跳至主要内容
临床试验/NCT05845229
NCT05845229招募中不适用

Bioavailability of N-acylethanolamines: an Ileostomy Study.

University of Ulster2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2023年1月16日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
14
试验地点
2
主要终点
N-acylphosphatidylethanolamines (NAPEs) levels in biofluids

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

N-acylphosphatidylethanolamines (NAPEs) levels in biofluids

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • Glucagon plasmatic levels.(Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake)
  • C-peptide plasmatic levels.(Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake)
  • Ghrelin plasmatic levels.(Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake)
  • Leptin plasmatic levels(Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake)
  • Glycaemia(Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake)
  • Appetite sensations(Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake)
  • Glucagon-like peptide 1 (GLP-1) plasmatic levels(Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake)
  • Glucose-dependent insulinotropic peptide (GIP) plasmatic levels(Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake)
  • Insulin plasmatic levels(Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake)
  • Energy intake during a buffet meal test(0 hours)
  • Gut microbiota composition(Change from baseline at 2, 4, 6 and, 8 hours after breakfast intake)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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