Bioavailability of N-acylethanolamines: an Ileostomy Study (NAE Study)
- Conditions
- Healthy Nutrition
- Interventions
- Dietary Supplement: Low-N-acylethanolamine mealDietary Supplement: High-N-acylethanolamine meal
- Registration Number
- NCT05845229
- Lead Sponsor
- University of Ulster
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 14
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Low-N-acylethanolamines meal 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). High-N-acylethanolamines meal High-N-acylethanolamine meal Milk (150 mL), white bread (46 g), jam (10 g), cocoa powder (15 g), whole-grain cereals (30 g).
- Primary Outcome Measures
Name Time Method N-acylphosphatidylethanolamines (NAPEs) levels in biofluids 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 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 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.
- Secondary Outcome Measures
Name Time Method Glucagon plasmatic levels. 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.
C-peptide plasmatic levels. 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.
Ghrelin plasmatic levels. 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.
Leptin plasmatic levels 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.
Glycaemia Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake Measure of glycaemia by using a bedside glucometer.
Appetite sensations 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.
Glucagon-like peptide 1 (GLP-1) plasmatic levels 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.
Glucose-dependent insulinotropic peptide (GIP) plasmatic levels 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.
Insulin plasmatic levels 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.
Energy intake during a buffet meal test 0 hours Kilojoules
Gut microbiota composition 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.
Trial Locations
- Locations (1)
Human Intervention Studies Unit, Ulster University
🇬🇧Coleraine, Co.Londonderry, United Kingdom