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

NCT05845229 | Unknown

• 1 other identifier: REC/19/0096
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Keywords

Lipid mediators; Nutrient sensing,; Bioavailability,; N-acylethanolamines,; Satiety.

Outcome Measures

Primary Outcomes (3)

• N-acylphosphatidylethanolamines (NAPEs) levels in biofluids

  Significant changes from baseline in plasma, urines and, Ileal fluids levels of NAPEs by HPLC-MS analysis.

  Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake

• N-acylethanolamines (NAEs) levels in biofluids

  Significant changes from baseline in plasma, urines and, Ileal fluids levels of NAEs by HPLC-MS analysis.

  Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake

• Endocannabinoids levels in biofluids

  Significant changes from baseline in plasma, urines and, Ileal fluids levels of ECs by HPLC-MS analysis.

  Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake

Secondary Outcomes (11)

• Glycaemia

  Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake

• Appetite sensations

  Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake

• Glucagon-like peptide 1 (GLP-1) plasmatic levels

  Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake

• Glucose-dependent insulinotropic peptide (GIP) plasmatic levels

  Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake

• Insulin plasmatic levels

  Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake

Study Arms (2)

High-N-acylethanolamines meal

EXPERIMENTAL

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

Dietary Supplement: High-N-acylethanolamine meal

Low-N-acylethanolamines meal

ACTIVE COMPARATOR

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

Dietary Supplement: Low-N-acylethanolamine meal

Interventions

High-N-acylethanolamine meal DIETARY_SUPPLEMENT

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

High-N-acylethanolamines meal

Low-N-acylethanolamine meal DIETARY_SUPPLEMENT

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

Low-N-acylethanolamines meal

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Ulster: lead
• Federico II University: collaborator

Study Sites (1)

Human Intervention Studies Unit, Ulster University

Coleraine, Co.Londonderry, BT52 1SA, United Kingdom

RECRUITING

Central Study Contacts

Christopher Gill

CONTACT

+44 28 7012 3181; c.gill@ulster.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: May 6, 2023
• Study Start: January 16, 2023
• Primary Completion: June 13, 2024
• Study Completion: June 13, 2024
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)