Onion, Cardiovascular Risk Markers and Gene Expression

Blood Pressure Clinical Trial

— M197  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02449590
• Other study ID #: M197
• Status: Completed
• Phase: N/A
• First received: February 8, 2015
• Last updated: May 19, 2015
• Start date: August 2008
• Est. completion date: April 2009

Study information

• Verified date: May 2015
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical 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. 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Blood Pressure
• Coagulation Delay

Intervention

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

Locations

Country	Name	City	State
Denmark	Dep. Human Nutrition, LIFE, University of Copenhagen	Frederiksberg C
Denmark	Department of Nutrition, Exercise and Sports, University of Copenhagen	Frederiksberg C

Sponsors (3)

Lead Sponsor	Collaborator
Professor Lars Ove Dragsted	Instituto De Frio, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in blood pressure from baseline to two weeks	Measured by a standard arm cuff by a trained bioanalyst	baseline to two weeks	No
Secondary	Change in waist-to-hip circumference ratio	Measured manually by a trained bioanalyst	Change from baseline to two weeks	No
Secondary	Change in fecal microbiota profile	RFLP of 16S cDNA	change from baseline to two weeks	No
Secondary	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	No
Secondary	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	No
Secondary	Change in plasma triacylglycerides	Triacylglycerides in plasma measured by an immunokit	change from baseline to 2, 4, and 24 hours and 2 weeks	No
Secondary	Change in blood coagulation parameters	thromboelastography measurements, fibrinogen etc. in plasma	0-4 hours	No
Secondary	Change in whole-blood hematocrit	hematocrit by standard clinical chemistry	0-14 days	No
Secondary	Change in whole-blood haemoglobin concentration	haemoglobin concentration by standard clinical chemistry	0-14 days	No
Secondary	Change in body weight	Measured in triplicate on a calibrated balance	0-14 days	No
Secondary	Change in serum VCAM-1	Determined with standard kits	0-14 days	No
Secondary	Change in serum IL-6	Determined with standard kit	0-14 days	No
Secondary	Change in serum TNF-alpha	Determined with standard kit	0-14 days	No
Secondary	Change in faecal metabolic profiles	Untargeted metabolomics by LC-QTOF profiling of polar metabolites	0-14 days	No
Secondary	Change in faecal pH	pH by a pH-meter in a 50% aqueous fecal slurry	0-14 days	No
Secondary	Change in faecal bile acids	bile acids measured by LC-TQD	0-14 days	No
Secondary	Change in urine metabolomic profiles	Untargeted metabolomics by LC-QTOF profiling of polar metabolites	0-14 days	No
Secondary	Change in urine pH	pH by a pH-meter	0-14 days	No
Secondary	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	No
Secondary	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	No
Secondary	Change in HOMA	Change in HOMA measured at baseline before meals and at 14 days after the start of intervention.	0-14 days	No
Secondary	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	No
Secondary	Change in erythrocyte Glutathione Reductase	Measured by automated colorimetric assays	0-2 weeks	No
Secondary	Change in erythrocyte superoxide dismutase	Measured by automated colorimetric assays	0-2 weeks	No
Secondary	Change in erythrocyte catalase	Measured by automated colorimetric assays	0-2 weeks	No
Secondary	Change in erythrocyte glutathione peroxidase	Measured by automated colorimetric assays	0-2 weeks	No
Secondary	Change in plasma untargeted metabolic profile	LC-QTOF profiling of polar metabolites and polar lipids	0-2 weeks	No
Secondary	Change from baseline in leucocyte gene expression profile	Selected genes by RT-PCR	0, 2, 4 and 24 hours and 2 weeks	No