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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02035241
Other study ID # LUND-AFC-STAGE3-SPICES
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2014
Est. completion date June 2014

Study information

Verified date August 2018
Source Lund University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Spices 1
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.
Spices 2
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.
Spices 3
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.
Herbs 1
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.
Herbs 2
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.
Control drink
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.

Locations

Country Name City State
Sweden Antidiabetic Food Centre (Medicon Village) - Lund University Lund Skane

Sponsors (2)

Lead Sponsor Collaborator
Lund University Anti-Diabetic Food Centre

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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.
Secondary 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.
Secondary 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
Secondary 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.
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