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Completed

NCT Number: NCT02931643

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

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.

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Key information

Conditions

Healthy Glucose Metabolism Disorders Hyperinsulinism Inflammation Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Food for Health Science Centre, Lund University

Lund, Skåne County, 22381, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High fat challenge breakfast

Other

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

Other

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 outcomes

  1. 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)

Secondary outcomes

  1. 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?

  2. 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?

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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)

Sponsors and collaborators

Lead sponsor

Lund University

Other

Collaborators

  • Anti-Diabetic Food Centre

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Oct 13, 2016
Registry last updated
Jun 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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