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OpenTrials
Completed

NCT Number: NCT02449590

Onion, Cardiovascular Risk Markers and Gene Expression

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)

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dep. Human Nutrition, LIFE, University of Copenhagen, Frederiksberg C, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Onion powder

Dietary 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.

Placebo

Dietary Supplement

Hot meals without onion powder; Control meal with potato, beef, soy protein, and sucrose to match macronutrient composition of active treatment

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Professor Lars Ove Dragsted

Other

Collaborators

  • Instituto De Frio
  • University of Copenhagen

Registry information

Official study title

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

Acronym: M197

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
May 20, 2015
Registry last updated
May 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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