Broccoli Sulforaphane Bioavailability With Mustard

Overseen By Andrew Simonson, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Appalachian State University

Must not be taking: Antibiotics, PPIs, Antacids, Laxatives

Disqualifiers: Diarrhea, GI disorders, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 2 weeks

16 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires you to stop using certain medications like proton pump inhibitors, antacids, and laxatives, as well as supplements like broccoli extracts and multivitamins, for a specific period before and during the study. However, it does not specify about other medications, so it's best to discuss your current medications with the study team.

What data supports the effectiveness of the treatment Broccoli Sulforaphane?

Research suggests that sulforaphane, a compound found in broccoli, may help in cancer prevention by targeting cancer cells and reversing harmful changes in genes. In a study with pancreatic cancer patients, those taking broccoli sulforaphane had a lower death rate in the first 6 months compared to those who did not, although the results were not statistically significant. ^{1 2 3 4 5}

Is broccoli sulforaphane safe for human consumption?

Broccoli sulforaphane has been studied in humans and is generally considered safe, with no significant or consistent adverse effects reported in clinical trials. A study involving healthy volunteers found no concerning safety issues when consuming broccoli sprout extracts containing sulforaphane. ^{3 6 7 8 9}

How does sulforaphane differ from other cancer treatments?

Sulforaphane, found in broccoli and other cruciferous vegetables, is unique because it targets cancer cells by inducing cell cycle arrest and apoptosis (programmed cell death), and it may also reverse harmful changes in gene expression. Unlike many traditional cancer treatments, it is derived from a natural source and has shown potential in preventing cancer development with limited toxicity to normal tissues. ^{2 4 10 11 12}

What is the purpose of this trial?

This trial tests how well healthy adults absorb nutrients from broccoli seed supplements, with or without added mustard seed powder. The study aims to see if mustard seeds help convert a broccoli nutrient into a beneficial compound more effectively. Broccoli and mustard seeds are known for their health benefits, particularly due to compounds like glucoraphanin in broccoli which may reduce cancer and cardiovascular disease risks.

Eligibility Criteria

Inclusion Criteria

Both male and female subjects will be included

Age between 25-65 years inclusive

Non-smoker

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants receive broccoli seed extract supplements with or without mustard seed powder in a randomized crossover design

2 weeks

4 visits (in-person)

Washout

A 7-day washout period between trials to ensure no carryover effects

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• Broccoli Sulforaphane

Participant Groups

Group I: Broccoli seed extract with mustard seed powder Experimental Treatment 1 Intervention

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).

Group II: Broccoli seed extract Active Control 1 Intervention

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).

Who Is Running the Clinical Trial?

Appalachian State University

Lead Sponsor

Trials

46

Recruited

2,600+

Brassica Foundation for Chemoprotection Research

Collaborator

Trials

1

Recruited

20+

Findings from Research

Sulforaphane, derived from cruciferous vegetables like broccoli, shows promising anticancer properties by targeting tumor cells with stem cell-like characteristics, which may help prevent cancer relapse and resistance.

It works through multiple mechanisms, including inhibiting harmful enzymes that activate carcinogens and promoting processes like apoptosis and cell cycle arrest, making it a potential candidate for cancer prevention and treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Sulforaphane in Cancer Chemoprevention: The Role of Epigenetic Regulation and HDAC Inhibition. Tortorella, SM., Royce, SG., Licciardi, PV., et al.[2021]

Broccoli consumption, particularly due to the isothiocyanate sulforaphane derived from its precursor glucoraphanin, has been linked to health benefits, including cancer chemoprotection, supported by over 3000 studies and more than 50 clinical trials.

There is a need for improved integration of animal and human studies to better understand the effective doses and mechanisms of action of sulforaphane, as well as to develop reliable biomarkers for its effects in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Broccoli or Sulforaphane: Is It the Source or Dose That Matters? Yagishita, Y., Fahey, JW., Dinkova-Kostova, AT., et al.[2021]

Sulforaphane (SUL), derived from broccoli, effectively inhibits the proliferation of MCF-7 breast cancer cells by inducing G2/M cell cycle arrest and increasing cyclin B1 protein levels, demonstrating its potential as a cancer treatment.

The mechanism of action for SUL includes disrupting normal tubulin polymerization, which is crucial for cell division, thereby suggesting that it can suppress mammary cancer growth through effects on microtubule dynamics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sulforaphane inhibits human MCF-7 mammary cancer cell mitotic progression and tubulin polymerization. Jackson, SJ., Singletary, KW.[2023]

A phase I clinical study involving healthy volunteers showed that broccoli sprout extracts containing glucoraphanin and sulforaphane were safe and well-tolerated, with no significant adverse effects reported during the treatment period.

The study demonstrated that the isothiocyanate sulforaphane was excreted at a much higher rate (70.6% of the dose) compared to glucosinolates, indicating effective absorption and potential for protective health benefits against diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, tolerance, and metabolism of broccoli sprout glucosinolates and isothiocyanates: a clinical phase I study. Shapiro, TA., Fahey, JW., Dinkova-Kostova, AT., et al.[2022]

Sulforaphane, a compound found in broccoli, effectively induces cell cycle arrest and apoptosis in human lung adenocarcinoma cells, demonstrating its potential as an anti-cancer agent.

In a mouse model, intraperitoneal injection of sulforaphane significantly reduced tumor growth by over 70% compared to control, indicating its efficacy in inhibiting cancer progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sulforaphane induces cell-cycle arrest and apoptosis in cultured human lung adenocarcinoma LTEP-A2 cells and retards growth of LTEP-A2 xenografts in vivo. Liang, H., Lai, B., Yuan, Q.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Broccoli sprout supplementation in patients with advanced pancreatic cancer is difficult despite positive effects-results from the POUDER pilot study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Dietary Sulforaphane in Cancer Chemoprevention: The Role of Epigenetic Regulation and HDAC Inhibition. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Broccoli or Sulforaphane: Is It the Source or Dose That Matters? [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Sulforaphane inhibits human MCF-7 mammary cancer cell mitotic progression and tubulin polymerization. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Sulforaphane Bioavailability from Glucoraphanin-Rich Broccoli: Control by Active Endogenous Myrosinase. [2022]

6. India pubmed.ncbi.nlm.nih.gov

Inhibition of mutagenicity of food-derived heterocyclic amines by sulforaphane--a constituent of broccoli. [2004]

7. United States pubmed.ncbi.nlm.nih.gov

Safety, tolerance, and metabolism of broccoli sprout glucosinolates and isothiocyanates: a clinical phase I study. [2022]

8. Spain pubmed.ncbi.nlm.nih.gov

Clinical and molecular evidence of the consumption of broccoli, glucoraphanin and sulforaphane in humans. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

Absorption and chemopreventive targets of sulforaphane in humans following consumption of broccoli sprouts or a myrosinase-treated broccoli sprout extract. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Sulforaphane induces cell-cycle arrest and apoptosis in cultured human lung adenocarcinoma LTEP-A2 cells and retards growth of LTEP-A2 xenografts in vivo. [2021]

11. Ireland pubmed.ncbi.nlm.nih.gov

Multi-targeted prevention of cancer by sulforaphane. [2021]

12. Germany pubmed.ncbi.nlm.nih.gov

Kinetics of sulforaphane in mice after consumption of sulforaphane-enriched broccoli sprout preparation. [2021]