Postprandial Effects of Mixed Herbs and Spices on Pathways Associated With Glucose Homeostasis and Inflammation on PBMCs of Healthy Subjects

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02931643
• Other study ID #: LUND-AFCSTAGE4-SPICEMULTIOMICS
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: December 2016

Study information

• Verified date: October 2016
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Inflammation

Intervention

Other:
• High fat challenge breakfast
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
• High fat challenge breakfast with mixed-spices
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

Locations

Country	Name	City	State
Sweden	Food for Health Science Centre, Lund University	Lund	Skåne

Sponsors (2)

Lead Sponsor	Collaborator
Lund University	Anti-Diabetic Food Centre

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 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	Postprandial appetite ratings after acute intervention	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.
Secondary	Postprandial gastrointestinal tolerance ratings after acute intervention	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.
Secondary	Postprandial blood glucose after acute intervention	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.
Secondary	Postprandial insulin after acute intervention	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.
Secondary	Postprandial triacylglycerol after acute intervention	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.
Secondary	Postprandial non-esterified fatty acids (NEFA) after acute intervention	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.
Secondary	Postprandial total cholesterol after acute intervention	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.
Secondary	Postprandial high density lipoprotein (HDL)-cholesterol after acute intervention	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.
Secondary	Postprandial low density lipoprotein (LDL)-cholesterol after acute intervention	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.
Secondary	Postprandial interleukin (IL)-6 after acute intervention	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.
Secondary	Postprandial interleukin (IL)-10 after acute intervention	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.
Secondary	Postprandial tumor necrosis factor (TNF)-alpha after acute intervention	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.
Secondary	Postprandial lipid peroxidation (MDA equivalent) after acute intervention	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.
Secondary	Postprandial total antioxidant capacity after acute intervention	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.
Secondary	Change from Baseline (0 hr) in untargeted circulating miRNA profile 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

External Links

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