Aging ProblemsNCT04848792
Treatment Strategy to Enhance Nrf2 Signaling in Older Adults
A study testing Sulforaphane in people with Aging Problems, run by Northern Arizona University at 1 site in United States.
Trial summary
Exercise is the cornerstone of disease prevention and often an important component of treatment. However, the efficacy of an exercise stimulus is reduced with aging. This study will investigate whether adding a treatment with phytonutrients found in cruciferous vegetables can improve the exercise response in older… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging Problems
- What is being tested?
- Sulforaphane
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2023to 27 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women, 60 years and older
- Competent to independently give informed consent
- Successful completion of screening
- Maximal oxygen consumption below the 60th percentile based on gender:
- Women: ≤ 21.2 mL/kg/min
- Men: ≤ 30.5 mL/kg/min
Who cannot join
- Estrogen supplementation (in any form) within the previous 6 months
- Any medication that could affect outcome measures such as statins, blood pressure medications, or anti-depressives
- Use of anti-oxidant supplements, in excess of standard multi-vitamins (1 tablet/day) and/or any supplements known to target Nrf2 including resveratrol, Protandim, and sulforaphane
- Current smoker
- Body Mass Index (BMI) greater than 33 kg/m2 (Class I Obesity)
- Any chronic illness that could affect outcome measures, including diabetes, liver or renal disease, or cancer (other than skin cancer)
Show all 9Show fewer
- History of a myocardial infarction within the last 6 months, clinically significant aortic stenosis, use of cardiac defibrillator, or uncontrolled angina
- Clinically significant arrhythmia on a resting EKG or significant EKG changes during the baseline VO2 max test
- Any other condition that would contraindicate maximal exercise testing, including elevated blood pressure at rest (systolic BP >150 or diastolic BP >90 mm Hg on at least 2 measurements, at least 10 minutes apart) or musculoskeletal problems
Trial locations and contacts
1 site in 1 country.
United States1 site
Northern Arizona University
Flagstaff, Arizona, 86011
About this study
Official title: Treatment Strategy to Enhance Nrf2 Signaling in Older Adults: Combining Acute Exercise With the Phytochemical Sulforaphane
Exercise is the cornerstone of disease prevention and often an important component of treatment. However, the efficacy of an exercise stimulus is reduced with aging. This study will investigate whether adding a treatment with phytonutrients found in cruciferous vegetables can improve the exercise response in older individuals.
Read the detailed description
Redox balance plays a key role in the age-associated increased risk for diseases. One reason for the lower resistance to oxidative stress with age is a gradual shift in the redox state toward a more oxidized cellular environment resulting in disruption of cell signaling. Nuclear erythroid factor 2-related factor 2 (Nrf2) is the master regulator of antioxidant defenses. Nrf2 drives expression of a host of genes involved in cytoprotection and antioxidant defenses. The Traustadottir lab was the first to demonstrate Nrf2 activation in response to acute exercise in humans, and in agreement with animal data, found an age-related impairment in exercise-induced Nrf2 signaling. This underscores an important problem related to aging, namely that older individuals are less sensitive to an exercise stimulus compared to younger cohorts. The focus of the proposed study is to try to solve this problem by amplifying the signal and mitigating the "exercise desensitization" exhibited by older individuals to restore redox balance. This study will test the hypothesis that combining acute exercise with sulforaphane will improve Nrf2 activation and downstream signaling in older adults compared to either alone. Sulforaphane (SFN) is a phytonutrient found in high concentrations in cruciferous vegetables and a potent Nrf2 activator. The hypothesis will be tested using two different approaches; the first experiment will use an in vivo-ex vivo approach, where peripheral blood mononuclear cells (PBMCs) collected from older men and women (≥60y, n=30) pre- and post-acute exercise (in vivo) will be cultured and stimulated with SFN (ex vivo). This allows for a greater experimental control of the SFN stimulus. The second experiment will test the clinical translation applying the sulforaphane stimulus in vivo through an oral supplementation of sulforaphane in the form of whole broccoli sprout material, prior to acute exercise, in the same individuals. This second experiment will be a randomized placebo-controlled cross-over design. For all trials Nrf2 signaling will be measured by Nrf2 activation through an ARE binding assay, nuclear to whole cell ratio of Nrf2 protein, and Nrf2-dependent gene expression (HO-1, GCLC, NQO1, GR). Potential sex differences will be investigated. The insights gained from this study are whether combining simple interventions in the category of healthy lifestyle and preventive medicine can improve the adaptive response to exercise in older individuals. This could have an enormous impact by improving the health and well-being of older Americans.
- Conditions
- Aging Problems
- Being tested
- Sulforaphane, Placebo capsules
- Keywords
- Redox, Sulforaphane, Nrf2, Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SulforaphaneDietary supplement
Also called EnduraCell Bioactive
Myrosinase-active whole broccoli sprout material
Placebo capsulesDietary supplement
Placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| SFN supplement | Experimental | 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. Receives: Dietary Supplement: Sulforaphane; Dietary Supplement: Placebo capsules |
| Placebo | Placebo comparator | Placebo capsules provided by Cell-Logic. Receives: Dietary Supplement: Sulforaphane; Dietary Supplement: Placebo capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nrf2 activation in response to acute exercise
Nrf2/ARE Binding Assay
Measured: Comparing trials separated by one week (supplement vs. placebo)
Secondary outcomes (3)
NQO1 gene expression in response to acute exercise
NQO1 mRNA measured with RT-qPCR
Measured: Comparing trials separated by one week (supplement vs. placebo)
HO-1 gene expression in response to acute exercise
HO-1 mRNA measured with RT-qPCR
Measured: Comparing trials separated by one week (supplement vs. placebo)
Glutathione reductase (GR) gene expression in response to acute exercise
GR mRNA measured with RT-qPCR
Measured: Comparing trials separated by one week (supplement vs. placebo)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start9 Feb 2023
- Primary completion27 May 2025
- Study completion27 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aging ProblemsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Humans
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Arizona University
- Sponsor type
- University, hospital or other
- Collaborators
- Villanova University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04848792
- Sponsor's protocol ID
- 1551363
- Status last verified
- Aug 2025
- First submitted
- 16 Mar 2021
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rodriguez DJ, Ostrom EL, Chassman C, Robertson J, Pan V, Buscaglia R, Eggler AL, Traustadottir T. Sulforaphane improves exercise-induced NRF2 signaling in older adults: an in vivo-ex vivo approach. Geroscience. 2026 Apr;48(2):2085-2100. doi: 10.1007/s11357-025-01939-5. Epub 2025 Oct 16.
PubMed 41099966
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Strategy to Enhance Nrf2 Signaling in Older Adults: Combining Acute Exercise With the Phytochemical Sulforaphane
- ClinicalTrials.gov ID
- NCT04848792
- Acronym / sponsor ID
- 1551363
- Conditions
- Aging Problems
- Keywords
- Redox, Sulforaphane, Nrf2, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Northern Arizona UniversityUniversity, hospital or other
- Collaborators
- Villanova University
- Study start
- 9 Feb 2023 (actual)
- Primary completion
- 27 May 2025 (actual)
- Study completion
- 27 May 2025 (actual)
- First posted
- 19 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Exercise is the cornerstone of disease prevention and often an important component of treatment. However, the efficacy of an exercise stimulus is reduced with aging. This study will investigate whether adding a treatment with phytonutrients found in cruciferous vegetables can improve the exercise response in older individuals.
Detailed description
Redox balance plays a key role in the age-associated increased risk for diseases. One reason for the lower resistance to oxidative stress with age is a gradual shift in the redox state toward a more oxidized cellular environment resulting in disruption of cell signaling. Nuclear erythroid factor 2-related factor 2 (Nrf2) is the master regulator of antioxidant defenses. Nrf2 drives expression of a host of genes involved in cytoprotection and antioxidant defenses. The Traustadottir lab was the first to demonstrate Nrf2 activation in response to acute exercise in humans, and in agreement with animal data, found an age-related impairment in exercise-induced Nrf2 signaling. This underscores an important problem related to aging, namely that older individuals are less sensitive to an exercise stimulus compared to younger cohorts. The focus of the proposed study is to try to solve this problem by amplifying the signal and mitigating the "exercise desensitization" exhibited by older individuals to restore redox balance. This study will test the hypothesis that combining acute exercise with sulforaphane will improve Nrf2 activation and downstream signaling in older adults compared to either alone. Sulforaphane (SFN) is a phytonutrient found in high concentrations in cruciferous vegetables and a potent Nrf2 activator. The hypothesis will be tested using two different approaches; the first experiment will use an in vivo-ex vivo approach, where peripheral blood mononuclear cells (PBMCs) collected from older men and women (≥60y, n=30) pre- and post-acute exercise (in vivo) will be cultured and stimulated with SFN (ex vivo). This allows for a greater experimental control of the SFN stimulus. The second experiment will test the clinical translation applying the sulforaphane stimulus in vivo through an oral supplementation of sulforaphane in the form of whole broccoli sprout material, prior to acute exercise, in the same individuals. This second experiment will be a randomized placebo-controlled cross-over design. For all trials Nrf2 signaling will be measured by Nrf2 activation through an ARE binding assay, nuclear to whole cell ratio of Nrf2 protein, and Nrf2-dependent gene expression (HO-1, GCLC, NQO1, GR). Potential sex differences will be investigated. The insights gained from this study are whether combining simple interventions in the category of healthy lifestyle and preventive medicine can improve the adaptive response to exercise in older individuals. This could have an enormous impact by improving the health and well-being of older Americans.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Humans
| Arm | Type | Receives |
|---|---|---|
| SFN supplement | Experimental | Dietary Supplement: Sulforaphane, Dietary Supplement: Placebo capsulesThe 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. |
| Placebo | Placebo comparator | Dietary Supplement: Sulforaphane, Dietary Supplement: Placebo capsulesPlacebo capsules provided by Cell-Logic. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women, 60 years and older
- Competent to independently give informed consent
- Successful completion of screening
- Maximal oxygen consumption below the 60th percentile based on gender:
- Women: ≤ 21.2 mL/kg/min
Key exclusion criteria (9 listed)
- Estrogen supplementation (in any form) within the previous 6 months
- Any medication that could affect outcome measures such as statins, blood pressure medications, or anti-depressives
- Use of anti-oxidant supplements, in excess of standard multi-vitamins (1 tablet/day) and/or any supplements known to target Nrf2 including resveratrol, Protandim, and sulforaphane
- Current smoker
- Body Mass Index (BMI) greater than 33 kg/m2 (Class I Obesity)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SulforaphaneAlso: EnduraCell BioactiveMyrosinase-active whole broccoli sprout material | Dietary supplement | Placebo, SFN supplement |
| Placebo capsulesPlacebo capsules | Dietary supplement | Placebo, SFN supplement |
Primary outcome
Nrf2 activation in response to acute exercise
Time frame: Comparing trials separated by one week (supplement vs. placebo)
Nrf2/ARE Binding Assay
3 secondary outcomes
NQO1 gene expression in response to acute exercise
Time frame: Comparing trials separated by one week (supplement vs. placebo)
HO-1 gene expression in response to acute exercise
Time frame: Comparing trials separated by one week (supplement vs. placebo)
Glutathione reductase (GR) gene expression in response to acute exercise
Time frame: Comparing trials separated by one week (supplement vs. placebo)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Derived from this study: PubMed 41099966Rodriguez DJ, Ostrom EL, Chassman C, Robertson J, Pan V, Buscaglia R, Eggler AL, Traustadottir T. Sulforaphane improves exercise-induced NRF2 signaling in older adults: an in vivo-ex vivo approach. Geroscience. 2026 Apr;48(2):2085-2100. doi: 10.1007/s11357-025-01939-5. Epub 2025 Oct 16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sulforaphane in people with Aging Problems, run by Northern Arizona University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nrf2 activation in response to acute exercise (time frame: Comparing trials separated by one week (supplement vs. placebo)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04848792, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.