What is the mechanism of action of this treatment?

Phytonutrients found in cruciferous vegetables, such as sulforaphane, exert their beneficial effects primarily through their antioxidant and anti-inflammatory properties. These compounds activate cellular pathways that enhance the body's natural defense mechanisms against oxidative stress and inflammation, which are significant contributors to the aging process and age-related diseases. By reducing oxidative damage and inflammatory responses, these phytonutrients can help maintain cellular health, improve vascular function, and potentially lower the risk of chronic diseases such as cardiovascular disease and neurodegenerative disorders. This is particularly important for aging patients as it can improve their overall health and quality of life.

What side effects are associated with this type of intervention?

Common treatments for age-related issues that involve phytonutrients from cruciferous vegetables, such as sulforaphane and other antioxidants, generally have a good safety profile. However, some individuals may experience mild gastrointestinal discomfort, including gas, bloating, or diarrhea. Long-term use of high doses of these supplements could potentially interfere with thyroid function due to the goitrogenic properties of some cruciferous vegetables. It is important to consult with a healthcare provider before starting any new supplement regimen.

What prior FDA approvals exist?

The FDA has approved various treatments for age-related issues, focusing on antioxidant and anti-inflammatory properties similar to those found in phytonutrients from cruciferous vegetables. Notable approvals include drugs like antioxidants (e.g., Vitamin E) and anti-inflammatory agents (e.g., NSAIDs) that help manage oxidative stress and inflammation, common in aging. Additionally, dietary supplements such as omega-3 fatty acids and lycopene have been studied for their potential benefits in reducing symptoms of age-related conditions like heart failure.

What other types of research exist?

Promising alternatives to phytonutrients from cruciferous vegetables for age-related issues include curcuminoids combined with piperine, which have shown significant antioxidant and anti-inflammatory effects. Additionally, omega-3 polyunsaturated fatty acids and vitamin D have been noted for their potential benefits in reducing inflammation and supporting overall health in aging populations.

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Sulforaphane for Age-Related Issues

N/A

Recruiting

Research Sponsored by Northern Arizona University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Men and women, 60 years and older

Maximal oxygen consumption below the 60th percentile based on gender: Women: ≤ 21.2 mL/kg/min Men: ≤ 30.5 mL/kg/min

Must not have

History of a myocardial infarction within the last 6 months, clinically significant aortic stenosis, use of cardiac defibrillator, or uncontrolled angina

Any chronic illness that could affect outcome measures, including diabetes, liver or renal disease, or cancer (other than skin cancer)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up comparing trials separated by one week (supplement vs. placebo)

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Sulforaphane may cause gas or bowel irritation due to its effects on digestion. Since it's derived from vegetables like broccoli, people sensitive to these might experience similar discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 60 years old or older.

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

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I am capable of understanding and agreeing to the trial's terms on my own.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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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.

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I do not have chronic illnesses like diabetes, liver or kidney disease, or cancer that could affect the study's outcome.

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I am not taking medications like statins, blood pressure drugs, or antidepressants.

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I don't take more than a daily multivitamin or specific supplements like resveratrol.

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I have heart rhythm problems seen on an EKG or during a fitness test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ comparing trials separated by one week (supplement vs. placebo)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~comparing trials separated by one week (supplement vs. placebo)

This trial's timeline: 3 weeks for screening, Varies for treatment, and comparing trials separated by one week (supplement vs. placebo) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Nrf2 activation in response to acute exercise

Secondary study objectives

Glutathione reductase (GR) gene expression in response to acute exercise

HO-1 gene expression in response to acute exercise

NQO1 gene expression in response to acute exercise

Side effects data

From 2023 Phase 2 trial • 43 Patients • NCT03232138

81%

Others

62%

Flatulence

48%

Diarrhea

43%

Insomnia

38%

Stomachache

33%

Constipation

33%

Mood Alteration

29%

Dry Mouth

29%

Nausea

29%

Dizziness

24%

Tremor

19%

Belching

14%

Distension

14%

Headache

10%

Vomiting

Bad taste

100%

80%

60%

40%

20%

Study treatment Arm

Sulforaphane (Study Drug)

Placebo

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SFN supplementExperimental Treatment2 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: PlaceboPlacebo Group2 Interventions

Placebo capsules provided by Cell-Logic.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sulforaphane

2016

Completed Phase 3

~530

Placebo capsules

2015

Completed Phase 3

~4330

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Phytonutrients found in cruciferous vegetables, such as sulforaphane, exert their beneficial effects primarily through their antioxidant and anti-inflammatory properties. These compounds activate cellular pathways that enhance the body's natural defense mechanisms against oxidative stress and inflammation, which are significant contributors to the aging process and age-related diseases. By reducing oxidative damage and inflammatory responses, these phytonutrients can help maintain cellular health, improve vascular function, and potentially lower the risk of chronic diseases such as cardiovascular disease and neurodegenerative disorders. This is particularly important for aging patients as it can improve their overall health and quality of life.

Healthy lifestyle-based approaches for successful vascular aging.Beta carotene: from biochemistry to clinical trials.