NCT02931643已完成不适用
Postprandial Effects of Mixed Herbs and Spices on Pathways Associated With Glucose Homeostasis and Inflammation on PBMCs of Healthy Subjects - Molecular Insights Through Integration of Transcriptomics of Peripheral Blood Mononuclear Cells (PBMC) and Circulating miRNA
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
- 18
- 试验地点
- 2
- 主要终点
- Change from Baseline (0 hr) in untargeted PBMC gene expression profile at 4 hr
研究概览
简要总结
This study aims to investigate the effect of mixed of herbs and spices on gene expression of pathways associated with glucose homeostasis, oxidative stress, inflammation and its interrelation with circulating miRNA, in the postprandial phase in healthy human subjects.
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females
- •BMI 23-33 kg/m2
- •Must be able to accept spices
- •Agreed and signed informed consent
排除标准
- •Below 18 years old
- •Uncomfortable speaking English and/or difficulties in understanding spoken English
- •Smoking or using snuss
- •Vegetarian or vegan
- •Having food allergies
- •Stressed by venous blood sampling or previous experience of being difficult to be cannulated
- •Receiving any drug treatment that may influence the study outcomes
- •Pregnancy or breastfeeding
研究组 & 干预措施
High fat challenge breakfast
Placebo Comparator
High fat breakfast without mixed-spices (% Energy Carbohydrate:Fat:Prot / 20:60:20), acute study / one time administration
干预措施: High fat challenge breakfast (Other)
High fat challenge breakfast with mixed-spices
Experimental
High fat breakfast with mixed-spices (% Energy Carbohydrate:Fat:Prot / 20:60:20), acute study / one time administration
干预措施: High fat challenge breakfast with mixed-spices (Other)
结局指标
主要结局
Change from Baseline (0 hr) in untargeted PBMC gene expression profile at 4 hr
时间窗: Prior to the initial intervention at 0 hr and after intervention at 4 hr
The venous blood samples will be taken for isolation of peripheral blood mononuclear cells. Extracted total RNA will then be used for running RNA-microarray (Illumina, San Diego, CA, USA)
次要结局
- Postprandial interleukin (IL)-6 after acute intervention(Prior to the initial intervention at 0 min and after intervention at 120 and 240 min.)
- Postprandial gastrointestinal tolerance ratings after acute intervention(Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min.)
- Postprandial high density lipoprotein (HDL)-cholesterol after acute intervention(Prior to the initial intervention at 0 min and after intervention at 30, 60, 90, 120, 180 and 240 min.)
- Postprandial non-esterified fatty acids (NEFA) after acute intervention(Prior to the initial intervention at 0 min and after intervention at 30, 60, 90, 120, 180 and 240 min.)
- Postprandial interleukin (IL)-10 after acute intervention(Prior to the initial intervention at 0 min and after intervention at 120 and 240 min.)
- Postprandial appetite ratings after acute intervention(Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min.)
- Postprandial blood glucose after acute intervention(Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min.)
- Postprandial insulin after acute intervention(Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min.)
- Postprandial triacylglycerol after acute intervention(Prior to the initial intervention at 0 min and after intervention at 30, 60, 90, 120, 180 and 240 min.)
- Postprandial total cholesterol after acute intervention(Prior to the initial intervention at 0 min and after intervention at 30, 60, 90, 120, 180 and 240 min.)
- Postprandial lipid peroxidation (MDA equivalent) after acute intervention(Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min.)
- Postprandial total antioxidant capacity after acute intervention(Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min.)
- Postprandial low density lipoprotein (LDL)-cholesterol after acute intervention(Prior to the initial intervention at 0 min and after intervention at 30, 60, 90, 120, 180 and 240 min.)
- Postprandial tumor necrosis factor (TNF)-alpha after acute intervention(Prior to the initial intervention at 0 min and after intervention at 120 and 240 min.)
- Change from Baseline (0 hr) in untargeted circulating miRNA profile at 4 hr(Prior to the initial intervention at 0 hr and after intervention at 4 hr)
研究者
研究点 (2)
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