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

Primary Purpose

Healthy

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
High fat challenge breakfast
High fat challenge breakfast with mixed-spices
Sponsored by
Lund University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy focused on measuring Spices, Functional food, Cardiometabolic risk, Metabolic syndrome, Inflammation, Peripheral blood mononuclear cell, Acute, miRNA

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Food for Health Science Centre, Lund University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

High fat challenge breakfast

High fat challenge breakfast with mixed-spices

Arm Description

High fat breakfast without mixed-spices (% Energy Carbohydrate:Fat:Prot / 20:60:20), acute study / one time administration

High fat breakfast with mixed-spices (% Energy Carbohydrate:Fat:Prot / 20:60:20), acute study / one time administration

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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?
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?
Postprandial blood glucose after acute intervention
The capillary blood samples will be taken for blood glucose analysis.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Postprandial lipid peroxidation (MDA equivalent) after acute intervention
The venous blood samples will be taken for lipid peroxidation (MDA) assay.
Postprandial total antioxidant capacity after acute intervention
The venous blood samples will be taken for total antioxidant capacity (FRAP) assay.
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)

Full Information

First Posted
October 11, 2016
Last Updated
June 4, 2018
Sponsor
Lund University
Collaborators
Anti-Diabetic Food Centre
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1. Study Identification

Unique Protocol Identification Number
NCT02931643
Brief Title
Postprandial Effects of Mixed Herbs and Spices on Pathways Associated With Glucose Homeostasis and Inflammation on PBMCs of Healthy Subjects
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lund University
Collaborators
Anti-Diabetic Food Centre

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
Spices, Functional food, Cardiometabolic risk, Metabolic syndrome, Inflammation, Peripheral blood mononuclear cell, Acute, miRNA

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High fat challenge breakfast
Arm Type
Placebo Comparator
Arm Description
High fat breakfast without mixed-spices (% Energy Carbohydrate:Fat:Prot / 20:60:20), acute study / one time administration
Arm Title
High fat challenge breakfast with mixed-spices
Arm Type
Experimental
Arm Description
High fat breakfast with mixed-spices (% Energy Carbohydrate:Fat:Prot / 20:60:20), acute study / one time administration
Intervention Type
Other
Intervention Name(s)
High fat challenge breakfast
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
High fat challenge breakfast with mixed-spices
Intervention Description
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
Primary Outcome Measure Information:
Title
Change from Baseline (0 hr) in untargeted PBMC gene expression profile at 4 hr
Description
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)
Time Frame
Prior to the initial intervention at 0 hr and after intervention at 4 hr
Secondary Outcome Measure Information:
Title
Postprandial appetite ratings after acute intervention
Description
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?
Time Frame
Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min.
Title
Postprandial gastrointestinal tolerance ratings after acute intervention
Description
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?
Time Frame
Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min.
Title
Postprandial blood glucose after acute intervention
Description
The capillary blood samples will be taken for blood glucose analysis.
Time Frame
Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min.
Title
Postprandial insulin after acute intervention
Description
The venous blood samples will be taken for insulin analysis. Insulin analysis will be conducted with routine hospital analysis at Labmedicine Skåne.
Time Frame
Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min.
Title
Postprandial triacylglycerol after acute intervention
Description
The venous blood samples will be taken for plasma triacylglycerol analysis. Plasma triacylglycerol analysis will be conducted with routine hospital analysis at Labmedicine Skåne.
Time Frame
Prior to the initial intervention at 0 min and after intervention at 30, 60, 90, 120, 180 and 240 min.
Title
Postprandial non-esterified fatty acids (NEFA) after acute intervention
Description
The venous blood samples will be taken for serum NEFA analysis. Serum NEFA analysis will be conducted with routine hospital analysis at Labmedicine Skåne.
Time Frame
Prior to the initial intervention at 0 min and after intervention at 30, 60, 90, 120, 180 and 240 min.
Title
Postprandial total cholesterol after acute intervention
Description
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.
Time Frame
Prior to the initial intervention at 0 min and after intervention at 30, 60, 90, 120, 180 and 240 min.
Title
Postprandial high density lipoprotein (HDL)-cholesterol after acute intervention
Description
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.
Time Frame
Prior to the initial intervention at 0 min and after intervention at 30, 60, 90, 120, 180 and 240 min.
Title
Postprandial low density lipoprotein (LDL)-cholesterol after acute intervention
Description
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.
Time Frame
Prior to the initial intervention at 0 min and after intervention at 30, 60, 90, 120, 180 and 240 min.
Title
Postprandial interleukin (IL)-6 after acute intervention
Description
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.
Time Frame
Prior to the initial intervention at 0 min and after intervention at 120 and 240 min.
Title
Postprandial interleukin (IL)-10 after acute intervention
Description
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.
Time Frame
Prior to the initial intervention at 0 min and after intervention at 120 and 240 min.
Title
Postprandial tumor necrosis factor (TNF)-alpha after acute intervention
Description
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.
Time Frame
Prior to the initial intervention at 0 min and after intervention at 120 and 240 min.
Title
Postprandial lipid peroxidation (MDA equivalent) after acute intervention
Description
The venous blood samples will be taken for lipid peroxidation (MDA) assay.
Time Frame
Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min.
Title
Postprandial total antioxidant capacity after acute intervention
Description
The venous blood samples will be taken for total antioxidant capacity (FRAP) assay.
Time Frame
Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min.
Title
Change from Baseline (0 hr) in untargeted circulating miRNA profile at 4 hr
Description
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)
Time Frame
Prior to the initial intervention at 0 hr and after intervention at 4 hr

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoghatama Cindya Zanzer, MSc PhDcand
Organizational Affiliation
Lund University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elin Östman, PhD A/Prof
Organizational Affiliation
Lund University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Congyu Xue, BSc
Organizational Affiliation
Lund University
Official's Role
Study Chair
Facility Information:
Facility Name
Food for Health Science Centre, Lund University
City
Lund
State/Province
Skåne
ZIP/Postal Code
22381
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
http://portal.research.lu.se/portal/sv/projects/antidiabetic-food-centre(3a9bae87-b64a-49f5-97a4-868a8bb776ae).html
Description
Antidiabetic Food Centre - VINNOVA Excellence Centre in Research and Innovation at Lund University, SWEDEN

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

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