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

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ClinicalTrials.gov Identifier: NCT02035241
Recruitment Status : Completed
First Posted : January 14, 2014
Last Update Posted : August 27, 2018
Sponsor:
Collaborator:
Anti-Diabetic Food Centre
Information provided by (Responsible Party):
Elin Östman, Lund University

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Spices 1 Dietary Supplement: Spices 2 Dietary Supplement: Spices 3 Dietary Supplement: Herbs 1 Dietary Supplement: Herbs 2 Dietary Supplement: Control drink Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Investigation on Effect of Herbs and Spices on Glucose and Insulin Responses, Anti-inflammatory Properties, Antioxidative Capacity and Satiety in Healthy Subjects
Study Start Date : March 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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)

  3. 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

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02035241


Locations
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Sweden
Antidiabetic Food Centre (Medicon Village) - Lund University
Lund, Skane, Sweden, 22381
Sponsors and Collaborators
Lund University
Anti-Diabetic Food Centre
Investigators
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Principal Investigator: Elin Östman, PhD Lund University
Principal Investigator: Yoghatama Cindya Zanzer, MSc Lund University
Additional Information:
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Responsible Party: Elin Östman, Assoc. Prof, PhD, Lund University
ClinicalTrials.gov Identifier: NCT02035241    
Other Study ID Numbers: LUND-AFC-STAGE3-SPICES
First Posted: January 14, 2014    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018
Keywords provided by Elin Östman, Lund University:
Spices
Herbs
Functional food
Cardiometabolic risk
Metabolic syndrome
Inflammation
Appetite
Gut hormone