Treatment Strategy to Enhance Nrf2 Signaling in Older Adults

NCT04848792 | Completed

• 1 other identifier: 1551363
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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 individuals.

Conditions

Aging Problems

Keywords

Redox; Sulforaphane; Nrf2; Exercise

Outcome Measures

Primary Outcomes (1)

• Nrf2 activation in response to acute exercise

  Nrf2/ARE Binding Assay

  Comparing trials separated by one week (supplement vs. placebo)

Secondary Outcomes (3)

• NQO1 gene expression in response to acute exercise

  Comparing trials separated by one week (supplement vs. placebo)

• HO-1 gene expression in response to acute exercise

  Comparing trials separated by one week (supplement vs. placebo)

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

  Comparing trials separated by one week (supplement vs. placebo)

Study Arms (2)

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.

Dietary Supplement: Sulforaphane; Dietary Supplement: Placebo capsules

Placebo

PLACEBO COMPARATOR

Placebo capsules provided by Cell-Logic.

Dietary Supplement: Sulforaphane; Dietary Supplement: Placebo capsules

Interventions

Sulforaphane DIETARY_SUPPLEMENT

Myrosinase-active whole broccoli sprout material

Also known as: EnduraCell Bioactive

Placebo; SFN supplement

Placebo capsules DIETARY_SUPPLEMENT

Placebo capsules

Placebo; SFN supplement

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Northern Arizona University: lead
• Villanova University: collaborator

Study Sites (1)

Northern Arizona University

Flagstaff, Arizona, 86011, United States

Location

Related Publications (1)

• 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. 2025 Oct 16. doi: 10.1007/s11357-025-01939-5. Online ahead of print.

  PMID: 41099966 DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

sulforaphane

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The design of this experiment will be a randomized, double-blind, placebo-controlled, cross-over design, where each subject will serve as their own control. Randomization of order of trials (supplement/placebo) will be performed by a person that is otherwise not part of study personnel, and study personnel and subjects will be blinded to the order. The person doing the randomizing will keep a record of the order using study ID, and researchers will be unblinded upon completion of data collection.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Humans

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: April 19, 2021
• Study Start: February 9, 2023
• Primary Completion: May 27, 2025
• Study Completion: May 27, 2025
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)