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Bioavailability of N-acylethanolamines: an Ileostomy Study (NAE Study)

NCT05845229 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2023-05-06

No results posted yet for this study

Summary

The endocannabinoids (ECs) and N-acylethanolamines (NAEs) are a group of endogenous lipid mediators which have a pleiotropic activity in the body modulating several biological pathways such as: appetite cues, food intake, blood pressure, inflammation, glycaemia, cognition and immunity. The ECs consist of N-arachidonoylethanolamide (AEA) and 2-arachidonoylglycerol (2-AG). They may have agonist activity on cannabinoid receptors CB1 and CB2 which are located in the central nervous system (CNS) and in peripheral tissues such as in the enteric nervous system (ENS), in the liver and in the adipose tissue. NAEs are known as "endocannabinoid-like" molecules and include oleoylethanolamine (OEA), linoleylethanolamine (LEA), and palmitoyletahanolamine (PEA). Evidence indicates that diet composition may affect fasting and post-prandial plasma ECs, N-acylphosphatidylethanolamines (NAPEs) and NAEs profile due to the content of their precursors, fatty acids and amines.

It is hypothesized that the concentration of NAPEs, NAEs and ECs in a meal could influence the intestinal concentrations of these lipid mediators that could bind the receptors located on the intestinal mucosa and in turn, differently modulate appetite and energy metabolism.

The study is an acute randomized crossover feeding study in ileostmists (n=14), having a breakfast meal low or high in NAPEs, NAEs and ECs. The meals are designed on a database published by our collaborators (University of Naples) and detailed in the research proposal. Concentrations of NAEs and ECs in urine, plasma and ileal fluid, beside the blood glucose, hormonal response, appetite feelings and food intake will be monitored over the experimental days.

Conditions

  • Healthy Nutrition

Interventions

DIETARY_SUPPLEMENT

High-N-acylethanolamine meal

Milk (150 mL), white bread (46 g), jam (10 g), cocoa powder (15 g), whole-grain cereals (30 g).

DIETARY_SUPPLEMENT

Low-N-acylethanolamine meal

Milk (150 mL), whole-grain bread (80 g), jam (10 g), butter (5 g), instant coffee (2 g), dried apples (30 g).

Sponsors & Collaborators

  • Federico II University

    collaborator OTHER

  • University of Ulster

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-16
Primary Completion
2024-06-13
Completion
2024-06-13

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05845229 on ClinicalTrials.gov