Healthy NutritionNAENCT05845229
Bioavailability of N-acylethanolamines: an Ileostomy Study (NAE Study)
A study testing High-N-acylethanolamine meal and Low-N-acylethanolamine meal in people with Healthy Nutrition, run by University of Ulster at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Nutrition
- What is being tested?
- High-N-acylethanolamine meal and Low-N-acylethanolamine meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Jan 2023to 13 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Human Intervention Studies Unit, Ulster University
Coleraine, Co.Londonderry, BT52 1SA
Ruth K Price, +442870123878, rk.price@ulster.ac.uk
Julie J Sittlington, +442870124101, jj.sittlington@ulster.ac.uk
About this study
Official title: 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.
- Conditions
- Healthy Nutrition
- Being tested
- High-N-acylethanolamine meal, Low-N-acylethanolamine meal
- Keywords
- Lipid mediators, Nutrient sensing,, Bioavailability,, N-acylethanolamines,, Satiety.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-N-acylethanolamine mealDietary supplement
Milk (150 mL), white bread (46 g), jam (10 g), cocoa powder (15 g), whole-grain cereals (30 g).
Low-N-acylethanolamine mealDietary supplement
Milk (150 mL), whole-grain bread (80 g), jam (10 g), butter (5 g), instant coffee (2 g), dried apples (30 g).
| Study group | Role | What they receive |
|---|---|---|
| High-N-acylethanolamines meal | Experimental | Milk (150 mL), white bread (46 g), jam (10 g), cocoa powder (15 g), whole-grain cereals (30 g). Receives: 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). Receives: Dietary Supplement: Low-N-acylethanolamine meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
N-acylphosphatidylethanolamines (NAPEs) levels in biofluids
Significant changes from baseline in plasma, urines and, Ileal fluids levels of NAPEs by HPLC-MS analysis.
Measured: 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.
Measured: 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.
Measured: Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake
Secondary outcomes (11)
Glycaemia
Measure of glycaemia by using a bedside glucometer.
Measured: Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake
Appetite sensations
Significant changes from baseline in hunger, satiety, fullness and prospective of consumption.
Measured: Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake
Glucagon-like peptide 1 (GLP-1) plasmatic levels
Measure of GLP-1 by using of Luminex kits in plasma samples pre-treated with protease inhibitor cocktail.
Measured: Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake
Glucose-dependent insulinotropic peptide (GIP) plasmatic levels
Measure of GIP by mean of Luminex kits in plasma samples pre-treated with protease inhibitor cocktail.
Measured: Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake
Insulin plasmatic levels
Measure of insulin by mean of Luminex kits in plasma samples pre-treated with protease inhibitor cocktail.
Measured: Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake
Glucagon plasmatic levels.
Measure of glucagon by mean of Luminex kits in plasma samples pre-treated with protease inhibitor cocktail.
Measured: Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake
C-peptide plasmatic levels.
Measure of c-peptide by mean of Luminex kits in plasma samples pre-treated with protease inhibitor cocktail.
Measured: Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake
Ghrelin plasmatic levels.
Measure of ghrelin by mean of Luminex kits in plasma samples pre-treated with protease inhibitor cocktail.
Measured: Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake
Leptin plasmatic levels
Measure of leptin by mean of Luminex kits in plasma samples pre-treated with protease inhibitor cocktail.
Measured: Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake
Energy intake during a buffet meal test
Kilojoules
Measured: 0 hours
Gut microbiota composition
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.
Measured: Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start16 Jan 2023
- Primary completion13 Jun 2024 (estimated)
- Study completion13 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy NutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Collaborators
- Federico II University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05845229
- Sponsor's protocol ID
- REC/19/0096
- Acronym
- NAE
- Status last verified
- May 2023
- First submitted
- 28 Feb 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of N-acylethanolamines: an Ileostomy Study.
- ClinicalTrials.gov ID
- NCT05845229
- Acronym / sponsor ID
- NAE / REC/19/0096
- Conditions
- Healthy Nutrition
- Keywords
- Lipid mediators, Nutrient sensing,, Bioavailability,, N-acylethanolamines,, Satiety.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Collaborators
- Federico II University
- Study start
- 16 Jan 2023 (actual)
- Primary completion
- 13 Jun 2024 (estimated)
- Study completion
- 13 Jun 2024 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-N-acylethanolamines meal | Experimental | Dietary Supplement: High-N-acylethanolamine mealMilk (150 mL), white bread (46 g), jam (10 g), cocoa powder (15 g), whole-grain cereals (30 g). |
| Low-N-acylethanolamines meal | Active comparator | Dietary Supplement: Low-N-acylethanolamine mealMilk (150 mL), whole-grain bread (80 g), jam (10 g), butter (5 g), instant coffee (2 g), dried apples (30 g). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-N-acylethanolamine mealMilk (150 mL), white bread (46 g), jam (10 g), cocoa powder (15 g), whole-grain cereals (30 g). | Dietary supplement | High-N-acylethanolamines meal |
| Low-N-acylethanolamine mealMilk (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-acylethanolamines meal |
Primary outcome
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.
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.
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.
11 secondary outcomes
Glycaemia
Time frame: 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
Glucagon-like peptide 1 (GLP-1) plasmatic levels
Time frame: 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
Insulin plasmatic levels
Time frame: 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
C-peptide plasmatic levels.
Time frame: 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
Leptin plasmatic levels
Time frame: Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake
Energy intake during a buffet meal test
Time frame: 0 hours
Gut microbiota composition
Time frame: Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-N-acylethanolamine meal and Low-N-acylethanolamine meal in people with Healthy Nutrition, run by University of Ulster at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christopher Gill (+44 28 7012 3181, c.gill@ulster.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
N-acylphosphatidylethanolamines (NAPEs) levels in biofluids (time frame: Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.