Broccoli Sprouts for Ulcerative Colitis

Overseen By Kelli Porzondek

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Must be taking: 5-ASAs, Steroids

Must not be taking: NSAIDs, Antibiotics

Disqualifiers: Diabetes, Cardiovascular disease, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether eating broccoli sprouts can reduce inflammation in people with mild ulcerative colitis, a condition that inflames the colon. The researchers aim to determine the amount of broccoli sprouts needed to increase sulforaphane levels in blood and stool, potentially combating inflammation. Participants will consume either one or three servings of broccoli sprouts to assess which amount is more effective. This trial suits those with a stable ulcerative colitis diagnosis who manage their condition with medication and are comfortable adding broccoli sprouts to their diet. As an unphased trial, it offers participants the chance to contribute to early-stage research that could lead to new dietary recommendations for managing ulcerative colitis.

Will I have to stop taking my current medications?

You can continue taking your current medications for ulcerative colitis as long as the doses are stable and meet the study's requirements. However, you cannot take NSAIDs and should not expect any dose changes during the study.

What prior data suggests that broccoli sprouts are safe for patients with mild ulcerative colitis?

Research shows that broccoli sprouts are generally safe to eat. Studies have found no major or consistent negative side effects when healthy people consume them. Sulforaphane, an important compound in broccoli sprouts, is usually well-tolerated and has been used safely for up to six months. While some people might experience minor side effects, these are uncommon. Overall, broccoli sprouts appear to be a safe choice for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using broccoli sprouts as a treatment for ulcerative colitis because they offer a natural and potentially less invasive alternative to standard therapies like anti-inflammatory drugs or immunosuppressants. Broccoli sprouts are rich in sulforaphane, a compound known for its anti-inflammatory and antioxidant properties, which could help reduce inflammation in the colon uniquely compared to traditional medications. Additionally, consuming broccoli sprouts might result in fewer side effects and can be easily incorporated into the diet, providing a more holistic approach to managing the condition.

What evidence suggests that broccoli sprouts might be an effective treatment for ulcerative colitis?

Research has shown that broccoli sprouts might help reduce inflammation in people with ulcerative colitis. These sprouts contain sulforaphane, a substance that can calm inflammation in the colon. In studies with mice, those that ate broccoli sprouts showed significant improvements in colitis symptoms. This trial will test two different servings of broccoli sprouts to evaluate their effects on ulcerative colitis. Although more research is needed, these early results are promising for people with mild ulcerative colitis. ^{1 2 3 6 7}

Who Is on the Research Team?

Grace Chen

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for adults with mild ulcerative colitis, who are on a stable dose of certain medications like Aminosalicylic acids or Imuran. Participants should have a BMI between 18.5-40 and not be consuming more than 5 ½ cups of fruits and vegetables daily. They must understand the study and consent to it.

Inclusion Criteria

Body Mass Index (BMI) values 18.5-40 kg/m2

Documented endoscopic diagnosis of ulcerative colitis

My ulcerative colitis is mild, confirmed by tests.

Exclusion Criteria

I am currently taking NSAIDs or biologic/immunomodulatory therapies.

Consumption of more than 5 ½ cups of servings/day of fruits and vegetables as assessed by the National Cancer Institute (NCI) Diet History Questionaire III online Food Questionnaire.

I have not taken antibiotics in the last 2 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume broccoli sprouts to assess the impact on sulforaphane levels and inflammatory markers

4 weeks

Weekly self-reports

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Broccoli Sprouts

Trial Overview The study tests if eating either one or three servings of broccoli sprouts can increase sulforaphane levels in the body and decrease inflammation markers in patients with mild ulcerative colitis, as preparation for a larger future trial.

How Is the Trial Designed?

Group I: 3 Servings of broccoli sprouts Experimental Treatment 1 Intervention

339 grams

Group II: 1 Serving of broccoli sprouts Experimental Treatment 1 Intervention

113 grams

Broccoli Sprouts is already approved in Japan, United States for the following indications:

Approved in Japan as Broccoli Sprouts for:

• Ulcerative Colitis

Approved in United States as Broccoli Sprouts for:

• Ulcerative Colitis
• Inflammatory Bowel Disease

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

University of Maine

Collaborator

Trials

4

Recruited

6,700+

Published Research Related to This Trial

Mice fed a diet containing 10% steamed broccoli sprouts showed significant improvements in managing symptoms of ulcerative colitis induced by dextran sodium sulfate, including weight gain and lower levels of inflammatory markers.

The broccoli sprout diet helped maintain a diverse gut microbiota, counteracting the dysbiosis typically caused by colitis, suggesting that dietary interventions could be a promising and accessible strategy for managing Inflammatory Bowel Diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Steamed broccoli sprouts alleviate DSS-induced inflammation and retain gut microbial biogeography in mice. Holman, JM., Colucci, L., Baudewyns, D., et al.[2023]

Mice fed a diet containing 10% steamed broccoli sprouts showed protection against the harmful effects of colitis induced by dextran sodium sulfate, indicating a potential dietary strategy for managing inflammatory bowel disease (IBD).

The study highlights that colitis disrupts the normal bacterial communities in the gut, and suggests that dietary components like broccoli sprouts could help maintain a healthy gut microbiome, offering a promising approach for IBD prevention and recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Steamed broccoli sprouts alleviate DSS-induced inflammation and retain gut microbial biogeography in mice. Holman, JM., Colucci, L., Baudewyns, D., et al.[2023]

Sulforaphane (SFN), derived from cruciferous vegetables, showed potential in reducing symptoms of ulcerative colitis (UC) in mice, as evidenced by improvements in colon length, disease activity index, and inflammation markers after treatment with various doses of SFN.

The protective effects of SFN against UC were linked to the activation of specific biological pathways involving Nrf2 and STAT3, as well as the restoration of gut microbiota, suggesting SFN could be a promising therapeutic agent for UC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Protective Effect of Sulforaphane on Dextran Sulfate Sodium-Induced Colitis Depends on Gut Microbial and Nrf2-Related Mechanism. He, C., Gao, M., Zhang, X., et al.[2022]

A diet including 10% raw broccoli sprouts significantly increased levels of the anti-inflammatory compound sulforaphane in IL-10-KO mice, helping to alleviate symptoms of Crohn's disease such as weight loss and diarrhea.

Younger mice showed a stronger response to the broccoli diet, resulting in greater improvements in gut health and bacterial diversity, suggesting that dietary interventions could be particularly beneficial for younger patients with Crohn's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early life exposure to broccoli sprouts confers stronger protection against enterocolitis development in an immunological mouse model of inflammatory bowel disease. Holcomb, L., Holman, JM., Hurd, M., et al.[2023]

Steamed broccoli sprouts can still provide measurable levels of sulforaphane in the colon and feces, even after the inactivation of the myrosinase enzyme, which is typically responsible for its production.

In a mouse model of inflammatory bowel disease, consumption of steamed broccoli sprouts significantly reduced colitis, and this effect was dependent on a healthy gut microbiota, indicating that gut bacteria play a crucial role in enhancing the anti-inflammatory properties of sulforaphane.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A steamed broccoli sprout diet preparation that reduces colitis via the gut microbiota. Zhang, T., Holman, J., McKinstry, D., et al.[2023]

Sulforaphane (SFN), found in broccoli sprouts, significantly protects against aspirin/NSAIDs-induced small intestinal injury in both in vitro and in vivo studies, suggesting its potential as a preventive treatment.

The protective effects of SFN are linked to the up-regulation of the nrf2-keap1 dependent antioxidant system and a reduction in the invasion of harmful anaerobic bacteria into the intestinal mucosa.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sulforaphane protects small intestinal mucosa from aspirin/NSAID-induced injury by enhancing host defense systems against oxidative stress and by inhibiting mucosal invasion of anaerobic enterobacteria. Yanaka, A., Sato, J., Ohmori, S.[2021]

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]

In a study involving rats with experimentally induced ulcerative colitis, treatment with sulforaphane significantly improved colon morphology and reduced inflammation, suggesting its potential as a therapeutic agent.

Sulforaphane enhanced antioxidant activity and mitochondrial biogenesis while inhibiting DNA polymerization, indicating a multifaceted mechanism of action that could help in treating ulcerative colitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic effects of sulforaphane in ulcerative colitis: effect on antioxidant activity, mitochondrial biogenesis and DNA polymerization. Alattar, A., Alshaman, R., Al-Gayyar, MMH.[2022]

Citations

1. ffhdj.com ffhdj.com/index.php/ffhd/article/download/1440/4044/10228

Dietary intake of sulforaphane-rich broccoli sprouts ... Conclusion: These results ... sulforaphane-rich broccoli sprouts mitigates colonic mucosal inflammation in patients with ulcerative colitis.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05507931

NCT05507931 | Broccoli Sprouts for Mild Ulcerative Colitis Study Overview. The goal of this study is to determine the number of servings of broccoli sprouts sufficient to (1) increase sulforaphane levels in the stool ...

3. withpower.com withpower.com/trial/phase-colitis-8-2022-9e1d0

Broccoli Sprouts for Ulcerative Colitis Mice fed a diet containing 10% steamed broccoli sprouts showed significant improvements in managing symptoms of ulcerative colitis induced by dextran sodium ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0955286322003060

Interplay of broccoli/broccoli sprout bioactives with gut ... Here, we show that 10% steamed broccoli sprouts in the diet protects mice from the negative effects of dextran sodium sulfate-induced colitis, that colitis ...

5. news-medical.net news-medical.net/news/20231114/New-research-reveals-broccoli-sprouts-may-alleviate-Crohns-disease-symptoms-in-youth.aspx

New research reveals broccoli sprouts may alleviate ... Conclusions. Overall, the findings reported that a raw broccoli sprouts diet significantly improved factors such as weight stagnation and blood ...

6. webmd.com webmd.com/vitamins/ai/ingredientmono-1070/sulforaphane

Sulforaphane - Uses, Side Effects, and More Sulforaphane and sulforaphane-rich broccoli extract products have been used safely for up to 6 months. It's usually well-tolerated. Side effects might include ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10313060/

Anticancer properties of sulforaphane: current insights at ... A recent study suggested that sulforaphane is highly beneficial in preventing ulcerative disease by inhibiting the growth of Helicobacter pylori ...