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临床试验/NCT02924896
NCT02924896已完成不适用

The Chemical Structure of a Lipid Determines Its Effect on Blood Lipid Profile and Appetite Regulation

Imperial College London2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2016年9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
入组人数
12
试验地点
2
主要终点
Change From Baseline in Appetite Hormones PYY

研究概览

简要总结

Aims: To investigate whether acute ingestions of palm oil will have an effect on appetite regulation

详细描述

Design: A randomized, single blind, cross over design including 4 single study visits separated by a week. Visit 1 is an acclimatization visit followed by visit 2,3, and 4 where different types of fat will be given.

Population: 12 healthy males and females aged between 18 and 60 years with body mass index (BMI) between 18.5- 29.9kg/m2 and normal fasting plasma glucose and no evidence of insulin resistance will be recruited. No-pre existing morbidity including cardiac, hepatic or renal disease, history of diabetes, hypertension or hyperlipidaemia.

Treatment: Acclimatization visit: At visit 1, all participants will be given a milkshake like drink containing fat, protein and carbohydrate. A cannula will be inserted for the duration of the study day but no blood will be taken. Studies show than during the first visit stress response can affect the metabolic response to the study drink resulting in inaccurate results.

Study visit 2,3,4: following the acclimatization visit, participants will attend 3 more study visits separated by a week to test the metabolic response to the following fats: palm olein, interesterified palm olein and soybean oil in random order. Participants will be asked to complete a visual analogue scale questionnaire about their appetite at each time point. Fasting and postprandial plasma glucose, insulin, appetite hormones and lipids will be measured.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy and overweight male and female volunteers of all ethnicities (body mass index (BMI) of 18.5-29.9 kg/m2)
  • Age between 18-60 years (inclusive)

排除标准

  • Abnormal liver function test (elevated alanine aminotransferase and aspartate transaminase)/ abnormal kidney function test (elevated plasma creatinine)
  • History of type 2 diabetes mellitus, cancer, stomach ulcers, drug abuse or alcoholism, gastrointestinal disorders like Crohn's disease
  • On lipid/blood pressure- lowering medication/supplements
  • Blood pressure>140/90 mm Hg
  • Fasting total cholesterol > 6.2 mmol/L
  • Fasting triacylglyceride > 2.0 mmol/L
  • Subject must not be allergic to intervention
  • Pregnancy and breastfeeding (pregnancy test will be undertaken at the screening visit)
  • Subjects taking nutritional supplements or on any weight-loss programs
  • Subjects who gained or lost ≥ 3kg weight in the past three months
  • Subjects with history of hypo- and hyperthyroidism
  • Subjects who are anaemic and those who donated blood within three months of the study

研究组 & 干预措施

Arm 3

Other

Interesterified Palm Olein

干预措施: Soybean oil (Dietary Supplement)

Arm 1

Other

Palm Olein

干预措施: Soybean oil (Dietary Supplement)

Arm 1

Other

Palm Olein

干预措施: Palm olein (Dietary Supplement)

Arm 1

Other

Palm Olein

干预措施: Interesterified palm olein (Dietary Supplement)

Arm 2

Other

Soybean Oil

干预措施: Palm olein (Dietary Supplement)

Arm 2

Other

Soybean Oil

干预措施: Interesterified palm olein (Dietary Supplement)

Arm 3

Other

Interesterified Palm Olein

干预措施: Palm olein (Dietary Supplement)

Arm 3

Other

Interesterified Palm Olein

干预措施: Interesterified palm olein (Dietary Supplement)

Arm 2

Other

Soybean Oil

干预措施: Soybean oil (Dietary Supplement)

结局指标

主要结局

Change From Baseline in Appetite Hormones PYY

时间窗: 480 minutes

blood samples will be collected at specific time points presented as minutes from consumption of mixed meal. time (minutes)=-15, -5, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 420, 480.

次要结局

  • Change From Baseline in Glucose,(480 min)
  • Change From Baseline in Appetite Hormones GLP_1(ime (minutes)=-15, -5, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 420, 480. Time Frame: 480 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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