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Onion, Cardiovascular Risk Markers and Gene Expression (M197)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02449590
Recruitment Status : Completed
First Posted : May 20, 2015
Last Update Posted : May 20, 2015
Sponsor:
Collaborators:
Instituto De Frio
University of Copenhagen
Information provided by (Responsible Party):
Professor Lars Ove Dragsted, University of Copenhagen

Brief 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. 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)

Condition or disease Intervention/treatment Phase
Blood Pressure Coagulation Delay Dietary Supplement: Onion powder Dietary Supplement: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effects of Onion on Plasma Lipoproteins, Blood Pressure and Gene Expression in Overweight Humans - a Double-blinded, Randomized Cross-over Study
Study Start Date : August 2008
Actual Primary Completion Date : November 2008
Actual Study Completion Date : April 2009


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Change in waist-to-hip circumference ratio [ Time Frame: Change from baseline to two weeks ]
    Measured manually by a trained bioanalyst

  2. Change in fecal microbiota profile [ Time Frame: change from baseline to two weeks ]
    RFLP of 16S cDNA

  3. 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

  4. 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

  5. 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

  6. Change in blood coagulation parameters [ Time Frame: 0-4 hours ]
    thromboelastography measurements, fibrinogen etc. in plasma

  7. Change in whole-blood hematocrit [ Time Frame: 0-14 days ]
    hematocrit by standard clinical chemistry

  8. Change in whole-blood haemoglobin concentration [ Time Frame: 0-14 days ]
    haemoglobin concentration by standard clinical chemistry

  9. Change in body weight [ Time Frame: 0-14 days ]
    Measured in triplicate on a calibrated balance

  10. Change in serum VCAM-1 [ Time Frame: 0-14 days ]
    Determined with standard kits

  11. Change in serum IL-6 [ Time Frame: 0-14 days ]
    Determined with standard kit

  12. Change in serum TNF-alpha [ Time Frame: 0-14 days ]
    Determined with standard kit

  13. Change in faecal metabolic profiles [ Time Frame: 0-14 days ]
    Untargeted metabolomics by LC-QTOF profiling of polar metabolites

  14. Change in faecal pH [ Time Frame: 0-14 days ]
    pH by a pH-meter in a 50% aqueous fecal slurry

  15. Change in faecal bile acids [ Time Frame: 0-14 days ]
    bile acids measured by LC-TQD

  16. Change in urine metabolomic profiles [ Time Frame: 0-14 days ]
    Untargeted metabolomics by LC-QTOF profiling of polar metabolites

  17. Change in urine pH [ Time Frame: 0-14 days ]
    pH by a pH-meter

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. Change in erythrocyte Glutathione Reductase [ Time Frame: 0-2 weeks ]
    Measured by automated colorimetric assays

  23. Change in erythrocyte superoxide dismutase [ Time Frame: 0-2 weeks ]
    Measured by automated colorimetric assays

  24. Change in erythrocyte catalase [ Time Frame: 0-2 weeks ]
    Measured by automated colorimetric assays

  25. Change in erythrocyte glutathione peroxidase [ Time Frame: 0-2 weeks ]
    Measured by automated colorimetric assays

  26. Change in plasma untargeted metabolic profile [ Time Frame: 0-2 weeks ]
    LC-QTOF profiling of polar metabolites and polar lipids

  27. Change from baseline in leucocyte gene expression profile [ Time Frame: 0, 2, 4 and 24 hours and 2 weeks ]
    Selected genes by RT-PCR



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02449590


Locations
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Denmark
Dep. Human Nutrition, LIFE, University of Copenhagen
Frederiksberg C, Denmark, 1958
Department of Nutrition, Exercise and Sports, University of Copenhagen
Frederiksberg C, Denmark, 1958
Sponsors and Collaborators
Professor Lars Ove Dragsted
Instituto De Frio
University of Copenhagen
Investigators
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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
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Responsible Party: Professor Lars Ove Dragsted, Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT02449590    
Other Study ID Numbers: M197
First Posted: May 20, 2015    Key Record Dates
Last Update Posted: May 20, 2015
Last Verified: May 2015
Keywords provided by Professor Lars Ove Dragsted, University of Copenhagen:
Onion
Cardiovascular disease
metabolomics
Gene expression
Biomarker