Effect of Herbs and Spices on Metabolic Regulation and Appetite in Healthy Subjects

Study Overview
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Brief Summary
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The purpose of the study is to investigate how herbs and spices affect acute/postprandial glucose and insulin responses, inflammatory markers, appetite control peptides, antioxidative capacity, as well as subjective appetite ratings (VAS-visual analogue scales) in healthy volunteers. We hypothesize that certain herbs and spices added to a standardized meal will improve postprandial glucose tolerance and other metabolic biomarkers in healthy volunteers, compared with a similar meal without the corresponding plant materials.

Detailed Description
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The aims of the study is to investigate whether consumption of preload isovolumetric (220 ml) spice-based beverages contained total polyphenol concentration to 185 mg gallic-acid equivalents followed by white wheat bread challenge (contained 50 g available carbohydrate) might affect postprandial glucose metabolism, inflammatory markers, appetite-related gut hormones, plasma antioxidant capacity, as well as appetite sensations in healthy subjects.

Official Title
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Investigation on Effect of Herbs and Spices on Glucose and Insulin Responses, Anti-inflammatory Properties, Antioxidative Capacity and Satiety in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Spices 1
* Dietary Supplement: Spices 2
* Dietary Supplement: Spices 3
* Dietary Supplement: Herbs 1
* Dietary Supplement: Herbs 2
* Dietary Supplement: Control drink


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy males and females Signed informed consent BMI 20 - 28 kg/m2 with weight change <3 kg latest 2 months) Must be able to accept herbs and spices Exclusion Criteria: Below 18 years Uncomfortable speaking English and/or difficulties in understanding spoken English Smoking or using snuff Vegetarian or vegan Stressed by venous blood sampling or previous experience of being difficult to cannulate 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 |
| --- | --- |
| Experimental: Spices 1<br>220 ml test drink containing spices 1, acute study / one time administration | Dietary Supplement: Spices 1<br>* In this study, subjects are asked to consume 200 ml beverage drinks contain certain amounts of spices 1. Following 10 min. beverage consumption, subjects will be given standardized breakfast corresponding to 50 g carbohydrate.<br>|
| Experimental: Spices 2<br>220 ml test drink containing spices 2, acute study / one time administration | Dietary Supplement: Spices 2<br>* In this study, subjects are asked to consume 200 ml beverage drinks contain certain amounts of spices 2. Following 10 min. beverage consumption, subjects will be given standardized breakfast corresponding to 50 g carbohydrate.<br>|
| Experimental: Spices 3<br>220 ml test drink containing spices 3, acute study / one time administration | Dietary Supplement: Spices 3<br>* In this study, subjects are asked to consume 200 ml beverage drinks contain certain amounts of spices 3. Following 10 min. beverage consumption, subjects will be given standardized breakfast corresponding to 50 g carbohydrate.<br>|
| Experimental: Herbs 1<br>220 ml test drink containing herbs 1, acute study / one time administration | Dietary Supplement: Herbs 1<br>* In this study, subjects are asked to consume 200 ml beverage drinks contain certain amounts of herbs 1. Following 10 min. beverage consumption, subjects will be given standardized breakfast corresponding to 50 g carbohydrate.<br>|
| Experimental: Herbs 2<br>220 ml test drink containing herbs 2, acute study / one time administration | Dietary Supplement: Herbs 2<br>* In this study, subjects are asked to consume 200 ml beverage drinks contain certain amounts of herbs 2. Following 10 min. beverage consumption, subjects will be given standardized breakfast corresponding to 50 g carbohydrate.<br>|
| Placebo Comparator: Placebo<br>220 ml control drink, acute study / one time administration | Dietary Supplement: Control drink<br>* As a control, subjects are asked to consume 200 ml control drinks. Following 10 min. beverage consumption, subjects will be given standardized breakfast corresponding to 50 g carbohydrate.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changing on blood glucose concentration after treatment with herbs and spices | 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 min. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changing on subjective appetite ratings after treatment with herbs and spices | 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 min. | 
| Changing on metabolic biomarkers after treatment with herbs and spices | The venous blood samples will be taken for insulin, inflammatory markers (i.e. interleukin-6, interleukin-8, tumor necrosis factor-alpha, necrosis factor kappa-beta, adiponectin and C-reactive protein), appetite-related gut hormones (i.e. glucagon-like peptide-1 and peptide tyrosine-tyrosine) | Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 min. | 
| Changing on urine metabolite profile after treatment with herbs and spices | Metabolite profile will be analyzed using Liquid Chromatography-Mass Spectrometry based methods | Prior to the initial intervention at 0 min and up to 24-h after intervention | 
| Changing on plasma metabolite profile after treatment with herbs and spices | Metabolite profile will be analyzed using Liquid Chromatography-Mass Spectrometry based methods | Prior to the initial intervention at 0 min and after intervention at 60, 90, 120, 180 min. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spices, Herbs, Functional food, Cardiometabolic risk, Metabolic syndrome, Inflammation, Appetite, Gut hormone