Postprandial Effects of Mixed Herbs and 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 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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Other: High fat challenge breakfast
* Other: High fat challenge breakfast with mixed-spices


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy males and females BMI 23-33 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 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

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: High fat challenge breakfast<br>High fat breakfast without mixed-spices (% Energy Carbohydrate:Fat:Prot / 20:60:20), acute study / one time administration | Other: High fat challenge breakfast<br>* In this intervention, subjects are asked to consume high fat breakfast without mixed-spices. Standardized high fat breakfast corresponding to % Energy of Carbohydrate:Fat:Prot / 20:60:20<br>|
| Experimental: High fat challenge breakfast with mixed-spices<br>High fat breakfast with mixed-spices (% Energy Carbohydrate:Fat:Prot / 20:60:20), acute study / one time administration | Other: High fat challenge breakfast with mixed-spices<br>* In this intervention, subjects are asked to consume high fat breakfast with mixed-spices. Standardized high fat breakfast corresponding to % Energy of Carbohydrate:Fat:Prot / 20:60:20<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 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) | Prior to the initial intervention at 0 hr and after intervention at 4 hr | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial appetite ratings after acute intervention | Appetite will be assessed using standard subjective 100 mm VAS (visual analogue scale) at respective time frame throughout each visit. Appetite questionnaire includes following questions: How hungry do you feel?, How strong is your desire to eat?, How satiated (i.e. pleasantly satisfied) are you?, How full do you feel?, How much food do you think you can (or would want to) eat?, How thirsty are you? | Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min. | 
| Postprandial gastrointestinal tolerance ratings after acute intervention | Gastrointestinal tolerance will be assessed using standard subjective 100 mm VAS (visual analogue scale) at respective time frame throughout each visit. Gastrointestinal tolerance questionnaire includes following questions: Do you experience any abdominal pain?, Do you experience any rumbling noises in your stomach?, Do you experience any flatulence (generation of excessive gas)?, Do you experience any bloated (swollen) feeling in the abdomen?, Do you experience any acid reflux (heartburn)?, Do you experience nausea?, Do you experience an urge to vomit? | 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 | The capillary blood samples will be taken for blood glucose analysis. | 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 | The venous blood samples will be taken for insulin analysis. Insulin analysis will be conducted with routine hospital analysis at Labmedicine Skåne. | 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 | The venous blood samples will be taken for plasma triacylglycerol analysis. Plasma triacylglycerol analysis will be conducted with routine hospital analysis at Labmedicine Skåne. | 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 | The venous blood samples will be taken for serum NEFA analysis. Serum NEFA analysis will be conducted with routine hospital analysis at Labmedicine Skåne. | 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 | The venous blood samples will be taken for plasma total cholesterol analysis. Plasma total cholesterol analysis will be conducted with routine hospital analysis at Labmedicine Skåne. | Prior to the initial intervention at 0 min and after intervention at 30, 60, 90, 120, 180 and 240 min. | 
| Postprandial high density lipoprotein (HDL)-cholesterol after acute intervention | The venous blood samples will be taken for plasma HDL-cholesterol analysis. Plasma HDL-cholesterol analysis will be conducted with routine hospital analysis at Labmedicine Skåne. | Prior to the initial intervention at 0 min and after intervention at 30, 60, 90, 120, 180 and 240 min. | 
| Postprandial low density lipoprotein (LDL)-cholesterol after acute intervention | The venous blood samples will be taken for plasma LDL-cholesterol analysis. Plasma LDL-cholesterol analysis will be conducted with routine hospital analysis at Labmedicine Skåne. | Prior to the initial intervention at 0 min and after intervention at 30, 60, 90, 120, 180 and 240 min. | 
| Postprandial interleukin (IL)-6 after acute intervention | The venous blood samples will be taken for serum interleukin IL-6 analysis. Serum IL-6 analysis will be conducted with routine hospital analysis at Labmedicine Skåne. | Prior to the initial intervention at 0 min and after intervention at 120 and 240 min. | 
| Postprandial interleukin (IL)-10 after acute intervention | The venous blood samples will be taken for serum interleukin IL-10 analysis. Serum IL-10 analysis will be conducted with routine hospital analysis at Labmedicine Skåne. | Prior to the initial intervention at 0 min and after intervention at 120 and 240 min. | 
| Postprandial tumor necrosis factor (TNF)-alpha after acute intervention | The venous blood samples will be taken for serum TNF-alpha analysis. Serum TNF-alpha analysis will be conducted with routine hospital analysis at Labmedicine Skåne. | Prior to the initial intervention at 0 min and after intervention at 120 and 240 min. | 
| Postprandial lipid peroxidation (MDA equivalent) after acute intervention | The venous blood samples will be taken for lipid peroxidation (MDA) assay. | 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 | The venous blood samples will be taken for total antioxidant capacity (FRAP) assay. | Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min. | 
| Change from Baseline (0 hr) in untargeted circulating miRNA profile 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 miRNA (Affymetrix, Santa Clara, CA, USA) | Prior to the initial intervention at 0 hr and after intervention at 4 hr | 

 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, miRNA