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UnknownNCT05845229

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

Bioavailability of N-acylethanolamines: an Ileostomy Study.

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
14 (estimated)
Sponsor
University of Ulster · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTHigh-N-acylethanolamine mealMilk (150 mL), white bread (46 g), jam (10 g), cocoa powder (15 g), whole-grain cereals (30 g).
DIETARY_SUPPLEMENTLow-N-acylethanolamine mealMilk (150 mL), whole-grain bread (80 g), jam (10 g), butter (5 g), instant coffee (2 g), dried apples (30 g).

Timeline

Start date
2023-01-16
Primary completion
2024-06-13
Completion
2024-06-13
First posted
2023-05-06
Last updated
2023-05-06

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT05845229. Inclusion in this directory is not an endorsement.