NCT02449590

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

February 8, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 20, 2015

Completed
Last Updated

May 20, 2015

Status Verified

May 1, 2015

Enrollment Period

3 months

First QC Date

February 8, 2015

Last Update Submit

May 19, 2015

Conditions

Blood PressureCoagulation Delay

Keywords

OnionCardiovascular diseasemetabolomicsGene expressionBiomarker

Outcome Measures

Primary Outcomes (1)

  • Change in blood pressure from baseline to two weeks

    Measured by a standard arm cuff by a trained bioanalyst

    baseline to two weeks

Secondary Outcomes (27)

  • Change in waist-to-hip circumference ratio

    Change from baseline to two weeks

  • Change in fecal microbiota profile

    change from baseline to two weeks

  • Change in total cholesterol

    change from baseline to 2, 4, and 24 hours and 2 weeks

  • Change in HDL cholesterol

    change from baseline to 2, 4, and 24 hours and 2 weeks

  • Change in plasma triacylglycerides

    change from baseline to 2, 4, and 24 hours and 2 weeks

  • +22 more secondary outcomes

Study Arms (2)

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.

Dietary Supplement: Onion powder

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

Dietary Supplement: Placebo

Interventions

Onion powderDIETARY_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.

Onion powder
PlaceboDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Diabetes, CVD, hepatitis, HIV/AIDS
  • Cancer or cancer treatment within last 6 months
  • Smoking
  • Simultaneous participation in other research projects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dep. Human Nutrition, LIFE, University of Copenhagen

Frederiksberg C, 1958, Denmark

Location

Department of Nutrition, Exercise and Sports, University of Copenhagen

Frederiksberg C, 1958, Denmark

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 8, 2015

First Posted

May 20, 2015

Study Start

August 1, 2008

Primary Completion

November 1, 2008

Study Completion

April 1, 2009

Last Updated

May 20, 2015

Record last verified: 2015-05

Locations

DK(2)