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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Other: Fat challenge breakfast+spices; Other: Fat challenge breakfast; Other: Carbohydrate challenge breakfast; Other: Carbohydrate challenge breakfast+spices

• Registration Number: NCT02479334
• Lead Sponsor: Lund University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-30
• Study Start: 2015-06
• Study First Submitted QC: 2015-06-19
• Study First Posted: 2015-06-24
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-19
• Last Update Posted: 2015-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Fat challenge breakfast+spices	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
Fat challenge breakfast	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
Carbohydrate challenge breakfast	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
Carbohydrate challenge breakfast+spices	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

Primary Outcome Measures

Name	Time	Method
Change from Baseline (0 hr) in untargeted PBMC gene expression profile at 2 hr and 4 hr	Prior to the initial intervention at 0 hr and after intervention 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

Name	Time	Method
Subjective appetite ratings using standard subjective 100 mm VAS	Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min.	Appetite will be assessed using standard subjective 100 mm VAS (visual analogue scale) at time intervals throughout each visit
Metabolic biomarkers	Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min.	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	Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min.	Metabolite profile will be analyzed using Liquid Chromatography-Mass Spectrometry based methods

Trial Locations

Locations (1)

Food for Health Laboratory - Lund University; 🇸🇪 Lund, Skane, Sweden