Clinical trial NCT02931643: 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
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Spices
Functional food
Cardiometabolic risk
Metabolic syndrome
Inflammation
Peripheral blood mononuclear cell
Acute
miRNA
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: Anti-Diabetic Food Centre
First posted: 2016-10-13
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Change from Baseline (0 hr) in untargeted PBMC gene expression profile at 4 hr
timeFrame: Prior to the initial intervention at 0 hr and after intervention at 4 hr
Secondary outcomes:
measure: Postprandial appetite ratings after acute intervention
timeFrame: Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min.
measure: Postprandial gastrointestinal tolerance ratings after acute intervention
timeFrame: Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min.
measure: Postprandial blood glucose after acute intervention
timeFrame: Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min.
measure: Postprandial insulin after acute intervention
timeFrame: Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min.
measure: Postprandial triacylglycerol after acute intervention
timeFrame: Prior to the initial intervention at 0 min and after intervention at 30, 60, 90, 120, 180 and 240 min.
measure: Postprandial non-esterified fatty acids (NEFA) after acute intervention
timeFrame: Prior to the initial intervention at 0 min and after intervention at 30, 60, 90, 120, 180 and 240 min.
measure: Postprandial total cholesterol after acute intervention
timeFrame: Prior to the initial intervention at 0 min and after intervention at 30, 60, 90, 120, 180 and 240 min.
measure: Postprandial high density lipoprotein (HDL)-cholesterol after acute intervention
timeFrame: Prior to the initial intervention at 0 min and after intervention at 30, 60, 90, 120, 180 and 240 min.
measure: Postprandial low density lipoprotein (LDL)-cholesterol after acute intervention
timeFrame: Prior to the initial intervention at 0 min and after intervention at 30, 60, 90, 120, 180 and 240 min.
measure: Postprandial interleukin (IL)-6 after acute intervention
timeFrame: Prior to the initial intervention at 0 min and after intervention at 120 and 240 min.
measure: Postprandial interleukin (IL)-10 after acute intervention
timeFrame: Prior to the initial intervention at 0 min and after intervention at 120 and 240 min.
measure: Postprandial tumor necrosis factor (TNF)-alpha after acute intervention
timeFrame: Prior to the initial intervention at 0 min and after intervention at 120 and 240 min.
measure: Postprandial lipid peroxidation (MDA equivalent) after acute intervention
timeFrame: Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min.
measure: Postprandial total antioxidant capacity after acute intervention
timeFrame: Prior to the initial intervention at 0 min and after intervention at 15, 30, 45, 60, 90, 120, 180 and 240 min.
measure: Change from Baseline (0 hr) in untargeted circulating miRNA profile at 4 hr
timeFrame: Prior to the initial intervention at 0 hr and after intervention at 4 hr
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Food for Health Science Centre, Lund University
state: Skåne
Study officials:
affiliation: Lund University
name: Yoghatama Cindya Zanzer, MSc PhDcand
role: PRINCIPAL_INVESTIGATOR
affiliation: Lund University
name: Elin Östman, PhD A/Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Lund University
name: Congyu Xue, BSc
role: STUDY_CHAIR
References: