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临床试验/NCT02969057
NCT02969057已完成不适用

Effects of Liquid Oil vs Oleogel Co-ingested With a Carbohydrate-rich Meal on Human Blood Triglycerides, Glucose, Insulin and Appetite.

Clinical Nutrition Research Centre, Singapore1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2016年10月1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
18
试验地点
1
主要终点
Change in postprandial serum glucose over 360 minutes period

研究概览

简要总结

The objective of the present study is to compare the effects of liquid or solid state of food on glycaemia, lipaemia and insulinaemia. 25 participants aged between 21 and 45 years will be recruited from the general public in Singapore. 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 one test 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. We 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. Participants will be provided with some snacks at the end of each testing session. They will also be reimbursed to compensate for their time and costs associated with travel and parking at the completion of the study. In addition, participants will be provided with their blood glucose, blood pressure, and body composition results, with a brief interpretation of these at the conclusion of the study.

详细描述

Design: This will be a randomised, crossover study with five sessions in total. 1.) Instant rice porridge with orange juice, 2.) Instant rice porridge with palm oil, with orange juice 3.) Instant rice porridge with palm oleogel, with orange juice 4.) Instant rice porridge with liquid rice bran oil, with orange juice 5.) Instant rice porridge with rice bran oleogel, with orange juice

Study population: Healthy Chinese males (BMI 18-25 kgm-2) with body weight >/=45 kg, aged 21-45 years with normal fasting blood glucose (<6.0 mM), will be recruited from the general public in Singapore. The exclusion criteria are people with major chronic disease such as heart disease, cancer or diabetes mellitus, glucose-6-phosphate dehydrogenase (G-6-PD) deficiency, glucose intolerance, intolerances or allergies to test products, as well as individuals who are taking insulin or drugs known to affect glucose metabolism. 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, people who are on any therapeutic diet/ drug therapy and smokers will be excluded.

Screening visit: During the screening session, participants will receive an informed consent form and given ample time to go through it and rectify any queries they have. If they decide to take part in the study, they will be asked to sign the informed consent form. They will then be asked to complete a screening questionnaire, baseline measurements including anthropometric measurements, blood pressure, and physical activity level will be collected from each participant in order to determine their eligibility. Body weight and body composition will be measured using bioelectrical impedance analysis. Height will be measured using a stadiometer in order to calculate participants' BMI. Blood pressure will also be measured. All measurements will be taken in duplicate. Participants will then be scheduled for the 5 subsequent test visits. The screening visit will take approximately 1 hour.

Screening questionnaire: The screening questionnaire will include contact information, demographic, general health details, and physical activity level. This information will be used to determine whether the participant is eligible for the study, as well as to check for any possible confounders that may influence the study outcomes. Physical activity level will be measured using a previously validated international physical activity questionnaire.

Meal composition: The test meal will consist of cooking oil (palm oil or rice bran oil in either liquid or gelled form made with ethylcellulose), orange juice and commercially available instant porridge.

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 45 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Healthy Chinese male
  • Age between 21 and 45 years
  • BMI 18-25 kg/m2
  • Body weight >/=45 kg
  • Normal Blood Pressure (=140/90 mmHg)
  • Normal Fasting Blood Glucose (<6.0 mM)

排除标准

  • People who take part in sports at competitive/endurance levels•
  • People with major chronic disease such as heart disease, cancer or diabetes mellitus
  • People who are glucose-6-phosphate dehydrogenase (G-6-PD) deficiency
  • People who have intolerances or allergies to test products
  • Individuals who are taking 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 three months
  • Individuals with the presence of disease or drugs which influence digestion and absorption of nutrients
  • People who are on any therapeutic diet/ drug therapy

研究组 & 干预措施

Breakfast only

No Intervention

Control breakfast providing 50g carbohydrate

Breakfast with rice bran oil gel

Active Comparator

Control breakfast, plus 25g rice bran oil gel (solid)

干预措施: Breakfast with rice bran oil gel (Other)

Breakfast with rice bran oil

Active Comparator

Control breakfast, plus 25g rice bran oil (liquid)

干预措施: Breakfast with rice bran oil (Other)

Breakfast with palm oil gel

Active Comparator

Control breakfast, plus 25g palm oil gel (solid)

干预措施: Breakfast with palm oil gel (Other)

Breakfast with palm oil

Active Comparator

Control breakfast, plus 25g palm oil (liquid)

干预措施: Breakfast with palm oil (Other)

结局指标

主要结局

Change in postprandial serum glucose 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, 30, 45, 60, 90, 120, 150 and 180, 210, 240, 270, 300, 330 and 360 minutes

Change in postprandial blood glucose over 180 minutes period

时间窗: 180 minutes

Blood obtained through fingerprick, analysed using Hemocue analyser.

Change in postprandial serum 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, 30, 45, 60, 90, 120, 150 and 180, 210, 240, 270, 300, 330 and 360 minutes

次要结局

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

Principle Investigator

Clinical Nutrition Research Centre, Singapore

研究点 (1)

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