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临床试验/NCT02585427
NCT02585427已完成不适用

Effects of Co-ingesting a Low/High GI Meal With Different Fat Saturation on Postprandial Glucose, Insulin, and Triacylglycerol Responses in Healthy Participants

Clinical Nutrition Research Centre, Singapore2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2014年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
25
试验地点
2
主要终点
Insulin response of different treatments

研究概览

简要总结

It is now recognized that diet plays a critical role in the etiology and management of the chronic diseases such as diabetes, obesity and cardiovascular disease. A high consumption of fat, especially saturated fat, is an established risk factor for Cardiovascular Disease.The glycaemic index (GI) is a measurement of the ability of different types of carbohydrate-based foods to raise blood glucose. The interest in low GI food as a weight management tool has been increasing. Different types of carbohydrates differ in their ability to increase postprandial blood glucose and insulin secretion, and may also modulate the effect of different fatty acids. The current study will compare the consumption of low and high GI carbohydrate with different fat saturation on postprandial glucose, insulin, and triacylglycerol responses in healthy participants.

The data generated will have direct applications in public health policy and clinical nutrition management of chronic disease. The outcomes of the study will significantly contribute to the long term national goals of Singapore to manage and to reduce the incidence of chronic disease associated with the metabolic syndrome.

详细描述

This study will be conducted using a randomized, crossover design with six dietary phases: a low GI meal or a high GI meal with saturated fat, monounsaturated fat or polyunsaturated fat. All participants will be randomly allocated to the six test meals, with the order balanced. Fifteen participants aged between 21 and 40 years will be recruited from the general public in Singapore. During the testing session, a maximum of eleven blood samples will be collected by fingerpricks and cannulation. Fingerpricks and cannulation may cause minor discomfort and there may be some slight bruising around the site. Fingerpricks and cannulation will be done by an experienced research nurse or a trained research officer to minimize participant discomfort. If bruising does occur, it should disappear within one day and it should not affect participants' regular daily activity. Participants will be limited to a maximum of two tests per week. In addition, blood collection will be carried out in a sterile designated area and thus the risk of infection will be very low. On rare occasions, participants may feel unwell during or after the testing session. The investigators have several metabolic suites with beds for these individuals to rest on. The research nurse and research officers will monitor the individuals' condition and they will be provided with a ride home if required.

All the study foods will be prepared in a hygienic manner in a purpose-built research kitchen maintained to the highest hygiene standards. The research staff has undergone basic training in food hygiene procedures. Hence, the risk of infective acute gastroenteritis will be minimal.

A number of dietary interventions have aimed to investigate the effect of dietary fat quality on glucose, insulin and lipidemia response. Up to now there have been few studies connect the glycaemic load and fat quality together. The investigators study's results will help public choose fat quality and carbohydrate quality in the diet. Participants will be provided with some snacks at the end of each testing session.

In addition, participants will be provided with their blood glucose, blood insulin, blood lipid profile, blood pressure, and body composition results, with a brief interpretation of these at the conclusion of the study.

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
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

  • Healthy Chinese male subjects aged between 21 and 40 years
  • Do not have major chronic disease such as heart disease, cancer or diabetes mellitus
  • Do not have family history of diabetes
  • Do not have intolerances or allergies to test products(wheat and milk based products)
  • Not taking insulin or drugs known to affect glucose or triglyceride levels and body fat distribution
  • Do not have major medical or surgical event requiring hospitalization within the preceding three months

排除标准

  • 未提供

结局指标

主要结局

Insulin response of different treatments

时间窗: 4 hours postprandial

Insulin concentration will be measured by COBAS Roche analyzer e311

Glucose response of different treatments

时间窗: 4 hours postprandial

The blood glucose will be measured by finger prick and venous blood collection at the same time points

Triglycerides response of different treatments

时间窗: 4 hours postprandial

Triglycerides will be measured by COBAS Roche analyzer e411

次要结局

  • Gastric inhibitory polypeptide response of different treatments(4 hours postprandial)
  • Active Glucagon-like peptide 1 response of different treatments(4 hours postprandial)

研究者

发起方
Clinical Nutrition Research Centre, Singapore
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Melvin Leow

Principal Investigator

Clinical Nutrition Research Centre, Singapore

研究点 (2)

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