Acute Effects of Spices on Pathways Associated With Glucose Homeostasis and Inflammation on PBMCs of Healthy Subjects
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Jun 2015
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedFirst Posted
Study publicly available on registry
June 24, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedSeptember 22, 2015
September 1, 2015
2 months
March 30, 2015
September 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Secondary Outcomes (3)
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.
Metabolic biomarkers
Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min.
Metabolite profile
Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min.
Study Arms (4)
Fat challenge breakfast
PLACEBO COMPARATOR200 ml control drink (non-energy flavored water) and high fat breakfast (% Energy Carbohydrate:Fat:Prot / 20:60:20), acute study / one time administration
Fat challenge breakfast+spices
EXPERIMENTAL200 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
Carbohydrate challenge breakfast
PLACEBO COMPARATOR200 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
EXPERIMENTAL200 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
Interventions
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
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
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
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
Eligibility Criteria
You may qualify if:
- Healthy males and females
- BMI 20-28 kg/m2
- Must be able to accept spices
- Agreed and signed informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lund Universitylead
- Food for Health Science Centre, Lund Universitycollaborator
Study Sites (1)
Food for Health Laboratory - Lund University
Lund, Skåne County, 223 81, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yoghatama Cindya Zanzer, MSc
Lund University
- PRINCIPAL INVESTIGATOR
Elin Östman, PhD
Lund University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assoc. Prof. PhD.
Study Record Dates
First Submitted
March 30, 2015
First Posted
June 24, 2015
Study Start
June 1, 2015
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
September 22, 2015
Record last verified: 2015-09