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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02931643
Date of registration: 11/10/2016
Prospective Registration: No
Primary sponsor: Lund University
Public title: Postprandial Effects of Mixed Herbs and Spices on Pathways Associated With Glucose Homeostasis and Inflammation on PBMCs of Healthy Subjects
Scientific 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
Date of first enrolment: October 2016
Target sample size: 18
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02931643
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: Single (Participant).  
Phase:  N/A
Countries of recruitment
Sweden
Contacts
Name:     Congyu Xue, BSc
Address: 
Telephone:
Email:
Affiliation:  Lund University
Name:     Elin Östman, PhD A/Prof
Address: 
Telephone:
Email:
Affiliation:  Lund University
Name:     Yoghatama Cindya Zanzer, MSc PhDcand
Address: 
Telephone:
Email:
Affiliation:  Lund University
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 40 Years
Gender: All
Health Condition(s) or Problem(s) studied
Healthy
Intervention(s)
Other: High fat challenge breakfast
Other: High fat challenge breakfast with mixed-spices
Primary Outcome(s)
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]
Secondary Outcome(s)
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.]
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.]
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.]
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.]
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.]
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.]
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]
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.]
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.]
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.]
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.]
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.]
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.]
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.]
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.]
Secondary ID(s)
LUND-AFCSTAGE4-SPICEMULTIOMICS
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Anti-Diabetic Food Centre
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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