- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02322541
Dietary Absorption of Garlic Metabolites Following Garlic Consumption
June 2, 2017 updated by: Janet Novotny, USDA Beltsville Human Nutrition Research Center
The study will consist of a single 5-day dietary treatment period.
Subjects will consume an Allium-free diet for 3 days.
Alliums are vegetables such as garlic, onions, chives, shallots, and leeks.
On day 4, subjects will consume a breakfast consisting of garlic and will then provide blood and urine samples for 10 hours, and on the following morning.
Study Overview
Status
Withdrawn
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maryland
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Beltsville, Maryland, United States, 20705
- USDA Beltsville Human Nutrition Research Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Men and women of age 25 to 75 years at beginning of study
- BMI between 18.5 and 30 kg/m2
- Fasting glucose < 126 mg/dl
- Blood pressure < 160/100 (controlled with certain medications)
- Fasting total blood cholesterol < 280 mg/dl
- Fasting triglycerides < 300 mg/dl
Exclusion Criteria:
- Younger than 25 years old or older than 75 years old
- Use of blood-thinning medications such as Coumadin (warfarin), Dicumarol (dicumarol), or Miradon (anisindione)
- Presence of kidney disease, liver disease, gout, certain cancers, thyroid disease, gastrointestinal, other metabolic diseases or malabsorption syndromes.
- Have been pregnant during the previous 12 months, are currently pregnant or lactating, or plan to become pregnant during the study
- Type 2 diabetes requiring the use of oral antidiabetic agents or insulin
- History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)
- Use of prescription or over-the-counter antiobesity medications or supplements (e.g., phenylpropanolamine, ephedrine, caffeine) during and for at least 6 months prior to the start of the study or a history of a surgical intervention for obesity
- Active cardiovascular disease (such as a heart attack or procedure within the past three months or participation in a cardiac rehabilitation program within the last three months, stroke, or history/treatment for transient ischemic attacks in the past three months, or documented history of pulmonary embolus in the past six months).
- Use of any tobacco products in past 6 months
- Unwillingness to abstain from herbal supplements for two weeks prior to the study and during the study
- Known (self-reported) allergy or adverse reaction to garlic
- Inability to tolerate garlic
- Unable or unwilling to give informed consent or communicate with study staff
- Self-report of alcohol or substance abuse within the past twelve months and/or current acute treatment or rehabilitation program for these problems (Long-term participation in Alcoholics Anonymous is not an exclusion)
- Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Time Course
Measurement of garlic metabolites over 24 hours following garlic intervention.
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Participants will consume an Allium-free controlled diet for 3 days.
On the 4th day, they will consume a test meal containing garlic followed by blood and urine collections for 10 hours.
On the 5th day, participants will have a fasting blood and urine collection.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Allyl methyl sulfide
Time Frame: 24 hour
|
Metabolite will be analyzed in blood and urine.
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24 hour
|
N-acetyl allylcysteine sulfoxide
Time Frame: 24 hour
|
Metabolite will be analyzed in blood and urine.
|
24 hour
|
N-acetyl-S-trans-1-propenylcysteine sulfoxide
Time Frame: 24 hour
|
Metabolite will be analyzed in blood and urine.
|
24 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2016
Primary Completion (Anticipated)
December 1, 2016
Study Completion (Anticipated)
December 1, 2016
Study Registration Dates
First Submitted
December 8, 2014
First Submitted That Met QC Criteria
December 17, 2014
First Posted (Estimate)
December 23, 2014
Study Record Updates
Last Update Posted (Actual)
June 6, 2017
Last Update Submitted That Met QC Criteria
June 2, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- HS48
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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