HealthyNCT02931643

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

A study testing High fat challenge breakfast and High fat challenge breakfast with mixed-spices in people with Healthy, run by Lund University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: High fat challenge breakfast and High fat challenge breakfast with mixed-spices
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 18 participants
Where: 1 siteSweden
Study dates: Oct 2016to Dec 2016
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy males and females
BMI 23-33 kg/m2
Must be able to accept spices
Agreed and signed informed consent

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Sweden1 site

Food for Health Science Centre, Lund University
Lund, Skåne County, 22381

Other trials in Sweden

About this study

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

Conditions: Healthy
Being tested: High fat challenge breakfast, High fat challenge breakfast with mixed-spices
Keywords: Spices, Functional food, Cardiometabolic risk, Metabolic syndrome, Inflammation, Peripheral blood mononuclear cell, Acute, miRNA
Medical subject headings: Metabolic Syndrome, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02931643
Study group	Role	What they receive
High fat challenge breakfast	Placebo comparator	High fat breakfast without mixed-spices (% Energy Carbohydrate:Fat:Prot / 20:60:20), acute study / one time administration Receives: Other: High fat challenge breakfast
High fat challenge breakfast with mixed-spices	Experimental	High fat breakfast with mixed-spices (% Energy Carbohydrate:Fat:Prot / 20:60:20), acute study / one time administration Receives: Other: High fat challenge breakfast with mixed-spices

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: Prior to the initial intervention at 0 hr and after intervention at 4 hr

Secondary outcomes (15)

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?
Measured: 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?
Measured: 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.
Measured: 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
The venous blood samples will be taken for insulin analysis. Insulin analysis will be conducted with routine hospital analysis at Labmedicine Skåne.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: Prior to the initial intervention at 0 hr and after intervention at 4 hr

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2016Dec 2016

First posted13 Oct 2016 (estimated)
Study startOct 2016
Primary completionNov 2016
Study completionDec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Lund UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02931643
Sponsor's protocol ID: LUND-AFCSTAGE4-SPICEMULTIOMICS
Status last verified: Oct 2016
First submitted: 11 Oct 2016
Last updated: 6 Jun 2018
Results posted: No
Data monitoring committee: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02931643
Acronym / sponsor ID: LUND-AFCSTAGE4-SPICEMULTIOMICS
Conditions: Healthy
Keywords: Spices, Functional food, Cardiometabolic risk, Metabolic syndrome, Inflammation, Peripheral blood mononuclear cell, Acute, miRNA
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Lund UniversityUniversity, hospital or other
Collaborators: Anti-Diabetic Food Centre
Study start: Oct 2016 (actual)
Primary completion: Nov 2016 (actual)
Study completion: Dec 2016 (actual)
First posted: 13 Oct 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
High fat challenge breakfast	Placebo comparator	Other: High fat challenge breakfastHigh fat breakfast without mixed-spices (% Energy Carbohydrate:Fat:Prot / 20:60:20), acute study / one time administration
High fat challenge breakfast with mixed-spices	Experimental	Other: High fat challenge breakfast with mixed-spicesHigh fat breakfast with mixed-spices (% Energy Carbohydrate:Fat:Prot / 20:60:20), acute study / one time administration

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Healthy males and females
BMI 23-33 kg/m2
Must be able to accept spices
Agreed and signed informed consent

Key exclusion criteria (8 listed)

Below 18 years old
Uncomfortable speaking English and/or difficulties in understanding spoken English
Smoking or using snuss
Vegetarian or vegan
Having food allergies

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
High fat challenge breakfastIn 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	Other	High fat challenge breakfast
High fat challenge breakfast with mixed-spicesIn 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	Other	High fat challenge breakfast with mixed-spices

Primary outcome

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)

15 secondary outcomes

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 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 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 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 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 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 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.
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 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 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 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 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 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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
Antidiabetic Food Centre - VINNOVA Excellence Centre in Research and Innovation at Lund University, SWEDENLink provided by the sponsor.
Individual participant dataSharing planned: Undecided

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A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yoghatama Cindya Zanzer, MSc PhDcand principal investigator

Lund University

Elin Östman, PhD A/Prof principal investigator

Lund University

Congyu Xue, BSc study chair

Lund University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing High fat challenge breakfast and High fat challenge breakfast with mixed-spices in people with Healthy, run by Lund University at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02931643.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2018.