Study Sites (1)

Institute of Food Science, Technology and Nutrition (ICTAN-CSIC)

Madrid, Madrid, 28040, Spain

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Prediabetic State; Insulin Resistance; Glucose Intolerance; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Hyperglycemia

Study Officials

• Laura Bravo, Professor

  ICTAN-CSIC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Bravo, Professor

CONTACT

+34 91 5492300; lbravo@ictan.csic.es

Beatriz Sarria, Dr

CONTACT

+34 91 5492300; beasarria@ictan.csic.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Crossover, controlled, randomized, blind study

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 9, 2024
• Study Start: January 15, 2025
• Primary Completion: March 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: After completion of the study and publication of results
• Access Criteria: Justified request to the principal investigator

Locations

ES (1)