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临床试验/NCT02702726
NCT02702726已完成不适用

The Oil, Fats and Oleogel (OFO) Study: Effects of Dietary Fats, Ingested in Two Physical Forms, on Acute Human Energy Balance, Appetitive and Glycemic Responses

Clinical Nutrition Research Centre, Singapore2 个研究点 分布在 1 个国家目标入组 16 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
16
试验地点
2
主要终点
Post-test-meal capillary blood glucose (mmol/L) at 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes

研究概览

简要总结

The aim of this study is to compare the effects of dietary fats, ingested in two physical forms, on acute energy balance, appetitive, and glycemic responses of healthy normal (BMI 18-24.9 kgm-2) or overweight (BMI>25kgm-2) adults.

详细描述

This will be a randomised, crossover study. Randomisation will be performed with an online randomisation software (www.randomizer.org). Participants will be screened (1 screening visit) and attend five test visits conducted in a whole room calorimeter (WRC). During each test visit, participants will arrive at the laboratory after an overnight fast, enter the WRC and rest for 15 minutes in a supine position,have their resting energy expenditure (REE) measured for 30 minutes and consume congee and juice alone(control), or with one of the 4 dietary fats: sunflower oil (SO) or gel (SG) and coconut oil (CO) or gel (CG) (total 5 test visits). Post-meal energy expenditure, fat oxidation, glycemia and appetite (visual analog scales) will be measured continuously for 3 hours in WRC, followed by a meal challenge where participants will eat until sated. Participants will return and repeat the protocol until all fat types and forms are completed.

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

  • Exclusion Criteria:
  • People with major chronic disease such as heart disease, cancer, hypertension or diabetes mellitus
  • People with known food allergies, due to potential traces of allergens found in the commercially available food product used in our study (Knorr's instant congee)
  • People who are claustrophobic
  • Individuals who are taking insulin or drugs known to affect glucose metabolism, appetite, and body fat distribution
  • Have weight change of >5kg in the past 3 months
  • People with a major medical or surgical event requiring hospitalization within the preceding three months
  • People who are on a weight loss regime
  • Individuals with the presence of disease or drugs which influence digestion and absorption of nutrients

排除标准

  • People with major chronic disease such as heart disease, cancer, hypertension or diabetes mellitus
  • People with known food allergies, due to potential traces of allergens found in the commercially available food product used in our study (Knorr's instant congee)
  • People who are claustrophobic
  • Individuals who are taking insulin or drugs known to affect glucose metabolism, appetite, and body fat distribution
  • Have weight change of >5kg in the past 3 months
  • People with a major medical or surgical event requiring hospitalization within the preceding three months
  • People who are on a weight loss regime
  • Individuals with the presence of disease or drugs which influence digestion and absorption of nutrients

研究组 & 干预措施

Congee and juice only

No Intervention

Control breakfast providing 50g carbohydrate

Congee and juice with coconut gel

Active Comparator

Control breakfast, plus 25g coconut oleogel (solid)

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

Congee and juice with coconut oil

Active Comparator

Control breakfast, plus 25g coconut oil (liquid)

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

Congee and juice with sunflower gel

Active Comparator

Control breakfast, plus 25g sunflower oleogel (solid)

干预措施: Congee and juice with sunflower gel (Other)

Congee and juice with sunflower oil

Active Comparator

Control breakfast, plus 25g sunflower oil (liquid)

干预措施: Congee and juice with sunflower oil (Other)

结局指标

主要结局

Post-test-meal capillary blood glucose (mmol/L) at 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes

时间窗: 180 minutes

Capillary blood glucose will be assessed at 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes using a Hemocue system (HemoCue Glucose 201 RT Systems, Helsingborg, Sweden)

180-min postprandial energy expenditure (kJ/min over 180 minutes and total kJ/180-min session) measured by an indirect ventilated-hood calorimeter

时间窗: 180 minutes

Gaseous exchanges obtained from the indirect calorimeter (volume of oxygen consumed and volume of carbon dioxide produced) will be used to calculate energy expenditure using the Weir equation: EE = 3.9 VO2 + 1.1 VCO2 \[Weir, J. B. (1949). "New methods for calculating metabolic rate with special reference to protein metabolism." Journal of Physiology 109(1): 1-9\]

180-min postprandial carbohydrate and fat oxidation (kJ/min over 180 minutes and total kJ and total grams during each session) measured by an indirect ventilated-hood calorimeter

时间窗: 180 minutes

Gaseous exchanges obtained from the indirect calorimeter (volume of oxygen consumed and volume of carbon dioxide produced) will be used to calculate energy expenditure using the Frayn equations: carbohydrate oxidation = 4.55 VCO2 - 3.21 VO2; fat oxidation = 1.67 VO2 - 1.67 VCO2 \[Frayn, K. N. (1983). "Calculation of substrate oxidation rates in vivo from gaseous exchange." Journal of Applied Physiology 55(2): 628-634\]

次要结局

  • Post-test-meal subjective appetite measurements at 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes(180 minutes)
  • Free-living food intake after completion of test session(180 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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