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临床试验/NCT06640335
NCT06640335进行中(未招募)不适用

The Effects of Vegetable Preloading on Postprandial Glycemia, Insulinaemia and Gastric Emptying in Healthy Adults: A Randomized Cross-over Trial

Singapore Institute of Food and Biotechnology Innovation2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
24
试验地点
2
主要终点
Postprandial blood glucose

研究概览

简要总结

The objective of this study is to investigate the importance of leavy vegetable preloading on the postprandial glycaemic and insulinemic response in human subjects when consumed a specific amount of digestible carbohydrate from Russet Burbank potatoes source.

详细描述

The proposed research is part of strategies to manipulate postprandial glycemia and generate weight-control-related benefits, such as promoting satiation. Literature has shown pre-loading caloric nutrients can change postprandial glycemia, but the mechanism is unclear. The investigators hypothesize that a small number of nutrients released in the small intestine can initiate physiological changes and develop feedback control to delay gastric emptying, leading to the delay in digestion of glycemic carbohydrates and the consequent moderate glycemic responses. The investigators propose to use potatoes as the testing glycemic carbohydrates, and the pre-load foods are green vegetables. The investigators will be testing the optimal preload time to achieve the highest control of glycemic response as well as the strongest effect in satiety induction. In addition, green vegetables will be consumed with or without a preload fat enhancer (canola oil) to investigate the mechanism behind significant preload compositions. Healthy adults will be instructed to eat the leafy vegetables first (with or without canola oil), followed by the potato foods (i.e., mashed potatoes). The measurement is the gastric emptying time, blood sugar concentration, insulin, and an appetite-related gut hormone GLP-1. In order to monitor gastric emptying using a non-invasive approach, a popular breath test used in children and a hydrogen breath test will be used to present the change of gastric emptying and the level of gut fermentation.

Results will demonstrate the mechanism of the impact of pre-loading nutrients on the digestion of glycemic carbohydrates. The goal is to eliminate the negative influence of glycemic carbohydrate consumption. Instead, to generate health benefits from dietary carbohydrates.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

年龄范围
21 Years 至 40 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Normal body mass index (18.5 kg/m2 to 24.9 kg/m2), weight >/= 45 kg
  • Normal blood pressure </=120/80 mmH
  • Fasting blood glucose of <5.6 mmol/l
  • Able to provide written informed consent before participating in the study.
  • Able to communicate adequately to comply with the requirements of the entire study, i.e., able to eat test meal and provide breath samples.

排除标准

  • Individuals with any metabolic diseases (such as diabetes, hypertension etc).
  • Individuals with known glucose-6-phosphate dehydrogenase deficiency (G6PD deficiency).
  • Individuals with medical conditions and/or taking medications known to affect glycaemia (glucocorticoids, thyroid hormones, thiazide diuretics).
  • Individuals who take any prescribed medication or dietary supplements which may interfere with the study measurements.
  • Individuals who have any major organ dysfunction (eg. cardiovascular, respiratory, hepatic, renal, gastrointestinal) that may influence taste, olfaction, appetite, digestion, metabolism, absorption or elimination of test foods, nutraceutical or drug.
  • Individuals with history of malabsorption due to mucosal disease, pancreatic disease, or other causes.
  • Individuals with history of gastrointestinal disease or surgery (excludes appendectomy, hernia repair and anorectal disorders).
  • Individuals who are allergic/intolerant to any of the test foods to be administered, or any of the following common food and ingredients: eggs, fish, milk, peanuts, tree nuts, shellfish, soya, wheat, gluten, cereal, fruits, dairy products, meat, vegetable, sugar and sweetener, natural food colourings or flavourings, sulphites etc.
  • People who intentionally restrict food intake.
  • People who consume excessive 13C rich products such as corn, sugar beet and pineapple.
  • Individuals who partake in sports at the competitive and/or endurance levels
  • Individuals who have any known chronic infection or known to suffer from or have previously suffered from or is a carrier of Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV).
  • Individuals who is a study team member or an immediate family of any study team member.
  • Individuals who consume Excessive alcohol: consuming >/= 6 alcoholic drinks per week.

结局指标

主要结局

Postprandial blood glucose

时间窗: up to 3 hour (180 minutes) after test meal consumption

Blood samples are taken at baseline, 15, 30, 45, 60, 90, 120, 150 and 180 minutes. Glucose levels are tested in the serum using cobas c311 analyzer.

Postprandial blood Insulin

时间窗: up to 3 hour (180 minutes) after test meal consumption

Blood samples are taken at baseline, 15, 30, 45, 60, 90, 120, 150 and 180 minutes. Insulin levels are tested in the serum using cobas e411 Immunoanalyzer.

Postprandial Glucagon Like Peptide -1 Total (GLP-1)

时间窗: up to 3 hour (180 minutes) after test meal consumption

Blood samples are taken at baseline, 15, 30, 45, 60, 90, 120, 150 and 180 minutes. GLP-1 levels are tested in the plasma using GLP-1 Total ELISA kit (EZGLP1T-36K)

次要结局

未报告次要终点

研究者

发起方
Singapore Institute of Food and Biotechnology Innovation
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Amy Lin, PhD

Senior Principal Scientist I

Singapore Institute of Food and Biotechnology Innovation

研究点 (2)

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