Healthy
Conditions
Keywords
Spices, Functional food, Cardiometabolic risk, Metabolic syndrome, Inflammation, Peripheral blood mononuclear cell, Acute, miRNA
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.
Interventions
OTHERHigh 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
OTHERHigh 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
Sponsors
Anti-Diabetic Food Centre
Lund University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline (0 hr) in untargeted PBMC gene expression profile at 4 hr | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postprandial gastrointestinal tolerance ratings after acute intervention | 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? |
| Postprandial blood glucose after acute intervention | 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. |
| Postprandial insulin after acute intervention | 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. |
| Postprandial triacylglycerol after acute intervention | 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. |
| Postprandial non-esterified fatty acids (NEFA) after acute intervention | 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. |
| Postprandial total cholesterol after acute intervention | 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. |
| Postprandial high density lipoprotein (HDL)-cholesterol after acute intervention | 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. |
| Postprandial appetite ratings after acute intervention | 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? |
| Postprandial interleukin (IL)-6 after acute intervention | 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. |
| Postprandial interleukin (IL)-10 after acute intervention | 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. |
| Postprandial tumor necrosis factor (TNF)-alpha after acute intervention | 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. |
| Postprandial lipid peroxidation (MDA equivalent) after acute intervention | 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. |
| Postprandial total antioxidant capacity after acute intervention | 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. |
| Change from Baseline (0 hr) in untargeted circulating miRNA profile at 4 hr | 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) |
| Postprandial low density lipoprotein (LDL)-cholesterol after acute intervention | 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. |
Countries
Sweden
Outcome results
None listed