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

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)

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02479334
Enrollment
12
Registered
2015-06-24
Start date
2015-06-30
Completion date
2015-08-31
Last updated
2015-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

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

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.

Interventions

OTHERFat 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

OTHERFat 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

OTHERCarbohydrate 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

OTHERCarbohydrate 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

Sponsors

Food for Health Science Centre, Lund University
CollaboratorUNKNOWN
Lund University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

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

MeasureTime frameDescription
Subjective appetite ratings using standard subjective 100 mm VASPrior 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 biomarkersPrior 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 profilePrior 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

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026