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

Lund University18 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Healthy

Interventions

High fat challenge breakfastOTHER

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-spicesOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Food for Health Science Centre, Lund University

Lund, Skåne County, Sweden

Outcomes

Primary Outcomes

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)

Time frame: Prior to the initial intervention at 0 hr and after intervention at 4 hr

Secondary Outcomes

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?

Time frame: 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

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.

Postprandial blood glucose after acute intervention

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.

Data from ClinicalTrials.gov

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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.

Time frame: 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

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.

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.

Time frame: 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

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.

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.

Time frame: 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

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.

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.

Time frame: Prior to the initial intervention at 0 min and after intervention at 120 and 240 min.

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.

Time frame: 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

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.

Postprandial lipid peroxidation (MDA equivalent) after acute intervention

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.

Postprandial total antioxidant capacity after acute intervention

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.

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)

Time frame: Prior to the initial intervention at 0 hr and after intervention at 4 hr