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| Name | Class |
|---|---|
| Instituto De Frio | OTHER_GOV |
| University of Copenhagen | OTHER |
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AIMS:
The aims are to investigate whether:
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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood pressure from baseline to two weeks | Measured by a standard arm cuff by a trained bioanalyst | baseline to two weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in waist-to-hip circumference ratio | Measured manually by a trained bioanalyst | Change from baseline to two weeks |
| Change in fecal microbiota profile | RFLP of 16S cDNA |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars O Dragsted, PhD | Dep Nutrition, Exercise and Sports, University of Copenhagen | Principal Investigator |
| Susanne G Bügel, PhD | Dep Human Nutrition, LIFE, University of Copenhagen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dep. Human Nutrition, LIFE, University of Copenhagen | Frederiksberg C | 1958 | Denmark | |||
| Department of Nutrition, Exercise and Sports, University of Copenhagen |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| Placebo | Dietary Supplement | Hot meals without onion powder; Control meal with potato, beef, soy protein, and sucrose to match macronutrient composition of active treatment |
|
| change from baseline to two weeks |
| Change in total cholesterol | 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 | 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 | Triacylglycerides in plasma measured by an immunokit | change from baseline to 2, 4, and 24 hours and 2 weeks |
| Change in blood coagulation parameters | thromboelastography measurements, fibrinogen etc. in plasma | 0-4 hours |
| Change in whole-blood hematocrit | hematocrit by standard clinical chemistry | 0-14 days |
| Change in whole-blood haemoglobin concentration | haemoglobin concentration by standard clinical chemistry | 0-14 days |
| Change in body weight | Measured in triplicate on a calibrated balance | 0-14 days |
| Change in serum VCAM-1 | Determined with standard kits | 0-14 days |
| Change in serum IL-6 | Determined with standard kit | 0-14 days |
| Change in serum TNF-alpha | Determined with standard kit | 0-14 days |
| Change in faecal metabolic profiles | Untargeted metabolomics by LC-QTOF profiling of polar metabolites | 0-14 days |
| Change in faecal pH | pH by a pH-meter in a 50% aqueous fecal slurry | 0-14 days |
| Change in faecal bile acids | bile acids measured by LC-TQD | 0-14 days |
| Change in urine metabolomic profiles | Untargeted metabolomics by LC-QTOF profiling of polar metabolites | 0-14 days |
| Change in urine pH | pH by a pH-meter | 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. | 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. | 0-14 days |
| Change in HOMA | 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) | Change in ISI240 measured from 0-240 minutes after the first test meal. | 0-240 minutes |
| Change in erythrocyte Glutathione Reductase | Measured by automated colorimetric assays | 0-2 weeks |
| Change in erythrocyte superoxide dismutase | Measured by automated colorimetric assays | 0-2 weeks |
| Change in erythrocyte catalase | Measured by automated colorimetric assays | 0-2 weeks |
| Change in erythrocyte glutathione peroxidase | Measured by automated colorimetric assays | 0-2 weeks |
| Change in plasma untargeted metabolic profile | LC-QTOF profiling of polar metabolites and polar lipids | 0-2 weeks |
| Change from baseline in leucocyte gene expression profile | Selected genes by RT-PCR | 0, 2, 4 and 24 hours and 2 weeks |
| Frederiksberg C |
| 1958 |
| Denmark |