Polyphenol Enriched Extra-virgin Olive Oil and Postprandial Glycemia in Type 1 Diabetes (DOP) (DOP)

February 22, 2021 updated by: rivellese angela, Federico II University

Polyphenol Enriched Extra-virgin Olive Oil and Postprandial Glucose Response in Patients With Type 1 Diabetes: Possible Effects and Mechanisms

The aims of this study are to investigate the short term effects of MUFA alone vs. MUFA plus Polyphenols contained in the extra-virgin olive oil (EVOO) on the postprandial glycemic response in patients with type 1 diabetes and to explore the possible mechanisms through which MUFA alone or MUFA plus Polyphenols contained in EVOO could influence postprandial glycaemia.The intervention will be preceded by two-weeks run-in period during which participants will consume an usual olive oil, fill-in a 7-day dietary food record and practice continuous blood glucose monitoring (CGM) in order to optimize basal insulin infusion values and the insulin-to-glycemic load ratio.The study will be conducted according to a randomized cross-over design.

The participants will consume, in random order at a distance of one week from each other, a meal-test seasoned with extra virgin olive oil rich in polyphenols (EVOO + POLY) or a meal-test seasoned with olive oil poor in polyphenols (OO-POLY). Upon fasting and during the 6 hours following the meal, patients will undergo to:

  1. Venous blood drawing samples for the evaluation of gastrointestinal hormones, markers of systemic inflammation and oxidative stress.
  2. Breath test with 13C-octanoic acid, for the study of gastric emptying. During the experimental period the participants will undergo to continuous glucose monitoring wearing sensors 7 days/week.

The results of this study will allow optimizing insulin therapy based on the macronutrient composition of the meal in patients with type 1 diabetes mellitus treated with insulin pump. This will improve glycemic control and quality of life of these patients and reduce the risk of developing chronic diabetes complications.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In a recent study the use of extra virgin olive oil (EVOO) (rich in MUFA) to a high glycemic index meal attenuated the early PGR observed when this meal were consumed with either low-fat or butter (rich in SAFA), while low glycemic index foods determined a blunted early postprandial response and a late rise of blood glucose levels, independently of type and quantity of fat added. Of relevance, the effects on PGR of dietary components known to influence postprandial blood glucose metabolism, such as polyphenols, remain completely unexplored in patients with T1D. Polyphenols are bioactive compounds with high antioxidant power highly present also in EVOO, which could have contributed to the favorable effects on PGR that the investigators observed in patients with T1D.

The aims of this study are to investigate the short term effects of MUFA alone vs. MUFA plus Polyphenols contained in EVOO on the postprandial glycemic response in patients with type 1 diabetes and to explore the possible mechanisms through which MUFA alone or MUFA plus Polyphenols contained in EVOO could influence postprandial glycaemia.

Patients with type 1 diabetes treated with continuous subcutaneous insulin infusion for at least 6 months and HbA1c less than 8.5%, will be recruited at the diabetes care unit of the Federico II University teaching hospital.

The intervention will be preceded by two-weeks run-in period during which participants will consume an usual olive oil, fill-in a 7-day dietary food record and practice continuous blood glucose monitoring (CGM) in order to optimize basal insulin infusion values and the insulin-to-glycemic load ratio.The study will be conducted according to a randomized cross-over design.

The participants will consume, in random order at a distance of one week from each other, a meal-test seasoned with extra virgin olive oil rich in polyphenols (EVOO + POLY), or a meal-test seasoned with olive oil poor in polyphenols (OO- POLY). Upon fasting and during the 6 hours following the meal, patients will undergo to:

  1. Venous blood drawing samples for the evaluation of gastrointestinal hormones, markers of systemic inflammation and oxidative stress.
  2. Breath test with 13C-octanoic acid, for the study of gastric emptying. During the experimental period the participants will undergo to continuous glucose monitoring wearing their sensors 7 days/week.

The meals will be similar in terms of glycemic load and macronutrient composition and will differ in the type of seasoning used.

The test meal will be postponed in case of premeal blood glucose levels outside the 90-150 mg/dl range or a rapid decrease/increase of glucose levels (above 1 mg/dl per min) during the previous 60 min according to CGM measurement, Pre-meal insulin doses, will be calculated based on the individual insulin-to-glycemic load ratio and will be the same on all two occasions.

At the end of the experimental period, data from CGM and insulin pump will be downloaded by dedicated informatics platforms. Participants will use the CGM system integrated with the insulin pump, i.e., the one they are accustomed to.

The primary outcome will be the difference between the postprandial blood glucose change groups following dietary interventions and it will be evaluated by 2-way ANOVA for repeated measurements.

The results of this study will allow optimizing insulin therapy based on the macronutrient composition of the meal in patients with type 1 diabetes mellitus treated with insulin pump. This will improve glycemic control and quality of life of these patients and reduce the risk of developing chronic diabetes complications. These complications involve severe disability for patients and huge costs for the community.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Naples
      • Napoli, Naples, Italy, 80131
        • Federico II University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Treatment with continuous subcutaneous insulin infusion for at least 6 months
  • HbA1c less than 8.5% (69 mmol/mol)

Exclusion Criteria:

  • Pregnancy and breastfeeding
  • Any other chronic or acute disease apart diabetes seriously affecting health status

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EVOO+POLY
Acute test meal
Other: EVOO+POLY
a test meal seasoned with extra virgin olive oil rich in polyphenols
Active Comparator: OO-POLY
Acute test meal
Other: OO-POLY
a test meal seasoned with olive oil poor in polyphenols

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the between-group difference in postprandial glycemia changes after the dietary interventions
Time Frame: 6 hours
Postprandial incremental area (iAUC)
6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Actual)

November 20, 2019

Study Completion (Actual)

November 20, 2020

Study Registration Dates

First Submitted

February 18, 2021

First Submitted That Met QC Criteria

February 18, 2021

First Posted (Actual)

February 21, 2021

Study Record Updates

Last Update Posted (Actual)

February 24, 2021

Last Update Submitted That Met QC Criteria

February 22, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 37/19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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