Focus is Understanding Absorption of Garlic Metabolites Clinical Trial
| Verified date | June 2017 |
| Source | USDA Beltsville Human Nutrition Research Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | December 2016 |
| Est. primary completion date | December 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 25 Years to 75 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | USDA Beltsville Human Nutrition Research Center | Beltsville | Maryland |
| Lead Sponsor | Collaborator |
|---|---|
| USDA Beltsville Human Nutrition Research Center |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Allyl methyl sulfide | Metabolite will be analyzed in blood and urine. | 24 hour | |
| Primary | N-acetyl allylcysteine sulfoxide | Metabolite will be analyzed in blood and urine. | 24 hour | |
| Primary | N-acetyl-S-trans-1-propenylcysteine sulfoxide | Metabolite will be analyzed in blood and urine. | 24 hour |