Clinical trial NCT02322541: Dietary Absorption of Garlic Metabolites Following Garlic Consumption
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Focus is Understanding Absorption of Garlic Metabolites
Lead sponsor: USDA Beltsville Human Nutrition Research Center
Sponsor class: FED
First posted: 2014-12-23
Enrollment: 0
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Allyl methyl sulfide
timeFrame: 24 hour
measure: N-acetyl allylcysteine sulfoxide
timeFrame: 24 hour
measure: N-acetyl-S-trans-1-propenylcysteine sulfoxide
timeFrame: 24 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Beltsville
country: United States
facility: USDA Beltsville Human Nutrition Research Center
state: Maryland
Study officials:
References: