NCT04764786: DOP

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

Completed NA Last updated 24 February 2021

What this trial tests

NA trial testing EVOO+POLY in Type 1 Diabetes in 22 participants. Completed in 20 November 2020.

Timeline

1 April 2019

Primary endpoint
20 November 2019

20 November 2020

Quick facts

Lead sponsor	Federico II University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	triple
Primary purpose	treatment
Enrollment	22
Start date	1 April 2019
Primary completion	20 November 2019
Estimated completion	20 November 2020
Sites	1 location across Italy

Drugs / interventions tested

• EVOO+POLY
• OO-POLY

Conditions studied

• Type 1 Diabetes — all drugs for Type 1 Diabetes →

Sponsor

Federico II University

Who can join

Adults 18 to 65, any sex, with Type 1 Diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Polyphenols, the Healthy Brand of Olive Oil: Insights and Perspectives.
   Finicelli M, Squillaro T, Galderisi U, Peluso G. · · 2021 · cited 36× · PMID 34836087 · DOI 10.3390/nu13113831