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)
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Lund University
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- Change from Baseline (0 hr) in untargeted PBMC gene expression profile at 2 hr and 4 hr
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy males and females
- •BMI 20-28 kg/m2
- •Must be able to accept spices
- •Agreed and signed informed consent
Exclusion Criteria
- •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
Arms & Interventions
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
Intervention: 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
Intervention: 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
Intervention: 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
Intervention: Carbohydrate challenge breakfast+spices (Other)
Outcomes
Primary Outcomes
Change from Baseline (0 hr) in untargeted PBMC gene expression profile at 2 hr and 4 hr
Time Frame: 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)
Secondary Outcomes
- 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.)
Investigators
Elin Östman
Assoc. Prof. PhD.
Lund University