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

NCT04764786 | Completed

• 1 other identifier: 37/19
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Venous blood drawing samples for the evaluation of gastrointestinal hormones, markers of systemic inflammation and oxidative stress.
2. 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.

Conditions

Type 1 Diabetes

Keywords

type 1 diabetes; postprandial glycemia; polyphenols

Outcome Measures

Primary Outcomes (1)

• the between-group difference in postprandial glycemia changes after the dietary interventions

  Postprandial incremental area (iAUC)

  6 hours

Study Arms (2)

EVOO+POLY

EXPERIMENTAL

Acute test meal

Other: EVOO+POLY

OO-POLY

ACTIVE COMPARATOR

Acute test meal

Other: OO-POLY

Interventions

EVOO+POLY OTHER

a test meal seasoned with extra virgin olive oil rich in polyphenols

EVOO+POLY

OO-POLY OTHER

a test meal seasoned with olive oil poor in polyphenols

OO-POLY

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Federico II University

Napoli, Naples, 80131, Italy

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: February 21, 2021
• Study Start: April 1, 2019
• Primary Completion: November 20, 2019
• Study Completion: November 20, 2020
• Last Updated: February 24, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)