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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up comparing trials separated by one week (supplement vs. placebo)
Awards & highlights
Study Summary
This trial will study whether adding a treatment with phytonutrients found in cruciferous vegetables can improve the exercise response in older individuals.
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.Check my eligibility
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.See study design
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 belowSelect...
I am 60 years old or older.
Select...
My oxygen consumption is below the recommended level for my gender.
Select...
I am capable of understanding and agreeing to the trial's terms on my own.
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Nrf2 activation in response to acute exercise
Secondary outcome measures
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 2013 Phase 2 trial • 20 Patients • NCT0122808435%
Flatulence
35%
Nausea
20%
Bloating
20%
Diarrhea
20%
Dyspepsia
15%
Gatrointestinal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sulpforaphane
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
~550
Placebo capsules
2015
Completed Phase 3
~4330
Find a Location
Who is running the clinical trial?
Northern Arizona UniversityLead Sponsor
32 Previous Clinical Trials
6,692 Total Patients Enrolled
Villanova UniversityOTHER
6 Previous Clinical Trials
3,155 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 60 years old or older.My oxygen consumption is below the recommended level for my gender.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.I do not have chronic illnesses like diabetes, liver or kidney disease, or cancer that could affect the study's outcome.You have a health condition that would make it unsafe for you to undergo maximal exercise testing, such as high blood pressure or problems with your muscles or bones.I am capable of understanding and agreeing to the trial's terms on my own.I am not taking medications like statins, blood pressure drugs, or antidepressants.I don't take more than a daily multivitamin or specific supplements like resveratrol.I have heart rhythm problems seen on an EKG or during a fitness test.You are currently smoking cigarettes.
Research Study Groups:
This trial has the following groups:- Group 1: SFN supplement
- Group 2: Placebo
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies available for participants in this survey?
"According to clinicaltrials.gov, this research initiative is presently seeking volunteers. This trial was first published on September 1st 2022 and has since been revised as of the 26th of that same month."
Answered by AI
How many participants can take part in this clinical research initiative?
"Affirmative. The information on clinicaltrials.gov states that this medical experiment is presently open for enrollment, with an initial posting date of September 1st 2022 and a most recent update on the 26th of September 2022. There are 30 spots available at one healthcare institution."
Answered by AI
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