Sulforaphane for Age-Related Issues

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Northern Arizona University

Must not be taking: Statins, Blood pressure, Antidepressives, others

Disqualifiers: Diabetes, Liver disease, Renal disease, others

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial is testing if adding a natural compound from vegetables to exercise can make exercise more effective for older adults. The study focuses on people aged 60 and above, who typically don't respond as well to exercise. The treatment aims to boost a protective protein in the body, helping cells stay healthy and improving overall well-being.

Do I need to stop my current medications to join the trial?

Yes, you will need to stop taking certain medications, such as statins, blood pressure medications, and anti-depressives, as they could affect the study's outcome measures.

Is sulforaphane safe for human consumption?

Research indicates that sulforaphane, derived from broccoli and its sprouts, is generally safe for human consumption, as studies have shown no toxicity in liver function tests after ingestion. However, individual responses can vary, and it's important to consider the form and dose of sulforaphane consumed. ^{1 2 3 4 5}

How does sulforaphane differ from other treatments for age-related issues?

Sulforaphane, derived from broccoli, is unique because it targets specific genetic pathways related to aging, such as the TRA-1/GLI and DAF-16/FOXO pathways, which are involved in longevity and healthspan. Unlike other treatments, it also has anti-inflammatory and antioxidant properties, potentially offering a novel approach to managing age-related issues by reducing oxidative stress and inflammation. ^{5 6 7 8 9}

Eligibility Criteria

This trial is for men and women aged 60 or older who can consent to participate, have passed a screening, and have lower than average maximal oxygen consumption. People with recent heart attacks, severe heart conditions, current smokers, those on certain medications like statins or blood pressure drugs, and individuals with chronic illnesses such as diabetes cannot join.

Inclusion Criteria

I am 60 years old or older.

My oxygen consumption is below the recommended level for my gender.

Successful completion of screening

Exclusion Criteria

You have severe obesity with a BMI greater than 33 kg/m2.

I have not taken estrogen in any form in the last 6 months.

I have had a heart attack in the last 6 months, have severe heart valve narrowing, use a heart shock device, or have uncontrolled chest pain.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either sulforaphane supplement or placebo prior to acute exercise to test Nrf2 activation

1 week per trial arm

2 visits (in-person) for each arm

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Sulforaphane (Phytonutrient)

Trial Overview The study is testing if sulforaphane—a compound in cruciferous vegetables—can boost the benefits of exercise in older adults. Participants will either receive sulforaphane capsules or placebo capsules without knowing which one they are taking.

Participant Groups

Group I: SFN supplement Experimental Treatment 2 Interventions

The oral sulforaphane supplement is a myrosinase-active whole broccoli sprout material (EnduraCell Bioactive, Cell-Logic, Queensland, AU) containing 14 mg SFN per capsule. Three capsules will be consumed 90 min prior to the start of the acute exercise trial. The dose of 3 capsules is equivalent to approximately 220 µmol of SFN, which is comparable to that of other studies using broccoli sprout extracts and the recommended single dose.

Group II: Placebo Placebo Group 2 Interventions

Placebo capsules provided by Cell-Logic.

Who Is Running the Clinical Trial?

Northern Arizona University

Lead Sponsor

Trials

36

Recruited

6,300+

Villanova University

Collaborator

Trials

8

Recruited

3,200+

Findings from Research

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]

In a clinical trial with 50 healthy participants, sulforaphane was found to be significantly more bioavailable from a sulforaphane-rich beverage (SFR) compared to a glucoraphanin-rich beverage (GRR), with urinary excretion rates of 70% for SFR versus only 5% for GRR.

The study suggests that combining both SFR and GRR in future formulations could optimize dosing, allowing for both immediate and prolonged effects of sulforaphane, which may enhance its protective actions against cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bioavailability of Sulforaphane from two broccoli sprout beverages: results of a short-term, cross-over clinical trial in Qidong, China. Egner, PA., Chen, JG., Wang, JB., et al.[2022]

Sulforaphane (SFN) and broccoli leaf extract (BLE) significantly reduced lipid accumulation and triglyceride content in fat cells (3T3-L1 adipocytes) and improved metabolic markers in ob/ob mice, indicating their potential as anti-obesity agents.

The treatment with SFN and BLE not only decreased fat storage and improved liver health but also normalized the expression of 32 genes related to lipid metabolism, suggesting a mechanism of action that involves enhancing metabolic pathways in the body.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-obesity effect of sulforaphane in broccoli leaf extract on 3T3-L1 adipocytes and ob/ob mice. Ranaweera, SS., Natraj, P., Rajan, P., et al.[2022]

In a study with male F344 rats, glucoraphanin from broccoli was found to be absorbed intact into the bloodstream, with 5% of the administered dose appearing in urine, indicating its bioavailability.

The study also revealed that glucoraphanin undergoes enterohepatic circulation and is hydrolyzed in the gut, leading to the production of various metabolites, including the beneficial compound sulforaphane.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The metabolic fate of purified glucoraphanin in F344 rats. Bheemreddy, RM., Jeffery, EH.[2022]

Sulforaphane (SF), a beneficial compound from broccoli, is absorbed more effectively from myrosinase-rich broccoli sprouts compared to glucoraphanin-rich broccoli powder, with a 74% recovery in urine from sprouts versus only 19% from the powder.

Combining broccoli sprouts with the powder improved SF absorption, suggesting that this combination could enhance the health benefits of broccoli products without causing any toxicity, as indicated by liver function tests.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sulforaphane absorption and excretion following ingestion of a semi-purified broccoli powder rich in glucoraphanin and broccoli sprouts in healthy men. Cramer, JM., Jeffery, EH.[2021]

Sulphoraphane, a compound found in cruciferous vegetables, shows protective effects against vascular damage in diabetes by acting as an antioxidant and inhibiting the formation of harmful advanced glycation end products (AGEs).

Research indicates that sulphoraphane may reduce inflammation related to AGEs and lower serum levels of AGEs in humans, suggesting it could be a promising new treatment strategy for preventing vascular complications in diabetic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protective role of sulphoraphane against vascular complications in diabetes. Yamagishi, S., Matsui, T.[2022]

A new ultra-fast and accurate method was developed to measure sulforaphane (SFN) and its precursor glucoraphanin (GR) in human urine, demonstrating over 87% recovery and low variability, which is crucial for studying their effects in humans.

After consuming broccoli sprouts, participants showed up to 40% bioavailability of SFN, indicating that dietary intake of broccoli can effectively deliver this beneficial compound to the body.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new ultra-rapid UHPLC/MS/MS method for assessing glucoraphanin and sulforaphane bioavailability in human urine. Dominguez-Perles, R., Medina, S., Moreno, DÁ., et al.[2021]

In a study using C. elegans, sulforaphane from broccoli was found to significantly prolong lifespan and improve mobility and food intake by activating the TRA-1 transcription factor, which is linked to healthy aging.

The beneficial effects of sulforaphane were dependent on the presence of the TRA-1 and DAF-16 genes, indicating that these pathways are crucial for its mechanism of action in promoting longevity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sulforaphane Targets TRA-1/GLI Upstream of DAF-16/FOXO to Promote C. elegans Longevity and Healthspan. Ji, H., Qi, Z., Schrapel, D., et al.[2021]

Aqueous extract from glucoraphanin-rich broccoli sprouts significantly inhibits the formation of advanced glycation end products (AGEs) and reduces inflammatory markers in human umbilical vein endothelial cells (HUVECs), suggesting a protective effect against vascular injury.

The extract also prevents oxidative stress by reducing reactive oxygen species (ROS) generation in HUVECs exposed to AGEs, highlighting its potential as an anti-inflammatory and antioxidant agent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aqueous Extract of Glucoraphanin-Rich Broccoli Sprouts Inhibits Formation of Advanced Glycation End Products and Attenuates Inflammatory Reactions in Endothelial Cells. Sotokawauchi, A., Ishibashi, Y., Matsui, T., et al.[2020]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Bioavailability of Sulforaphane from two broccoli sprout beverages: results of a short-term, cross-over clinical trial in Qidong, China. [2022]

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

Anti-obesity effect of sulforaphane in broccoli leaf extract on 3T3-L1 adipocytes and ob/ob mice. [2022]

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

The metabolic fate of purified glucoraphanin in F344 rats. [2022]

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

Sulforaphane absorption and excretion following ingestion of a semi-purified broccoli powder rich in glucoraphanin and broccoli sprouts in healthy men. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Protective role of sulphoraphane against vascular complications in diabetes. [2022]

7. England pubmed.ncbi.nlm.nih.gov

A new ultra-rapid UHPLC/MS/MS method for assessing glucoraphanin and sulforaphane bioavailability in human urine. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Sulforaphane Targets TRA-1/GLI Upstream of DAF-16/FOXO to Promote C. elegans Longevity and Healthspan. [2021]

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

Aqueous Extract of Glucoraphanin-Rich Broccoli Sprouts Inhibits Formation of Advanced Glycation End Products and Attenuates Inflammatory Reactions in Endothelial Cells. [2020]