Acute Effects of Spices on Pathways Associated With Glucose Homeostasis, Oxidative Stress and Inflammation in Healthy Subjects - Molecular Insights Through Transcriptomics of Peripheral Blood Mononuclear Cells (PBMC)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change from Baseline (0 hr) in untargeted PBMC gene expression profile at 2 hr and 4 hr
研究概览
简要总结
This study aims to investigate the effect of spices on gene expression of pathways associated with glucose homeostasis, oxidative stress and inflammation, 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 20-28 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
- •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
Fat challenge breakfast+spices
200 ml spices drink (non-energy flavored water + spices extract) and high fat breakfast (% Energy Carbohydrate:Fat:Prot / 20:60:20), acute study / one time administration
干预措施: Fat challenge breakfast+spices (Other)
Fat challenge breakfast
200 ml control drink (non-energy flavored water) and high fat breakfast (% Energy Carbohydrate:Fat:Prot / 20:60:20), acute study / one time administration
干预措施: Fat challenge breakfast (Other)
Carbohydrate challenge breakfast
200 ml control drink (non-energy flavored water) and high carbohydrate breakfast (% Energy Carbohydrate:Fat:Prot / 60:20:20), acute study / one time administration
干预措施: Carbohydrate challenge breakfast (Other)
Carbohydrate challenge breakfast+spices
200 ml spices drink (non-energy flavored water + spices extract) and high carbohydrate breakfast (% Energy Carbohydrate:Fat:Prot / 60:20:20), acute study / one time administration
干预措施: Carbohydrate challenge breakfast+spices (Other)
结局指标
主要结局
Change from Baseline (0 hr) in untargeted PBMC gene expression profile at 2 hr and 4 hr
时间窗: Prior to the initial intervention at 0 hr and after intervention at 2 hr and 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-seq/whole-transcriptome shotgun sequencing (Illumina, San Diego, CA, USA)
次要结局
- Subjective appetite ratings using standard subjective 100 mm VAS(Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min.)
- Metabolic biomarkers(Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min.)
- Metabolite profile(Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min.)
研究者
Elin Östman
Assoc. Prof. PhD.
Lund University