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

Bioavailability of N-acylethanolamines: an Ileostomy Study.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05845229
Acronym
NAE
Enrollment
14
Registered
2023-05-06
Start date
2023-01-16
Completion date
2024-06-13
Last updated
2023-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Nutrition

Keywords

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

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.

Interventions

DIETARY_SUPPLEMENTHigh-N-acylethanolamine meal

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

DIETARY_SUPPLEMENTLow-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).

Sponsors

Federico II University
CollaboratorOTHER
University of Ulster
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
N-acylphosphatidylethanolamines (NAPEs) levels in biofluidsChange from baseline at 2, 4, 6 and, 8 hours after breakfast intakeSignificant changes from baseline in plasma, urines and, Ileal fluids levels of NAPEs by HPLC-MS analysis.
N-acylethanolamines (NAEs) levels in biofluidsChange from baseline at 2, 4, 6 and, 8 hours after breakfast intakeSignificant changes from baseline in plasma, urines and, Ileal fluids levels of NAEs by HPLC-MS analysis.
Endocannabinoids levels in biofluidsChange from baseline at 2, 4, 6 and, 8 hours after breakfast intakeSignificant changes from baseline in plasma, urines and, Ileal fluids levels of ECs by HPLC-MS analysis.

Secondary

MeasureTime frameDescription
Glucose-dependent insulinotropic peptide (GIP) plasmatic levelsChange from baseline at 2, 4, 6 and, 8 hours after breakfast intakeMeasure of GIP by mean of Luminex kits in plasma samples pre-treated with protease inhibitor cocktail.
Insulin plasmatic levelsChange from baseline at 2, 4, 6 and, 8 hours after breakfast intakeMeasure of insulin by mean of Luminex kits in plasma samples pre-treated with protease inhibitor cocktail.
Glucagon plasmatic levels.Change from baseline at 2, 4, 6 and, 8 hours after breakfast intakeMeasure of glucagon by mean of Luminex kits in plasma samples pre-treated with protease inhibitor cocktail.
C-peptide plasmatic levels.Change from baseline at 2, 4, 6 and, 8 hours after breakfast intakeMeasure of c-peptide by mean of Luminex kits in plasma samples pre-treated with protease inhibitor cocktail.
GlycaemiaChange from baseline at 2, 4, 6 and, 8 hours after breakfast intakeMeasure of glycaemia by using a bedside glucometer.
Leptin plasmatic levelsChange from baseline at 2, 4, 6 and, 8 hours after breakfast intakeMeasure of leptin by mean of Luminex kits in plasma samples pre-treated with protease inhibitor cocktail.
Energy intake during a buffet meal test0 hoursKilojoules
Gut microbiota compositionChange from baseline at 2, 4, 6 and, 8 hours after breakfast intakeMicrobiota composition will be determined by high throughput sequencing of the 16S ribosomal ribonucleic acid (rRNA) gene. The massive number of sequences obtained will be analyzed by using state of the art bioinformatics tools and the presence and relative abundance of the microbial species occurring in each sample will be determined.
Ghrelin plasmatic levels.Change from baseline at 2, 4, 6 and, 8 hours after breakfast intakeMeasure of ghrelin by mean of Luminex kits in plasma samples pre-treated with protease inhibitor cocktail.
Appetite sensationsChange from baseline at 2, 4, 6 and, 8 hours after breakfast intakeSignificant changes from baseline in hunger, satiety, fullness and prospective of consumption.
Glucagon-like peptide 1 (GLP-1) plasmatic levelsChange from baseline at 2, 4, 6 and, 8 hours after breakfast intakeMeasure of GLP-1 by using of Luminex kits in plasma samples pre-treated with protease inhibitor cocktail.

Countries

United Kingdom

Contacts

Primary ContactChristopher Gill
c.gill@ulster.ac.uk+44 28 7012 3181

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026