Blood PressureM197NCT02449590
Onion, Cardiovascular Risk Markers and Gene Expression
A study testing Onion powder in people with Blood Pressure and Coagulation Delay, run by Professor Lars Ove Dragsted at 2 sites in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Coagulation Delay
- What is being tested?
- Onion powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 2 sitesDenmark
- Study dates
- Aug 2008to Apr 2009
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Diabetes, CVD, hepatitis, HIV/AIDS
- Cancer or cancer treatment within last 6 months
- Smoking
- Simultaneous participation in other research projects
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Dep. Human Nutrition, LIFE, University of Copenhagen
Frederiksberg C, 1958
Department of Nutrition, Exercise and Sports, University of Copenhagen
Frederiksberg C, 1958
About this study
Official title: 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:
Read more
- 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)
Read the 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.
- Conditions
- Blood Pressure, Coagulation Delay
- Being tested
- Onion powder, Placebo
- Keywords
- Onion, Cardiovascular disease, metabolomics, Gene expression, Biomarker
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Onion powderDietary supplement
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.
PlaceboDietary supplement
Hot meals without onion powder; Control meal with potato, beef, soy protein, and sucrose to match macronutrient composition of active treatment
| Study group | Role | What they receive |
|---|---|---|
| Onion powder | Active comparator | 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. Receives: Dietary Supplement: Onion powder |
| Placebo | Placebo comparator | Hot meals (1 potato soup and 1 meatball-meal daily)containing 8.5 g sucrose and 2 g soy protein instead of onion powder Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood pressure from baseline to two weeks
Measured by a standard arm cuff by a trained bioanalyst
Measured: baseline to two weeks
Secondary outcomes (27)
Change in waist-to-hip circumference ratio
Measured manually by a trained bioanalyst
Measured: Change from baseline to two weeks
Change in fecal microbiota profile
RFLP of 16S cDNA
Measured: change from baseline to two weeks
Change in total cholesterol
Total plasma cholesterol in lipoproteins measured by a clinical chemistry kit
Measured: change from baseline to 2, 4, and 24 hours and 2 weeks
Change in HDL cholesterol
High density Lipoprotein Cholesterol in plasma measured by an immunokit
Measured: change from baseline to 2, 4, and 24 hours and 2 weeks
Change in plasma triacylglycerides
Triacylglycerides in plasma measured by an immunokit
Measured: change from baseline to 2, 4, and 24 hours and 2 weeks
Change in blood coagulation parameters
thromboelastography measurements, fibrinogen etc. in plasma
Measured: 0-4 hours
Change in whole-blood hematocrit
hematocrit by standard clinical chemistry
Measured: 0-14 days
Change in whole-blood haemoglobin concentration
haemoglobin concentration by standard clinical chemistry
Measured: 0-14 days
Change in body weight
Measured in triplicate on a calibrated balance
Measured: 0-14 days
Change in serum VCAM-1
Determined with standard kits
Measured: 0-14 days
Change in serum IL-6
Determined with standard kit
Measured: 0-14 days
Change in serum TNF-alpha
Determined with standard kit
Measured: 0-14 days
Change in faecal metabolic profiles
Untargeted metabolomics by LC-QTOF profiling of polar metabolites
Measured: 0-14 days
Change in faecal pH
pH by a pH-meter in a 50% aqueous fecal slurry
Measured: 0-14 days
Change in faecal bile acids
bile acids measured by LC-TQD
Measured: 0-14 days
Change in urine metabolomic profiles
Untargeted metabolomics by LC-QTOF profiling of polar metabolites
Measured: 0-14 days
Change in urine pH
pH by a pH-meter
Measured: 0-14 days
Change in plasma insulin (multivariate ANOVA)
Insulin measured at baseline before meals and at 2, 4 and 24 hours, 2, 7 and 14 days after the start of intervention.
Measured: 0-14 days
Change in plasma glucose (multivariate ANOVA)
Glucose measured at baseline before meals and at 2, 4 and 24 hours, 2, 7 and 14 days after the start of intervention.
Measured: 0-14 days
Change in HOMA
Change in HOMA measured at baseline before meals and at 14 days after the start of intervention.
Measured: 0-14 days
Change in ISI240 (Matsuda insulin sensitivity index 0-240)
Change in ISI240 measured from 0-240 minutes after the first test meal.
Measured: 0-240 minutes
Change in erythrocyte Glutathione Reductase
Measured by automated colorimetric assays
Measured: 0-2 weeks
Change in erythrocyte superoxide dismutase
Measured by automated colorimetric assays
Measured: 0-2 weeks
Change in erythrocyte catalase
Measured by automated colorimetric assays
Measured: 0-2 weeks
Change in erythrocyte glutathione peroxidase
Measured by automated colorimetric assays
Measured: 0-2 weeks
Change in plasma untargeted metabolic profile
LC-QTOF profiling of polar metabolites and polar lipids
Measured: 0-2 weeks
Change from baseline in leucocyte gene expression profile
Selected genes by RT-PCR
Measured: 0, 2, 4 and 24 hours and 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2015 (estimated)
- Study startAug 2008
- Primary completionNov 2008
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Professor Lars Ove Dragsted
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto De Frio, University of Copenhagen
- Responsible party
- Sponsor-investigator, Professor Lars Ove Dragsted, University of Copenhagen
- Investigators
- Lars O Dragsted, PhD, Principal investigator, Dep Nutrition, Exercise and Sports, University of CopenhagenSusanne G Bügel, PhD, Study director, Dep Human Nutrition, LIFE, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02449590
- Sponsor's protocol ID
- M197
- Acronym
- M197
- Status last verified
- May 2015
- First submitted
- 8 Feb 2015
- Last updated
- 20 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Onion on Plasma Lipoproteins, Blood Pressure and Gene Expression in Overweight Humans - a Double-blinded, Randomized Cross-over Study
- ClinicalTrials.gov ID
- NCT02449590
- Acronym / sponsor ID
- M197 / M197
- Conditions
- Blood Pressure, Coagulation Delay
- Keywords
- Onion, Cardiovascular disease, metabolomics, Gene expression, Biomarker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Professor Lars Ove DragstedUniversity, hospital or other
- Collaborators
- Instituto De Frio, University of Copenhagen
- Study start
- Aug 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 20 May 2015 (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.
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)
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Onion powder | Active comparator | Dietary Supplement: Onion powderInitial 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. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboHot meals (1 potato soup and 1 meatball-meal daily)containing 8.5 g sucrose and 2 g soy protein instead of onion powder |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Diabetes, CVD, hepatitis, HIV/AIDS
- Cancer or cancer treatment within last 6 months
- Smoking
- Simultaneous participation in other research projects
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 |
|---|---|---|
| Onion powderHot 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. | Dietary supplement | Onion powder |
| PlaceboHot meals without onion powder; Control meal with potato, beef, soy protein, and sucrose to match macronutrient composition of active treatment | Dietary supplement | Placebo |
Primary outcome
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
27 secondary outcomes
Change in waist-to-hip circumference ratio
Time frame: Change from baseline to two weeks
Change in fecal microbiota profile
Time frame: change from baseline to two weeks
Change in total cholesterol
Time frame: 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
Change in plasma triacylglycerides
Time frame: change from baseline to 2, 4, and 24 hours and 2 weeks
Change in blood coagulation parameters
Time frame: 0-4 hours
Change in whole-blood hematocrit
Time frame: 0-14 days
Change in whole-blood haemoglobin concentration
Time frame: 0-14 days
Change in body weight
Time frame: 0-14 days
Change in serum VCAM-1
Time frame: 0-14 days
Change in serum IL-6
Time frame: 0-14 days
Change in serum TNF-alpha
Time frame: 0-14 days
Change in faecal metabolic profiles
Time frame: 0-14 days
Change in faecal pH
Time frame: 0-14 days
Change in faecal bile acids
Time frame: 0-14 days
Change in urine metabolomic profiles
Time frame: 0-14 days
Change in urine pH
Time frame: 0-14 days
Change in plasma insulin (multivariate ANOVA)
Time frame: 0-14 days
Change in plasma glucose (multivariate ANOVA)
Time frame: 0-14 days
Change in HOMA
Time frame: 0-14 days
Change in ISI240 (Matsuda insulin sensitivity index 0-240)
Time frame: 0-240 minutes
Change in erythrocyte Glutathione Reductase
Time frame: 0-2 weeks
Change in erythrocyte superoxide dismutase
Time frame: 0-2 weeks
Change in erythrocyte catalase
Time frame: 0-2 weeks
Change in erythrocyte glutathione peroxidase
Time frame: 0-2 weeks
Change in plasma untargeted metabolic profile
Time frame: 0-2 weeks
Change from baseline in leucocyte gene expression profile
Time frame: 0, 2, 4 and 24 hours and 2 weeks
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 20 May 2015.
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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.
Lars O Dragsted, PhD principal investigator
Dep Nutrition, Exercise and Sports, University of Copenhagen
Susanne G Bügel, PhD study director
Dep Human Nutrition, LIFE, University of Copenhagen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Onion powder in people with Blood Pressure and Coagulation Delay, run by Professor Lars Ove Dragsted at 2 sites in Denmark.
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 5 inclusion and 4 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 20 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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 in blood pressure from baseline to two weeks (time frame: baseline to two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 May 2015.