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

NCT ID: NCT05845229

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-16
• Study Completion Date: 2024-06-13

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

High-N-acylethanolamines meal

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

Group Type: EXPERIMENTAL

High-N-acylethanolamine meal

Intervention Type: DIETARY_SUPPLEMENT

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

Low-N-acylethanolamines meal

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

Group Type: ACTIVE_COMPARATOR

Low-N-acylethanolamine meal

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

High-N-acylethanolamine meal

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

Intervention Type: 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).

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Federico II University

OTHER

Sponsor Role: collaborator

University of Ulster

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Human Intervention Studies Unit, Ulster University

Coleraine, Co.Londonderry, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Christopher Gill

Role: CONTACT

c.gill@ulster.ac.uk

+44 28 7012 3181

Facility Contacts

Ruth K Price

Role: primary

rk.price@ulster.ac.uk

+442870123878

Julie J Sittlington

Role: backup

jj.sittlington@ulster.ac.uk

+442870124101

Other Identifiers

REC/19/0096

Identifier Type: -

Identifier Source: org_study_id