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

Healthy Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02479334
• Other study ID #: LUND-AFC-STAGE3-SPICENUTROMICS
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 30, 2015
• Last updated: September 19, 2015
• Start date: June 2015
• Est. completion date: August 2015

Study information

• Verified date: September 2015
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Central Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy
• Inflammation

Intervention

Other:
• 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
• 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
• 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
• 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

Locations

Country	Name	City	State
Sweden	Food for Health Laboratory - Lund University	Lund	Skane

Sponsors (2)

Lead Sponsor	Collaborator
Lund University	Food for Health Science Centre, Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Prior to the initial intervention at 0 hr and after intervention at 2 hr and 4 hr.	No
Secondary	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	Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min.	No
Secondary	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)	Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min.	No
Secondary	Metabolite profile	Metabolite profile will be analyzed using Liquid Chromatography-Mass Spectrometry based methods	Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min.	No

External Links

•   Antidiabetic Food Centre - VINNOVA Excellence Centre in Research and Innovation at Lund University, SWEDEN
•   Food for Health Science Centre, Lund University, SWEDEN