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

May 2, 2023 updated by: University of Ulster

Bioavailability of N-acylethanolamines: an Ileostomy Study.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: High-N-acylethanolamines meal
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
Milk (150 mL), white bread (46 g), jam (10 g), cocoa powder (15 g), whole-grain cereals (30 g).
Active Comparator: 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).
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
N-acylphosphatidylethanolamines (NAPEs) levels in biofluids
Time Frame: Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake
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
Time Frame: Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake
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
Time Frame: Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Glycaemia
Time Frame: Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake
Measure of glycaemia by using a bedside glucometer.
Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake
Appetite sensations
Time Frame: Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake
Significant changes from baseline in hunger, satiety, fullness and prospective of consumption.
Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake
Glucagon-like peptide 1 (GLP-1) plasmatic levels
Time Frame: Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake
Measure of GLP-1 by using of Luminex kits in plasma samples pre-treated with protease inhibitor cocktail.
Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake
Glucose-dependent insulinotropic peptide (GIP) plasmatic levels
Time Frame: Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake
Measure of GIP by mean of Luminex kits in plasma samples pre-treated with protease inhibitor cocktail.
Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake
Insulin plasmatic levels
Time Frame: Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake
Measure of insulin by mean of Luminex kits in plasma samples pre-treated with protease inhibitor cocktail.
Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake
Glucagon plasmatic levels.
Time Frame: Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake
Measure of glucagon by mean of Luminex kits in plasma samples pre-treated with protease inhibitor cocktail.
Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake
C-peptide plasmatic levels.
Time Frame: Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake
Measure of c-peptide by mean of Luminex kits in plasma samples pre-treated with protease inhibitor cocktail.
Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake
Ghrelin plasmatic levels.
Time Frame: Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake
Measure of ghrelin by mean of Luminex kits in plasma samples pre-treated with protease inhibitor cocktail.
Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake
Leptin plasmatic levels
Time Frame: Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake
Measure of leptin by mean of Luminex kits in plasma samples pre-treated with protease inhibitor cocktail.
Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake
Energy intake during a buffet meal test
Time Frame: 0 hours
Kilojoules
0 hours
Gut microbiota composition
Time Frame: Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake
Microbiota 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.
Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Ulster

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Federico II University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 16, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 13, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 13, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2023

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 5, 2023

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC/19/0096

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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