The Chemical Structure of a Lipid Determines Its Effect on Blood Lipid Profile and Appetite Regulation
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
- 是
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
Interesterified Palm Olein
干预措施: Soybean oil (Dietary Supplement)
Arm 1
Palm Olein
干预措施: Soybean oil (Dietary Supplement)
Arm 1
Palm Olein
干预措施: Palm olein (Dietary Supplement)
Arm 1
Palm Olein
干预措施: Interesterified palm olein (Dietary Supplement)
Arm 2
Soybean Oil
干预措施: Palm olein (Dietary Supplement)
Arm 2
Soybean Oil
干预措施: Interesterified palm olein (Dietary Supplement)
Arm 3
Interesterified Palm Olein
干预措施: Palm olein (Dietary Supplement)
Arm 3
Interesterified Palm Olein
干预措施: Interesterified palm olein (Dietary Supplement)
Arm 2
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)
