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Chemotherapy
Diet Variation for Environmental Exposures
Phase < 1
Waitlist Available
Research Sponsored by Oregon State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up -7 days and 48 hours
Awards & highlights
Study Summary
This trial looked at the levels of a cancer-causing compound, benzo[a]pyrene, in the blood and urine of people who had just been exposed to it, after eating Brussels sprouts, and after taking a supplement containing DIM.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ -7 days and 48 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~-7 days and 48 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Plasma and urine 14C-BaP and 14C-BaP metabolite levels after oral dose
Secondary outcome measures
Area under plasma concentration of 14C-BaP versus time curve AUC
Metabolites of 14C-BaP in plasma
Metabolites of 14C-BaP in urine
+7 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: DIM supplement before 50 ng doseExperimental Treatment1 Intervention
Subjects will consume 300 mg DIM supplement ( 2 capsules of BioResponse DIM® 150) each evening for 7 days prior to taking capsule containing 50 ng (5.4 nCi) [14C]-benzo[a]pyrene (BaP). A 300 mg DIM dose will be co-administrated with the 50 ng BaP dose
Group II: Brussels sprouts before 50 ng doseExperimental Treatment1 Intervention
Subjects will consume 50 g (about 1/2 cup) of lightly steamed Brussels sprouts each evening for 7 days prior to taking capsule containing 50 ng (5.4 nCi) [14C]-benzo[a]pyrene (BaP)
Group III: 50 ng doseExperimental Treatment1 Intervention
Capsule containing 50 ng (5.4 nCi) [14C]-benzo[a]pyrene (BaP)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brussels sprouts before 50 ng dose
2019
Completed Early Phase 1
~10
DIM supplement before 50 ng dose
2019
Completed Early Phase 1
~10
[14C]-benzo[a]pyrene
2018
Completed Early Phase 1
~20
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Who is running the clinical trial?
Oregon State UniversityLead Sponsor
50 Previous Clinical Trials
8,439 Total Patients Enrolled
3 Trials studying Environmental Exposures
453 Patients Enrolled for Environmental Exposures
National Institute of Environmental Health Sciences (NIEHS)NIH
285 Previous Clinical Trials
1,232,776 Total Patients Enrolled
12 Trials studying Environmental Exposures
4,759 Patients Enrolled for Environmental Exposures
Lawrence Livermore National LaboratoryOTHER
5 Previous Clinical Trials
86 Total Patients Enrolled
2 Trials studying Environmental Exposures
13 Patients Enrolled for Environmental Exposures
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are taking medications that can affect how your gut works or how your body absorbs nutrients.You are allergic or intolerant to Brussels sprouts or similar foods.You must avoid certain foods and supplements like broccoli, cauliflower, smoked meat, and cheese for 2 weeks before and during the study. Grilling food on gas is allowed.You have a history of or currently have kidney or liver problems.You have smoked cigarettes or used other tobacco products, or lived with someone who smokes, within the past three months.You regularly take dietary supplements containing indole-3-carbinol or DIM.You have worked in jobs where you may have been exposed to substances that can cause pulmonary arterial hypertension (PAH), such as roofing or asphalt paving.You have had surgery on your gut, such as weight loss surgery or removal of the gallbladder. You also have a history of gut disorders like Crohn's disease, celiac disease, irritable bowel syndrome (IBS), or colitis.
Research Study Groups:
This trial has the following groups:- Group 1: Brussels sprouts before 50 ng dose
- Group 2: DIM supplement before 50 ng dose
- Group 3: 50 ng dose
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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