Onion, Cardiovascular Risk Markers and Gene Expression

NCT ID: NCT02449590

Last Updated: 2015-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2009-04-30

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)

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.

Conditions

Blood Pressure; Coagulation Delay

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Onion powder

Intervention Type: 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

Hot meals (1 potato soup and 1 meatball-meal daily)containing 8.5 g sucrose and 2 g soy protein instead of onion powder

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Instituto De Frio

OTHER_GOV

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: collaborator

Professor Lars Ove Dragsted

OTHER

Sponsor Role: lead

Responsible Party

Professor Lars Ove Dragsted

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lars O Dragsted, PhD

Role: PRINCIPAL_INVESTIGATOR

Dep Nutrition, Exercise and Sports, University of Copenhagen

Susanne G Bügel, PhD

Role: STUDY_DIRECTOR

Dep Human Nutrition, LIFE, University of Copenhagen

Locations

Dep. Human Nutrition, LIFE, University of Copenhagen

Frederiksberg C, , Denmark

Department of Nutrition, Exercise and Sports, University of Copenhagen

Frederiksberg C, , Denmark

Countries

Denmark

Other Identifiers

M197

Identifier Type: -

Identifier Source: org_study_id