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

Primary Purpose

Healthy

Status

Completed

Phase

Phase 1

Locations

Sweden

Study Type

Interventional

Intervention

Fat challenge breakfast

Fat challenge breakfast+spices

Carbohydrate challenge breakfast

Carbohydrate challenge breakfast+spices

About this trial

This is an interventional basic science trial for Healthy focused on measuring Spices, Functional food, Cardiometabolic risk, Metabolic syndrome, Inflammation, Peripheral blood mononuclear cell, Acute

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Food for Health Laboratory - Lund University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Arm Label

Fat challenge breakfast

Fat challenge breakfast+spices

Carbohydrate challenge breakfast

Carbohydrate challenge breakfast+spices

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Change from Baseline (0 hr) in untargeted PBMC gene expression profile at 2 hr and 4 hr

The venous blood samples will be taken for isolation of peripheral blood mononuclear cells. Extracted total RNA will then be used for running RNA-seq/whole-transcriptome shotgun sequencing (Illumina, San Diego, CA, USA)

Secondary Outcome Measures

Subjective appetite ratings using standard subjective 100 mm VAS

Appetite will be assessed using standard subjective 100 mm VAS (visual analogue scale) at time intervals throughout each visit

Metabolic biomarkers

The capillary blood samples will be taken for blood glucose analysis. The venous blood samples will be taken for further assessment of insulin, triacylglycerol, NEFA and inflammatory biomarkers (i.e. IL-6, IL-8, CRP)

Metabolite profile

Metabolite profile will be analyzed using Liquid Chromatography-Mass Spectrometry based methods

Full Information

NCT ID

NCT02479334

First Posted

March 30, 2015

Last Updated

September 19, 2015

Sponsor

Lund University

Collaborators

Food for Health Science Centre, Lund University

1. Study Identification

Unique Protocol Identification Number

NCT02479334

Brief Title

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

Official Title

Acute Effects of Spices on Pathways Associated With Glucose Homeostasis, Oxidative Stress and Inflammation in Healthy Subjects - Molecular Insights Through Transcriptomics of Peripheral Blood Mononuclear Cells (PBMC)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Completed

Study Start Date

June 2015 (undefined)

Primary Completion Date

August 2015 (Actual)

Study Completion Date

August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Lund University

Collaborators

Food for Health Science Centre, Lund University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy

Keywords

Spices, Functional food, Cardiometabolic risk, Metabolic syndrome, Inflammation, Peripheral blood mononuclear cell, Acute

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1, Phase 2

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fat challenge breakfast

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Fat challenge breakfast+spices

Arm Type

Experimental

Arm Description

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

Arm Title

Carbohydrate challenge breakfast

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Carbohydrate challenge breakfast+spices

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Fat challenge breakfast

Intervention Description

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

Intervention Name(s)

Fat challenge breakfast+spices

Intervention Description

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

Intervention Name(s)

Carbohydrate challenge breakfast

Intervention Description

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

Intervention Name(s)

Carbohydrate challenge breakfast+spices

Intervention Description

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

Primary Outcome Measure Information:

Title

Change from Baseline (0 hr) in untargeted PBMC gene expression profile at 2 hr and 4 hr

Description

Time Frame

Prior to the initial intervention at 0 hr and after intervention at 2 hr and 4 hr.

Secondary Outcome Measure Information:

Title

Subjective appetite ratings using standard subjective 100 mm VAS

Description

Appetite will be assessed using standard subjective 100 mm VAS (visual analogue scale) at time intervals throughout each visit

Time Frame

Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min.

Title

Metabolic biomarkers

Description

Time Frame

Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min.

Title

Metabolite profile

Description

Metabolite profile will be analyzed using Liquid Chromatography-Mass Spectrometry based methods

Time Frame

Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yoghatama Cindya Zanzer, MSc

Organizational Affiliation

Lund University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Elin Östman, PhD

Organizational Affiliation

Lund University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Food for Health Laboratory - Lund University

City

Lund

State/Province

Skane

ZIP/Postal Code

223 81

Country

Sweden

12. IPD Sharing Statement

Learn more about this trial

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

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