Clinical trial NCT04641026: Discovery of Biological Signatures for Cruciferous Vegetable Intake (Single Serving)
Official title: Discovery of Biological Signatures for Cruciferous Vegetable Intake: Integration of the Broccoli- and Host-derived Metabolome and the Microbiome
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diet, Healthy
Keywords: broccoli sprout
microbiome
cruciferous vegetable
Lead sponsor: Oregon State University
Sponsor class: OTHER
Collaborators: name: United States Department of Agriculture (USDA)
First posted: 2020-11-23
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Urine sulforaphane
timeFrame: Baseline, 3, 6, 24, 48 and 72 hours after consuming a single serving of sprouts
measure: Urine sulforaphane metabolites
timeFrame: Baseline, 3, 6, 24, 48 and 72 hours after consuming a single serving of sprouts
measure: Plasma sulforaphane
timeFrame: Baseline, 3, 6, 24, 48 and 72 hours after consuming a single serving of sprouts
measure: Plasma sulforaphane metabolites
timeFrame: Baseline, 3, 6, 24, 48 and 72 hours after consuming a single serving of sprouts
measure: Stool sample based gut microbiome composition using 16S rRNA gene sequencing
timeFrame: Baseline, 3, 6, 24, 48 and 72 hours after consuming a single serving of sprouts
Secondary outcomes:
Other outcomes:
Locations:
city: Corvallis
country: United States
facility: Oregon State University
state: Oregon
Study officials:
affiliation: Oregon State University
name: Emily Ho, PhD
role: PRINCIPAL_INVESTIGATOR
References: