NCT02035241

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Mar 2014

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 14, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

August 27, 2018

Status Verified

August 1, 2018

Enrollment Period

3 months

First QC Date

January 10, 2014

Last Update Submit

August 23, 2018

Conditions

Keywords

SpicesHerbsFunctional foodCardiometabolic riskMetabolic syndromeInflammationAppetiteGut hormone

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Changing on subjective appetite ratings after treatment with herbs and spices

    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

    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

    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

    Prior to the initial intervention at 0 min and after intervention at 60, 90, 120, 180 min.

Study Arms (6)

Spices 1

EXPERIMENTAL

220 ml test drink containing spices 1, acute study / one time administration

Dietary Supplement: Spices 1

Spices 2

EXPERIMENTAL

220 ml test drink containing spices 2, acute study / one time administration

Dietary Supplement: Spices 2

Spices 3

EXPERIMENTAL

220 ml test drink containing spices 3, acute study / one time administration

Dietary Supplement: Spices 3

Herbs 1

EXPERIMENTAL

220 ml test drink containing herbs 1, acute study / one time administration

Dietary Supplement: Herbs 1

Herbs 2

EXPERIMENTAL

220 ml test drink containing herbs 2, acute study / one time administration

Dietary Supplement: Herbs 2

Placebo

PLACEBO COMPARATOR

220 ml control drink, acute study / one time administration

Dietary Supplement: Control drink

Interventions

Spices 1DIETARY_SUPPLEMENT

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 1
Spices 2DIETARY_SUPPLEMENT

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 2
Spices 3DIETARY_SUPPLEMENT

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.

Spices 3
Herbs 1DIETARY_SUPPLEMENT

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 1
Herbs 2DIETARY_SUPPLEMENT

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.

Herbs 2
Control drinkDIETARY_SUPPLEMENT

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.

Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antidiabetic Food Centre (Medicon Village) - Lund University

Lund, Skåne County, 22381, Sweden

Location

Related Links

MeSH Terms

Conditions

Metabolic SyndromeInflammation

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Elin Östman, PhD

    Lund University

    PRINCIPAL INVESTIGATOR
  • Yoghatama Cindya Zanzer, MSc

    Lund University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof, PhD

Study Record Dates

First Submitted

January 10, 2014

First Posted

January 14, 2014

Study Start

March 1, 2014

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

August 27, 2018

Record last verified: 2018-08

Locations