Dietary Absorption of Garlic Metabolites Following Garlic Consumption

Beltsville Human Nutrition Research Center (BHNRC)

Status

Withdrawn

Conditions

Focus is Understanding Absorption of Garlic Metabolites

Treatments

Other: Garlic Intervention

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT02322541

HS48

Details and patient eligibility

About

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.

Sex

All

Ages

25 to 75 years old

Volunteers

Accepts Healthy Volunteers

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