- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02931643
Postprandial Effects of Mixed Herbs and Spices on Pathways Associated With Glucose Homeostasis and Inflammation on PBMCs of Healthy Subjects
June 4, 2018 updated by: Yoghatama Cindya Zanzer, Lund University
Postprandial Effects of Mixed Herbs and Spices on Pathways Associated With Glucose Homeostasis and Inflammation on PBMCs of Healthy Subjects - Molecular Insights Through Integration of Transcriptomics of Peripheral Blood Mononuclear Cells (PBMC) and Circulating miRNA
This study aims to investigate the effect of mixed of herbs and spices on gene expression of pathways associated with glucose homeostasis, oxidative stress, inflammation and its interrelation with circulating miRNA, in the postprandial phase in healthy human subjects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Skåne
-
Lund, Skåne, Sweden, 22381
- Food for Health Science Centre, Lund University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy males and females
- BMI 23-33 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
- Having food allergies
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: High fat challenge breakfast
High fat breakfast without mixed-spices (% Energy Carbohydrate:Fat:Prot / 20:60:20), acute study / one time administration
|
In this intervention, subjects are asked to consume high fat breakfast without mixed-spices.
Standardized high fat breakfast corresponding to % Energy of Carbohydrate:Fat:Prot / 20:60:20
|
Experimental: High fat challenge breakfast with mixed-spices
High fat breakfast with mixed-spices (% Energy Carbohydrate:Fat:Prot / 20:60:20), acute study / one time administration
|
In this intervention, subjects are asked to consume high fat breakfast with mixed-spices.
Standardized high fat breakfast corresponding to % Energy of Carbohydrate:Fat:Prot / 20:60:20
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline (0 hr) in untargeted PBMC gene expression profile at 4 hr
Time Frame: Prior to the initial intervention at 0 hr and after intervention at 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-microarray (Illumina, San Diego, CA, USA)
|
Prior to the initial intervention at 0 hr and after intervention at 4 hr
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postprandial appetite ratings after acute intervention
Time Frame: 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 respective time frame throughout each visit.
Appetite questionnaire includes following questions: How hungry do you feel?, How strong is your desire to eat?, How satiated (i.e.
pleasantly satisfied) are you?, How full do you feel?, How much food do you think you can (or would want to) eat?, How thirsty are you?
|
Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min.
|
Postprandial gastrointestinal tolerance ratings after acute intervention
Time Frame: Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min.
|
Gastrointestinal tolerance will be assessed using standard subjective 100 mm VAS (visual analogue scale) at respective time frame throughout each visit.
Gastrointestinal tolerance questionnaire includes following questions: Do you experience any abdominal pain?, Do you experience any rumbling noises in your stomach?, Do you experience any flatulence (generation of excessive gas)?, Do you experience any bloated (swollen) feeling in the abdomen?, Do you experience any acid reflux (heartburn)?, Do you experience nausea?, Do you experience an urge to vomit?
|
Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min.
|
Postprandial blood glucose after acute intervention
Time Frame: 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.
|
Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min.
|
Postprandial insulin after acute intervention
Time Frame: Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min.
|
The venous blood samples will be taken for insulin analysis.
Insulin analysis will be conducted with routine hospital analysis at Labmedicine Skåne.
|
Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min.
|
Postprandial triacylglycerol after acute intervention
Time Frame: Prior to the initial intervention at 0 min and after intervention at 30, 60, 90, 120, 180 and 240 min.
|
The venous blood samples will be taken for plasma triacylglycerol analysis.
Plasma triacylglycerol analysis will be conducted with routine hospital analysis at Labmedicine Skåne.
|
Prior to the initial intervention at 0 min and after intervention at 30, 60, 90, 120, 180 and 240 min.
|
Postprandial non-esterified fatty acids (NEFA) after acute intervention
Time Frame: Prior to the initial intervention at 0 min and after intervention at 30, 60, 90, 120, 180 and 240 min.
|
The venous blood samples will be taken for serum NEFA analysis.
Serum NEFA analysis will be conducted with routine hospital analysis at Labmedicine Skåne.
|
Prior to the initial intervention at 0 min and after intervention at 30, 60, 90, 120, 180 and 240 min.
|
Postprandial total cholesterol after acute intervention
Time Frame: Prior to the initial intervention at 0 min and after intervention at 30, 60, 90, 120, 180 and 240 min.
|
The venous blood samples will be taken for plasma total cholesterol analysis.
Plasma total cholesterol analysis will be conducted with routine hospital analysis at Labmedicine Skåne.
|
Prior to the initial intervention at 0 min and after intervention at 30, 60, 90, 120, 180 and 240 min.
|
Postprandial high density lipoprotein (HDL)-cholesterol after acute intervention
Time Frame: Prior to the initial intervention at 0 min and after intervention at 30, 60, 90, 120, 180 and 240 min.
|
The venous blood samples will be taken for plasma HDL-cholesterol analysis.
Plasma HDL-cholesterol analysis will be conducted with routine hospital analysis at Labmedicine Skåne.
|
Prior to the initial intervention at 0 min and after intervention at 30, 60, 90, 120, 180 and 240 min.
|
Postprandial low density lipoprotein (LDL)-cholesterol after acute intervention
Time Frame: Prior to the initial intervention at 0 min and after intervention at 30, 60, 90, 120, 180 and 240 min.
|
The venous blood samples will be taken for plasma LDL-cholesterol analysis.
Plasma LDL-cholesterol analysis will be conducted with routine hospital analysis at Labmedicine Skåne.
|
Prior to the initial intervention at 0 min and after intervention at 30, 60, 90, 120, 180 and 240 min.
|
Postprandial interleukin (IL)-6 after acute intervention
Time Frame: Prior to the initial intervention at 0 min and after intervention at 120 and 240 min.
|
The venous blood samples will be taken for serum interleukin IL-6 analysis.
Serum IL-6 analysis will be conducted with routine hospital analysis at Labmedicine Skåne.
|
Prior to the initial intervention at 0 min and after intervention at 120 and 240 min.
|
Postprandial interleukin (IL)-10 after acute intervention
Time Frame: Prior to the initial intervention at 0 min and after intervention at 120 and 240 min.
|
The venous blood samples will be taken for serum interleukin IL-10 analysis.
Serum IL-10 analysis will be conducted with routine hospital analysis at Labmedicine Skåne.
|
Prior to the initial intervention at 0 min and after intervention at 120 and 240 min.
|
Postprandial tumor necrosis factor (TNF)-alpha after acute intervention
Time Frame: Prior to the initial intervention at 0 min and after intervention at 120 and 240 min.
|
The venous blood samples will be taken for serum TNF-alpha analysis.
Serum TNF-alpha analysis will be conducted with routine hospital analysis at Labmedicine Skåne.
|
Prior to the initial intervention at 0 min and after intervention at 120 and 240 min.
|
Postprandial lipid peroxidation (MDA equivalent) after acute intervention
Time Frame: Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min.
|
The venous blood samples will be taken for lipid peroxidation (MDA) assay.
|
Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min.
|
Postprandial total antioxidant capacity after acute intervention
Time Frame: Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min.
|
The venous blood samples will be taken for total antioxidant capacity (FRAP) assay.
|
Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min.
|
Change from Baseline (0 hr) in untargeted circulating miRNA profile at 4 hr
Time Frame: Prior to the initial intervention at 0 hr and after intervention at 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 miRNA (Affymetrix, Santa Clara, CA, USA)
|
Prior to the initial intervention at 0 hr and after intervention at 4 hr
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Yoghatama Cindya Zanzer, MSc PhDcand, Lund University
- Principal Investigator: Elin Östman, PhD A/Prof, Lund University
- Study Chair: Congyu Xue, BSc, Lund University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2016
Primary Completion (Actual)
November 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
October 11, 2016
First Submitted That Met QC Criteria
October 11, 2016
First Posted (Estimate)
October 13, 2016
Study Record Updates
Last Update Posted (Actual)
June 6, 2018
Last Update Submitted That Met QC Criteria
June 4, 2018
Last Verified
October 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LUND-AFCSTAGE4-SPICEMULTIOMICS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on High fat challenge breakfast
-
Lund UniversityFood for Health Science Centre, Lund UniversityCompleted
-
University of Alabama at BirminghamCompletedHeart Diseases | Diabetes
-
Maastricht University Medical CenterTop Institute Food and NutritionCompletedPostprandial IHL and IMCL DynamicsNetherlands
-
University of British ColumbiaUniversity of WollongongCompleted
-
Drugs for Neglected DiseasesQuotient SciencesCompletedGonorrheaUnited States
-
Texas Tech UniversityPennington Biomedical Research Center; American Egg BoardCompletedDiabetes Mellitus, Type 2 | Insulin ResistanceUnited States
-
Boehringer IngelheimCompleted
-
Janssen-Cilag International NVCompleted
-
USDA, Western Human Nutrition Research CenterRecruiting
-
Boehringer IngelheimCompleted