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

Ulster University

Status: Enrolling

Conditions: Healthy Nutrition

Treatments: Dietary Supplement: High-N-acylethanolamine meal; Dietary Supplement: Low-N-acylethanolamine meal

Study type: Interventional

Funder types: Other

Identifiers

NCT05845229

REC/19/0096

Details and patient eligibility

About

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.

Enrollment: 14 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participant must have previously undergone an ileostomy and be more than 1.5-years post-operative
• Male or female
• Aged 18-70 years at recruitment

Exclusion criteria

• Participants not undergone an ileostomy and/or is less 1.5-years post-operative
• Adults <18 or >70 years at recruitment
• Pregnant/lactating female
• Current smokers
• Lactose intolerant
• Allergic to nuts

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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14 participants in 2 patient groups

High-N-acylethanolamines meal

Experimental group

Description:

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

Treatment:

Dietary Supplement: High-N-acylethanolamine meal

Low-N-acylethanolamines meal

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Low-N-acylethanolamine meal