Onion, Cardiovascular Risk Markers and Gene Expression (M197)

May 19, 2015 updated by: Professor Lars Ove Dragsted

The Effects of Onion on Plasma Lipoproteins, Blood Pressure and Gene Expression in Overweight Humans - a Double-blinded, Randomized Cross-over Study

AIMS:

The aims are to investigate whether:

  • Increased intake of onion (powder) affects plasma lipid profile, blood pressure, indices of insulin sensitivity and blood coagulation.
  • Increased intake of onion (powder) affects the expression/activity of enzymes in the defence against foreign substances, e.g. reactive oxygen species, and whether polymorphisms in some of the involved genes may modulate the effect.
  • Polymorphisms involved in the metabolism/effect of bioactive components in onion modulate the excretion of metabolites or modulate some of the outcome variables in the study.

Other aims are to try to identify biomarkers for onion consumption in plasma, urine and feces and to investigate whether onion affects the secretion of fat and bile acids.

HYPOTHESES:

The investigators hypothesize that:

  • 2 weeks of increased onion intake will improve the plasma lipid profile
  • 2 weeks of increased onion intake will increase the metabolism of potentially harmful substances (such as ROS and free radicals) through a change in the expression or activity of certain enzymes.
  • That these effects are modulated by common gene variants (polymorphisms)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In a randomized controlled crossover design, participants will receive 2 daily meals with or without onion powder for 2 weeks. Between the two 2-week period is a 4-week wash-out period. One week before and during each intervention period, the participants will be instructed to avoid consumption of onion, garlic and all foodstuffs containing the same bioactive components (polyphenols, sulfur-molecules)as in onion. This includes a number of vegetables and fruits, condiments, tea, chocolate, red wine etc.

Fasting blood samples will be drawn before and after (on 2 separate days) each intervention period, where also weight and blood pressure are measured.

Participants will collect 24-hour urine and feces samples twice before and at completion of each intervention period.

After the fasting blood sampling on the first blood sampling day in each period, participants will receive a test meal (with 10 g onion powder or placebo, i.e. 8.5 g sucrose+ 2 g soy protein isolate). The acute effects will be studied by blood sampling and urine sampling 0, 2, 4 and 24 hours after the test meal.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Frederiksberg C, Denmark, 1958
        • Department of Nutrition, Exercise and sports, University of Copenhagen
      • Frederiksberg C, Denmark, 1958
        • Dep. Human Nutrition, LIFE, University of Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy
  • BMI 25-40
  • No daily medication (except thyroid hormone, stomach acid lowering drugs, mild blood pressure lowering drugs and anti-depressants)
  • Not strenuous exercise >10 hours/week
  • No blood donation 3 months before or during the study

Exclusion Criteria:

  • Diabetes, CVD, hepatitis, HIV/AIDS
  • Cancer or cancer treatment within last 6 months
  • Smoking
  • Simultaneous participation in other research projects

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Onion powder
Initial test meal contained 20g freeze dried onion powder in hot meals (1 potato soup and 1 meatball-meal daily). Subsequent daily meals contained 20g onion powder in the same meal formats.
Dietary supplement: Onion powder
Hot meals with onion powder; 10 g/day onion powder corresponding to 100 g/day fresh onion in meals with potato and beef Intervention period 14 days.
Placebo Comparator: Placebo
Hot meals (1 potato soup and 1 meatball-meal daily)containing 8.5 g sucrose and 2 g soy protein instead of onion powder
Dietary supplement: Placebo
Hot meals without onion powder; Control meal with potato, beef, soy protein, and sucrose to match macronutrient composition of active treatment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in blood pressure from baseline to two weeks
Time Frame: baseline to two weeks
Measured by a standard arm cuff by a trained bioanalyst
baseline to two weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in waist-to-hip circumference ratio
Time Frame: Change from baseline to two weeks
Measured manually by a trained bioanalyst
Change from baseline to two weeks
Change in fecal microbiota profile
Time Frame: change from baseline to two weeks
RFLP of 16S cDNA
change from baseline to two weeks
Change in total cholesterol
Time Frame: change from baseline to 2, 4, and 24 hours and 2 weeks
Total plasma cholesterol in lipoproteins measured by a clinical chemistry kit
change from baseline to 2, 4, and 24 hours and 2 weeks
Change in HDL cholesterol
Time Frame: change from baseline to 2, 4, and 24 hours and 2 weeks
High density Lipoprotein Cholesterol in plasma measured by an immunokit
change from baseline to 2, 4, and 24 hours and 2 weeks
Change in plasma triacylglycerides
Time Frame: change from baseline to 2, 4, and 24 hours and 2 weeks
Triacylglycerides in plasma measured by an immunokit
change from baseline to 2, 4, and 24 hours and 2 weeks
Change in blood coagulation parameters
Time Frame: 0-4 hours
thromboelastography measurements, fibrinogen etc. in plasma
0-4 hours
Change in whole-blood hematocrit
Time Frame: 0-14 days
hematocrit by standard clinical chemistry
0-14 days
Change in whole-blood haemoglobin concentration
Time Frame: 0-14 days
haemoglobin concentration by standard clinical chemistry
0-14 days
Change in body weight
Time Frame: 0-14 days
Measured in triplicate on a calibrated balance
0-14 days
Change in serum VCAM-1
Time Frame: 0-14 days
Determined with standard kits
0-14 days
Change in serum IL-6
Time Frame: 0-14 days
Determined with standard kit
0-14 days
Change in serum TNF-alpha
Time Frame: 0-14 days
Determined with standard kit
0-14 days
Change in faecal metabolic profiles
Time Frame: 0-14 days
Untargeted metabolomics by LC-QTOF profiling of polar metabolites
0-14 days
Change in faecal pH
Time Frame: 0-14 days
pH by a pH-meter in a 50% aqueous fecal slurry
0-14 days
Change in faecal bile acids
Time Frame: 0-14 days
bile acids measured by LC-TQD
0-14 days
Change in urine metabolomic profiles
Time Frame: 0-14 days
Untargeted metabolomics by LC-QTOF profiling of polar metabolites
0-14 days
Change in urine pH
Time Frame: 0-14 days
pH by a pH-meter
0-14 days
Change in plasma insulin (multivariate ANOVA)
Time Frame: 0-14 days
Insulin measured at baseline before meals and at 2, 4 and 24 hours, 2, 7 and 14 days after the start of intervention.
0-14 days
Change in plasma glucose (multivariate ANOVA)
Time Frame: 0-14 days
Glucose measured at baseline before meals and at 2, 4 and 24 hours, 2, 7 and 14 days after the start of intervention.
0-14 days
Change in HOMA
Time Frame: 0-14 days
Change in HOMA measured at baseline before meals and at 14 days after the start of intervention.
0-14 days
Change in ISI240 (Matsuda insulin sensitivity index 0-240)
Time Frame: 0-240 minutes
Change in ISI240 measured from 0-240 minutes after the first test meal.
0-240 minutes
Change in erythrocyte Glutathione Reductase
Time Frame: 0-2 weeks
Measured by automated colorimetric assays
0-2 weeks
Change in erythrocyte superoxide dismutase
Time Frame: 0-2 weeks
Measured by automated colorimetric assays
0-2 weeks
Change in erythrocyte catalase
Time Frame: 0-2 weeks
Measured by automated colorimetric assays
0-2 weeks
Change in erythrocyte glutathione peroxidase
Time Frame: 0-2 weeks
Measured by automated colorimetric assays
0-2 weeks
Change in plasma untargeted metabolic profile
Time Frame: 0-2 weeks
LC-QTOF profiling of polar metabolites and polar lipids
0-2 weeks
Change from baseline in leucocyte gene expression profile
Time Frame: 0, 2, 4 and 24 hours and 2 weeks
Selected genes by RT-PCR
0, 2, 4 and 24 hours and 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Professor Lars Ove Dragsted

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Copenhagen
Instituto De Frio

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lars O Dragsted, PhD, Dep Nutrition, Exercise and Sports, University of Copenhagen
  • Study Director: Susanne G Bügel, PhD, Dep Human Nutrition, LIFE, University of Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 8, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 20, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 20, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M197

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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