Effect of Herbs and Spices on Metabolic Regulation and Appetite in Healthy Subjects (AFC-SPICES)

August 23, 2018 updated by: Elin Östman, Lund University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Skane
      • Lund, Skane, Sweden, 22381
        • Antidiabetic Food Centre (Medicon Village) - Lund University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Spices 1
220 ml test drink containing spices 1, acute study / one time administration
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.
Experimental: Spices 2
220 ml test drink containing spices 2, acute study / one time administration
Dietary supplement: 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.
Experimental: Spices 3
220 ml test drink containing spices 3, acute study / one time administration
Dietary supplement: 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.
Experimental: Herbs 1
220 ml test drink containing herbs 1, acute study / one time administration
Dietary supplement: 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.
Experimental: Herbs 2
220 ml test drink containing herbs 2, acute study / one time administration
Dietary supplement: 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.
Placebo Comparator: Placebo
220 ml control drink, acute study / one time administration
Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changing on blood glucose concentration after treatment with herbs and spices
Time Frame: Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 min.
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
Time Frame: Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 min.
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
Time Frame: Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 min.
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
Time Frame: Prior to the initial intervention at 0 min and up to 24-h after intervention
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
Time Frame: Prior to the initial intervention at 0 min and after intervention at 60, 90, 120, 180 min.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lund University

Collaborators

Anti-Diabetic Food Centre

Investigators

  • Principal Investigator: Elin Östman, PhD, Lund University
  • Principal Investigator: Yoghatama Cindya Zanzer, MSc, Lund University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

January 10, 2014

First Submitted That Met QC Criteria

January 10, 2014

First Posted (Estimate)

January 14, 2014

Study Record Updates

Last Update Posted (Actual)

August 27, 2018

Last Update Submitted That Met QC Criteria

August 23, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • LUND-AFC-STAGE3-SPICES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on Spices 1

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe