Onion powder
Dietary SupplementHot 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.
NCT Number: NCT02449590
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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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Dep. Human Nutrition, LIFE, University of Copenhagen, Frederiksberg C, Denmark
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Hot meals without onion powder; Control meal with potato, beef, soy protein, and sucrose to match macronutrient composition of active treatment
Time frame: baseline to two weeks
Measured by a standard arm cuff by a trained bioanalyst
Time frame: Change from baseline to two weeks
Measured manually by a trained bioanalyst
Time frame: change from baseline to two weeks
RFLP of 16S cDNA
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
Time frame: change from baseline to 2, 4, and 24 hours and 2 weeks
High density Lipoprotein Cholesterol in plasma measured by an immunokit
Time frame: change from baseline to 2, 4, and 24 hours and 2 weeks
Triacylglycerides in plasma measured by an immunokit
Time frame: 0-4 hours
thromboelastography measurements, fibrinogen etc. in plasma
Time frame: 0-14 days
hematocrit by standard clinical chemistry
Time frame: 0-14 days
haemoglobin concentration by standard clinical chemistry
Time frame: 0-14 days
Measured in triplicate on a calibrated balance
Time frame: 0-14 days
Determined with standard kits
Time frame: 0-14 days
Determined with standard kit
Time frame: 0-14 days
Determined with standard kit
Time frame: 0-14 days
Untargeted metabolomics by LC-QTOF profiling of polar metabolites
Time frame: 0-14 days
pH by a pH-meter in a 50% aqueous fecal slurry
Time frame: 0-14 days
bile acids measured by LC-TQD
Time frame: 0-14 days
Untargeted metabolomics by LC-QTOF profiling of polar metabolites
Time frame: 0-14 days
pH by a pH-meter
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.
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.
Time frame: 0-14 days
Change in HOMA measured at baseline before meals and at 14 days after the start of intervention.
Time frame: 0-240 minutes
Change in ISI240 measured from 0-240 minutes after the first test meal.
Time frame: 0-2 weeks
Measured by automated colorimetric assays
Time frame: 0-2 weeks
Measured by automated colorimetric assays
Time frame: 0-2 weeks
Measured by automated colorimetric assays
Time frame: 0-2 weeks
Measured by automated colorimetric assays
Time frame: 0-2 weeks
LC-QTOF profiling of polar metabolites and polar lipids
Time frame: 0, 2, 4 and 24 hours and 2 weeks
Selected genes by RT-PCR
Professor Lars Ove Dragsted
Other
The Effects of Onion on Plasma Lipoproteins, Blood Pressure and Gene Expression in Overweight Humans - a Double-blinded, Randomized Cross-over Study
Acronym: M197
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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