Broccoli Sulforaphane Bioavailability With Mustard

NCT04946526 | Completed

• 1 other identifier: 21-0216
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

We know that broccoli is a vegetable that is associated with a number of health benefits and is a good choice in a healthy diet. Researchers at major universities, including Johns Hopkins University, have identified nutrients in broccoli that have specific health benefits such as improving antioxidant protection. One of these nutrients is called glucoraphanin (GR). However, in order for GR to deliver health benefits in the human body, it first has to be converted to its active form, sulforaphane (SF). This conversion can happen one of two ways. GR can be converted to SF by our gut bacteria (the microbiota) or it can be converted to SF by an enzyme called myrosinase that is naturally occurring in certain plants, including mustard (the same mustard that is used to make table mustard spread and mayonnaise). The purpose of the present study is to test in healthy human volunteers the oral bioavailability (absorption) of GR in broccoli seed extract (BSE) with or without the presence of active plant myrosinase in mustard seed powder (MSP) delivered in a nutritional supplement.

Conditions

Sulforaphane Bioavailability

Keywords

broccoli; mustard; sulforaphane; glucoraphanin; bioavailability

Outcome Measures

Primary Outcomes (1)

• Urine concentration of sulforaphane

  Broccoli glucosinolate metabolite

  Change from pre-ingestion to 8- and 24-hours post-ingestion

Secondary Outcomes (1)

• Urine concentration of dithiocarbamate

  Change from pre-ingestion to 8- and 24-hours post-ingestion

Study Arms (2)

Broccoli seed extract

ACTIVE COMPARATOR

A single dose dietary supplement made up of 385 mg broccoli seed extract delivering 50 mg GR (115 umol GR) and 100 mg vitamin C (as ascorbic acid).

Dietary Supplement: Broccoli seed extract

Broccoli seed extract with mustard seed powder

EXPERIMENTAL

A single dose dietary supplement made up of a mixture of 385 mg broccoli seed extract delivering 50 mg GR (115 umol GR), 145 mg mustard seed powder containing enough active myrosinase (enzyme) to fully hydrolyze the GR in the capsule to SF post-ingestion (\~30 units myrosinase activity) and 100 mg vitamin C (as ascorbic acid).

Dietary Supplement: Broccoli seed extract with mustard seed powder

Interventions

Broccoli seed extract DIETARY_SUPPLEMENT

2 capsules, one dose

Broccoli seed extract

Broccoli seed extract with mustard seed powder DIETARY_SUPPLEMENT

2 capsules, one dose

Broccoli seed extract with mustard seed powder

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both male and female subjects will be included
• Age between 25-65 years inclusive
• Non-smoker
• Healthy subjects who, in the opinion of the investigator, are free of any medical conditions that might affect study measures
• Body Mass Index (BMI) of 20 - 29.9 kg/m2
• Willingness to adhere to dietary restrictions: refrain from consuming cruciferous vegetables and condiments that might contain glucosinolates or isothiocyanates (e.g., prepared mustard aka deli mustard, mustard greens, horseradish, wasabi, mayonnaise) for 3 days before and for the duration of the study
• Subjects willing to consume the light breakfast consisting of a muffin and 12 oz coffee
• Subjects willing to collect all urine for 24 hours on two separate occasions
• Subjects that have given voluntary, written, informed consent to participate in the study

You may not qualify if:

• Diarrhea or oral antibiotic intake within the last 4 weeks
• Use of proton pump inhibitors (PPIs), antacids or other medications that influence stomach acidity
• Use of laxative medications or other products that promote colon cleansing in the last 4 weeks
• History of malabsorption or GI tract disorders or GI surgeries (i.e. lapband, gastric bypass, etc.)
• Supplementation with broccoli sprout, seed or powder extracts, or other over the counter supplements including the other bioactive ingredients in the test supplement, antioxidants and multi-vitamin mineral supplements, including vitamin C (ascorbic acid), for the previous 2 weeks
• Subject has a known allergy or intolerance to any of the ingredients contained in the test supplements (e.g. broccoli, broccoli seeds, mustard seeds, vitamin C (ascorbic acid))
• Subject is currently pregnant, planning to become pregnant, or is breastfeeding
• Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject

Sponsors & Collaborators

• Appalachian State University: lead
• Brassica Foundation for Chemoprotection Research: collaborator

Study Sites (1)

Appalachian State University Human Performance Lab, North Carolina Research Campus

Kannapolis, North Carolina, 28081, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Supplements (broccoli seed extract, BSE, and vitamin C (VC) with or without mustard seed powder, MSP) will be in identical capsules, with the double blind code held by the sponsor until after the study is over.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized crossover with a 7 day washout period between trials.

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: July 1, 2021
• Study Start: June 1, 2022
• Primary Completion: August 30, 2022
• Study Completion: September 30, 2022
• Last Updated: January 25, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)