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

Oregon State University (OSU)

Status: Active, not recruiting

Conditions: Diet, Healthy

Treatments: Other: Alfalfa sprouts; Other: Deuterium oxide-labelled alfalfa sprouts; Other: Broccoli sprouts; Other: Deuterium oxide-labelled broccoli sprouts

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04641026

2020-67001-31214 (Other Grant/Funding Number)

LPI-8343

Details and patient eligibility

About

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.

Full 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.

Enrollment: 83 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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83 participants in 4 patient groups, including a placebo group

Broccoli sprouts

Active Comparator group

Description:

Subjects will consume one serving (about 1 cup) of broccoli sprouts with breakfast (bagel, cream cheese, and orange juice).

Treatment:

Other: Broccoli sprouts

Deuterium oxide-labeled broccoli sprouts

Active Comparator group

Description:

Subjects will consume one serving (about 1 cup) of deuterium oxide-labeled broccoli sprouts with breakfast (bagel, cream cheese, and orange juice).

Treatment:

Other: Deuterium oxide-labelled broccoli sprouts

Alfalfa sprouts

Placebo Comparator group

Description:

Subjects will consume one serving (about 1 cup) of alfalfa sprouts with breakfast (bagel, cream cheese, and orange juice).

Treatment:

Other: Alfalfa sprouts

Deuterium oxide-labeled alfalfa sprouts

Placebo Comparator group

Description:

Subjects will consume one serving (about 1 cup) of deuterium oxide-labeled alfalfa sprouts with breakfast (bagel, cream cheese, and orange juice).

Treatment:

Other: Deuterium oxide-labelled alfalfa sprouts