Dietary Absorption of Garlic Metabolites Following Garlic Consumption
Not Applicable
Withdrawn
- Conditions
- Focus is Understanding Absorption of Garlic Metabolites
- Interventions
- Other: Garlic Intervention
- Registration Number
- NCT02322541
- Lead Sponsor
- USDA Beltsville Human Nutrition Research Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Time Course Garlic Intervention Measurement of garlic metabolites over 24 hours following garlic intervention.
- Primary Outcome Measures
Name Time Method Allyl methyl sulfide 24 hour Metabolite will be analyzed in blood and urine.
N-acetyl allylcysteine sulfoxide 24 hour Metabolite will be analyzed in blood and urine.
N-acetyl-S-trans-1-propenylcysteine sulfoxide 24 hour Metabolite will be analyzed in blood and urine.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
USDA Beltsville Human Nutrition Research Center
🇺🇸Beltsville, Maryland, United States