Dietary Absorption of Garlic Metabolites Following Garlic Consumption

NCT ID: NCT02322541

Last Updated: 2017-06-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2016-12-31

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.

Conditions

Focus is Understanding Absorption of Garlic Metabolites

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Time Course

Measurement of garlic metabolites over 24 hours following garlic intervention.

Group Type: EXPERIMENTAL

Garlic Intervention

Intervention Type: OTHER

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.

Interventions

Garlic Intervention

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

USDA Beltsville Human Nutrition Research Center

FED

Sponsor Role: lead

Responsible Party

Janet Novotny

Research Physiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

USDA Beltsville Human Nutrition Research Center

Beltsville, Maryland, United States

Countries

United States

Other Identifiers

HS48

Identifier Type: -

Identifier Source: org_study_id