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临床试验/NCT02875275
NCT02875275已完成不适用

Liquid or Solid State of Food on Glycaemia, Lipaemia and Insulinaemia

Clinical Nutrition Research Centre, Singapore2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2016年1月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
23
试验地点
2
主要终点
Change in postprandial blood glucose over 180 minutes period

研究概览

简要总结

This study examines the metabolic effects of 3 possible test meals (Oleogel) and/or 3 possible test meals (Grass Jelly). The participants will have the option to voluntarily choose which study part(s) to participate. This study will be evaluated on 40 healthy Chinese male subjects from the general public over a period of one year.

详细描述

This study examines the metabolic effects of 3 possible test meals (Oleogel) and/or 3 possible test meals (Grass Jelly). The participants will have the option to voluntarily choose which study part(s) to participate. This study will be evaluated on 40 healthy Chinese male subjects from the general public over a period of one year.

Treatments will be randomized to receive 3 different test meals (Oleogel) and/or 3 different test meals. Randomization means assigning the participants to the test meals by chance, like tossing a coin or rolling a dice.

If the participants take part in this study, the participants will be required to come on 3 non-consecutive days and/or 5 non-consecutive days to evaluate the 3 different test meals (Oleogel) and/or 3 different test meal (Grass jelly) respectively, in random order with a minimum of 1 week between the test sessions. For each session, the participants are required to come between 8:00-9:00am, with each session lasting approximately 3.5 hours to 6.5 hours. The participants would have to come following a 10-12 hour overnight fast. An indwelling catheter will be inserted into a vein in the participants' forearm for the remainder of the test session. The investigators will then take a blood sample from the cannula to measure baseline values. The investigators will also take the participant's capillary blood via finger prick to measure blood glucose concentration. After obtaining the baseline blood samples, the investigator will give the participants the test meal to eat within 10 minutes and fill up a 'liking' questionnaire. Following the meal the investigators will take further blood samples (from the cannula and finger pricks) for the next 10, 20, 30, 45, 60, 90, 120, 150, 180, (treatment 4, 5, 6), 210, 240, 270, 300, 330, 360 minutes (Treatment 1, 2, 3).

The amount of blood that will be collected at every time point will be about 5µL droplet from fingerprick and approximately 5mL of blood from cannulation, the accumulative amount per test session will approximately 50 to 80 ml, and the accumulative amount for the entire study duration will be approximately 240 mL of blood by cannula and finger pricks (Part A) and 150 ml (Part B). The investigators will also ask the participants to answer a questionnaire about measurement of hunger and fullness at the same times the blood samples are taken. The appetite-rating questionnaire consists of 100mm continuous lines anchored at each end with opposing statements for a question asked. The specific questions asked will be: 'How hungry do you feel?', 'How full do you feel?', How strong is your desire to eat?', 'How much food do you think you can eat?' and 'Do you have any preoccupation with thoughts of food right now?'. Using a pen, you would have to make a mark on the line corresponding to how you feel.

In addition to the VAS scales, the current trial will collect information on the prospective portion that participants would like to consume for a range of different foods at different time points; at every 30 minutes interval from baseline till the end of each test session. This computer based task presents a range of foods to participants and asks "how much of this food would you like to consume right now?", allowing the participants to move between a series of different portions of each food and select the one that the participants would like to consume at that time based on the participants' feeling of hunger, fullness and desire to eat. The foods will be deliberately chosen to represent common Singaporean meals, desserts and snack foods that are regularly eaten to relieve hunger in different situations and the range of portions available is the same across all foods (20-1200 kcals in 20 kcal steps).

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

  • 21-40 years
  • Body Mass Index 18-25 kg/m2
  • Body weight more than or equals to 45kg
  • Normal blood pressure (≤140/90) and normal fasting blood glucose (<6.0 mM)

排除标准

  • Have major chronic disease such as heart disease, cancer or diabetes mellitus, intolerances or allergies to test products
  • User of insulin or drugs known to affect glucose metabolism and body fat distribution
  • People with a major medical or surgical event requiring hospitalization within the preceding 3 months
  • Individuals with the presence of disease or drugs which influence digestion and absorption of nutrients
  • Current smokers
  • People who are on any therapeutic diet/drug

研究组 & 干预措施

Glucose Solution only

No Intervention

Control drink containing 50 g carbohydrate

Glucose with grass jelly solution

Active Comparator

Control drink plus 3.12 g grass jelly powder

干预措施: Glucose with grass jelly solution (Other)

Glucose with grass jelly (solid)

Active Comparator

Control drink plus 3.12 g grass jelly powder in solid form

干预措施: Glucose with grass jelly (solid) (Other)

Porridge and juice only

No Intervention

Control breakfast containing 50 g carbohydrate.

Porridge and juice with coconut oil

Active Comparator

Control breakfast, plus 25g coconut oil

干预措施: Porridge and juice with coconut oil (Other)

Porridge and juice with coconut oil gel

Active Comparator

Control breakfast, plus 25g coconut oil gel

干预措施: Porridge and juice with coconut oil gel (Other)

结局指标

主要结局

Change in postprandial blood glucose over 180 minutes period

时间窗: 180 minutes

Blood obtained through fingerprick, analysed using Hemocue analyser. Capillary blood glucose will be assessed at 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes.

Change in postprandial plasma triglyceride over 360 minutes period

时间窗: 360 minutes

Venous blood obtain through cannula, analysed using Cobas analyser. Venous plasma triglyceride will be assessed at 0, 10, 20, 45, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360 minutes.

次要结局

  • Change in postprandial plasma insulin over 360 minutes period(360 minutes)

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

JeyaKumar Henry

Principal Investigator

Clinical Nutrition Research Centre, Singapore

研究点 (2)

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