Acute Effects of Spices on Pathways Associated With Glucose Homeostasis and Inflammation on PBMCs of Healthy Subjects

NCT ID: NCT02479334

Last Updated: 2015-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2015-08-31

Brief Summary

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This study aims to investigate the effect of spices on gene expression of pathways associated with glucose homeostasis, oxidative stress and inflammation, in the postprandial phase in healthy human subjects.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Fat challenge breakfast

200 ml control drink (non-energy flavored water) and high fat breakfast (% Energy Carbohydrate:Fat:Prot / 20:60:20), acute study / one time administration

Group Type PLACEBO_COMPARATOR

Fat challenge breakfast

Intervention Type OTHER

In this intervention, subjects are asked to consume 200 ml control drinks (non-energy flavored water). Following 10 min. beverage consumption, subjects will be given standardized high fat breakfast corresponding to % Energy of Carbohydrate:Fat:Prot / 20:60:20

Fat challenge breakfast+spices

200 ml spices drink (non-energy flavored water + spices extract) and high fat breakfast (% Energy Carbohydrate:Fat:Prot / 20:60:20), acute study / one time administration

Group Type EXPERIMENTAL

Fat challenge breakfast+spices

Intervention Type OTHER

In this intervention, subjects are asked to consume 200 ml spices drinks (non-energy flavored water + spices extract). Following 10 min. beverage consumption, subjects will be given standardized high fat breakfast corresponding to % Energy of Carbohydrate:Fat:Prot / 20:60:20

Carbohydrate challenge breakfast

200 ml control drink (non-energy flavored water) and high carbohydrate breakfast (% Energy Carbohydrate:Fat:Prot / 60:20:20), acute study / one time administration

Group Type PLACEBO_COMPARATOR

Carbohydrate challenge breakfast

Intervention Type OTHER

In this intervention, subjects are asked to consume 200 ml control drinks (non-energy flavored water). Following 10 min. beverage consumption, subjects will be given standardized high carbohydrate breakfast corresponding to % Energy of Carbohydrate:Fat:Prot / 60:20:20

Carbohydrate challenge breakfast+spices

200 ml spices drink (non-energy flavored water + spices extract) and high carbohydrate breakfast (% Energy Carbohydrate:Fat:Prot / 60:20:20), acute study / one time administration

Group Type EXPERIMENTAL

Carbohydrate challenge breakfast+spices

Intervention Type OTHER

In this intervention, subjects are asked to consume 200 ml spices drinks (non-energy flavored water + spices extract). Following 10 min. beverage consumption, subjects will be given standardized high carbohydrate breakfast corresponding to % Energy of Carbohydrate:Fat:Prot / 60:20:20

Interventions

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Fat challenge breakfast

In this intervention, subjects are asked to consume 200 ml control drinks (non-energy flavored water). Following 10 min. beverage consumption, subjects will be given standardized high fat breakfast corresponding to % Energy of Carbohydrate:Fat:Prot / 20:60:20

Intervention Type OTHER

Fat challenge breakfast+spices

In this intervention, subjects are asked to consume 200 ml spices drinks (non-energy flavored water + spices extract). Following 10 min. beverage consumption, subjects will be given standardized high fat breakfast corresponding to % Energy of Carbohydrate:Fat:Prot / 20:60:20

Intervention Type OTHER

Carbohydrate challenge breakfast

In this intervention, subjects are asked to consume 200 ml control drinks (non-energy flavored water). Following 10 min. beverage consumption, subjects will be given standardized high carbohydrate breakfast corresponding to % Energy of Carbohydrate:Fat:Prot / 60:20:20

Intervention Type OTHER

Carbohydrate challenge breakfast+spices

In this intervention, subjects are asked to consume 200 ml spices drinks (non-energy flavored water + spices extract). Following 10 min. beverage consumption, subjects will be given standardized high carbohydrate breakfast corresponding to % Energy of Carbohydrate:Fat:Prot / 60:20:20

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy males and females
* BMI 20-28 kg/m2
* Must be able to accept spices
* Agreed and signed informed consent

Exclusion Criteria

* Below 18 years old
* Uncomfortable speaking English and/or difficulties in understanding spoken English
* Smoking or using snuss
* Vegetarian or vegan
* Stressed by venous blood sampling or previous experience of being difficult to be cannulated
* Receiving any drug treatment that may influence the study outcomes
* Pregnancy or breastfeeding
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Lund University

OTHER

Sponsor Role lead

Food for Health Science Centre, Lund University

UNKNOWN

Sponsor Role collaborator

Responsible Party

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Elin Östman

Assoc. Prof. PhD.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yoghatama Cindya Zanzer, MSc

Role: STUDY_CHAIR

Lund University

Elin Östman, PhD

Role: PRINCIPAL_INVESTIGATOR

Lund University

Locations

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Food for Health Laboratory - Lund University

Lund, Skåne County, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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LUND-AFC-STAGE3-SPICENUTROMICS

Identifier Type: -

Identifier Source: org_study_id

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