Acute Effects of Spices on Pathways Associated With Glucose Homeostasis and Inflammation on PBMCs of Healthy Subjects

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Healthy

Intervention / Treatment
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* Other: Fat challenge breakfast
* Other: Fat challenge breakfast+spices
* Other: Carbohydrate challenge breakfast
* Other: Carbohydrate challenge breakfast+spices


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Fat challenge breakfast<br>200 ml control drink (non-energy flavored water) and high fat breakfast (% Energy Carbohydrate:Fat:Prot / 20:60:20), acute study / one time administration | Other: Fat challenge breakfast<br>* In this intervention, subjects are asked to consume 200 ml control drinks (non-energy flavored water). Following 10 min. beverage consumption, subjects will be given standardized high fat breakfast corresponding to % Energy of Carbohydrate:Fat:Prot / 20:60:20<br>|
| Experimental: Fat challenge breakfast+spices<br>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 | Other: Fat challenge breakfast+spices<br>* In this intervention, subjects are asked to consume 200 ml spices drinks (non-energy flavored water + spices extract). Following 10 min. beverage consumption, subjects will be given standardized high fat breakfast corresponding to % Energy of Carbohydrate:Fat:Prot / 20:60:20<br>|
| Placebo Comparator: Carbohydrate challenge breakfast<br>200 ml control drink (non-energy flavored water) and high carbohydrate breakfast (% Energy Carbohydrate:Fat:Prot / 60:20:20), acute study / one time administration | Other: Carbohydrate challenge breakfast<br>* In this intervention, subjects are asked to consume 200 ml control drinks (non-energy flavored water). Following 10 min. beverage consumption, subjects will be given standardized high carbohydrate breakfast corresponding to % Energy of Carbohydrate:Fat:Prot / 60:20:20<br>|
| Experimental: Carbohydrate challenge breakfast+spices<br>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 | Other: Carbohydrate challenge breakfast+spices<br>* In this intervention, subjects are asked to consume 200 ml spices drinks (non-energy flavored water + spices extract). Following 10 min. beverage consumption, subjects will be given standardized high carbohydrate breakfast corresponding to % Energy of Carbohydrate:Fat:Prot / 60:20:20<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline (0 hr) in untargeted PBMC gene expression profile 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) | Prior to the initial intervention at 0 hr and after intervention at 2 hr and 4 hr. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective appetite ratings using standard subjective 100 mm VAS | Appetite will be assessed using standard subjective 100 mm VAS (visual analogue scale) at time intervals throughout each visit | Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min. | 
| Metabolic biomarkers | The capillary blood samples will be taken for blood glucose analysis. The venous blood samples will be taken for further assessment of insulin, triacylglycerol, NEFA and inflammatory biomarkers (i.e. IL-6, IL-8, CRP) | Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min. | 
| Metabolite profile | Metabolite profile will be analyzed using Liquid Chromatography-Mass Spectrometry based methods | Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spices, Functional food, Cardiometabolic risk, Metabolic syndrome, Inflammation, Peripheral blood mononuclear cell, Acute