Discovery of Biological Signatures for Cruciferous Vegetable Intake (Single Serving)

Study Overview
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Brief Summary
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The purpose of this project is to study the molecular and metabolic profiles in human plasma, urine and microbiome composition following the consumption of broccoli sprouts.

Detailed Description
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The investigators wish to examine metabolic and molecular markers found in blood and in urine after a single dose of sprouts, and evaluate the importance of the gut microbiome on these parameters. Some subjects will receive broccoli sprouts that are grown in deuterium oxide, a commonly used non-toxic, non-radioactive label for vegetables (Tang, Qin et al. 2005), so researchers can identify metabolites in blood and urine that are directly from consumed sprouts. The investigators plan to feed subjects a standardized breakfast and either broccoli sprouts or alfalfa sprouts (control) and look at the presence of metabolites and activity in the blood and urine 3, 6, 24, 48 and 72 hours following intake as well as changes in microbiome composition.

Official Title
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Discovery of Biological Signatures for Cruciferous Vegetable Intake: Integration of the Broccoli- and Host-derived Metabolome and the Microbiome

Conditions
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Diet, Healthy

Intervention / Treatment
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* Other: Broccoli sprouts
* Other: Deuterium oxide-labelled broccoli sprouts
* Other: Alfalfa sprouts
* Other: Deuterium oxide-labelled alfalfa sprouts


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy men and women, 18-60 years of age Willing to stop taking herbal and phytochemical (plant-based extract or phytochemical) supplements for 1 week prior to and during the study Willing to stop cruciferous vegetable and probiotic supplement, food and beverage intake 1 week prior to and during the study Willing to complete a 10-day food diary during the study Must be able to give written informed consent Exclusion Criteria: Body Mass Index (BMI) <18.5 or >30.0 kg/m2 Tobacco use, including e-cigarettes, or smoking of any substance (e.g. cannabis) in the past three months Pregnancy, breastfeeding, or planning to become pregnant before completing the study Engaging in vigorous exercise more than 7 hours per week Have a significant acute or chronic illness such as cardiovascular disease, kidney or liver disease, diabetes, thyroid disorder, or radiation or chemotherapy treatment for cancer within the past five years. Use of medications to control cholesterol (e.g. statins, cholestyramine) or fat absorption (e.g. orlistat) Have had bariatric surgery (e.g. gastric bypass, gastric banding, sleeve gastrectomy, etc.), other gastrointestinal procedure (e.g. cholecystectomy) or disorders (e.g. Crohn's disease, celiac disease, ulcerative colitis) Use of oral antibiotic medication within the 6 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Broccoli sprouts<br>Subjects will consume one serving (about 1 cup) of broccoli sprouts with breakfast (bagel, cream cheese, and orange juice). | Other: Broccoli sprouts<br>* Subjects will consume one serving (about 1 cup) of broccoli sprouts with breakfast (bagel, cream cheese, and orange juice).<br>|
| Active Comparator: Deuterium oxide-labeled broccoli sprouts<br>Subjects will consume one serving (about 1 cup) of deuterium oxide-labeled broccoli sprouts with breakfast (bagel, cream cheese, and orange juice). | Other: Deuterium oxide-labelled broccoli sprouts<br>* Subjects will consume one serving (about 1 cup) of deuterium oxide-labelled broccoli sprouts with breakfast (bagel, cream cheese, and orange juice).<br>|
| Placebo Comparator: Alfalfa sprouts<br>Subjects will consume one serving (about 1 cup) of alfalfa sprouts with breakfast (bagel, cream cheese, and orange juice). | Other: Alfalfa sprouts<br>* Subjects will consume one serving (about 1 cup) of alfalfa sprouts with breakfast (bagel, cream cheese, and orange juice).<br>|
| Placebo Comparator: Deuterium oxide-labeled alfalfa sprouts<br>Subjects will consume one serving (about 1 cup) of deuterium oxide-labeled alfalfa sprouts with breakfast (bagel, cream cheese, and orange juice). | Other: Deuterium oxide-labelled alfalfa sprouts<br>* Subjects will consume one serving (about 1 cup) of deuterium oxide-labelled alfalfa sprouts with breakfast (bagel, cream cheese, and orange juice).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine sulforaphane | Change in levels of sulforaphane metabolites in urine | Baseline, 3, 6, 24, 48 and 72 hours after consuming a single serving of sprouts | 
| Urine sulforaphane metabolites | Change in levels of sulforaphane metabolites in urine | Baseline, 3, 6, 24, 48 and 72 hours after consuming a single serving of sprouts | 
| Plasma sulforaphane | Change in levels of sulforaphane in plasma | Baseline, 3, 6, 24, 48 and 72 hours after consuming a single serving of sprouts | 
| Plasma sulforaphane metabolites | Change in levels of sulforaphane metabolites in plasma | Baseline, 3, 6, 24, 48 and 72 hours after consuming a single serving of sprouts | 
| Stool sample based gut microbiome composition using 16S rRNA gene sequencing | Change in stool sample based gut microbiome composition using 16S rRNA gene sequencing | Baseline, 3, 6, 24, 48 and 72 hours after consuming a single serving of sprouts | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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broccoli sprout, microbiome, cruciferous vegetable