Clinical trial NCT05845229: Bioavailability of N-acylethanolamines: an Ileostomy Study (NAE Study)
Official title: Bioavailability of N-acylethanolamines: an Ileostomy Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Nutrition
Keywords: Lipid mediators
Nutrient sensing,
Bioavailability,
N-acylethanolamines,
Satiety.
Lead sponsor: University of Ulster
Sponsor class: OTHER
Collaborators: name: Federico II University
First posted: 2023-05-06
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: N-acylphosphatidylethanolamines (NAPEs) levels in biofluids
timeFrame: Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake
measure: N-acylethanolamines (NAEs) levels in biofluids
timeFrame: Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake
measure: Endocannabinoids levels in biofluids
timeFrame: Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake
Secondary outcomes:
measure: Glycaemia
timeFrame: Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake
measure: Appetite sensations
timeFrame: Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake
measure: Glucagon-like peptide 1 (GLP-1) plasmatic levels
timeFrame: Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake
measure: Glucose-dependent insulinotropic peptide (GIP) plasmatic levels
timeFrame: Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake
measure: Insulin plasmatic levels
timeFrame: Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake
measure: Glucagon plasmatic levels.
timeFrame: Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake
measure: C-peptide plasmatic levels.
timeFrame: Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake
measure: Ghrelin plasmatic levels.
timeFrame: Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake
measure: Leptin plasmatic levels
timeFrame: Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake
measure: Energy intake during a buffet meal test
timeFrame: 0 hours
measure: Gut microbiota composition
timeFrame: Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake
Other outcomes:
Locations:
city: Coleraine
country: United Kingdom
facility: Human Intervention Studies Unit, Ulster University
state: Co.Londonderry
Study officials:
References: