Physical Activity Modifies Exercise Responsiveness

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
VA Office of Research and Development
Study ID
NCT07792967
Status
Not Yet Recruiting

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Conditions

  • Multimorbidity

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • SLIMM - Sit less, interact, move more — BEHAVIORAL
    To minimize sedentary behavior and increase physical activity the investigators will use our SLIMM intervention. The goal of SLIMM is to replace 1 hour/day of sedentary duration with casual walking time. This goal is \~10% of the average baseline sedentary duration of 10.8 hours/day. While SLIMM is not anchored to a fixed percentage or step count increase, it operationalizes this goal through behavioral coaching and activity monitoring focused on increasing stepping time throughout the day. The SLIMM target duration for decreasing sedentary duration by 1 hour/day is based upon potential impact on energy expenditures and mortality from our previous National Health and Nutrition Examination Survey (NHANES) publication on sedentary behavior in patients with multimorbidity.
  • PB125 — DIETARY_SUPPLEMENT
    The novel naturally derived activator of Nrf2, PB125, contains extracts from three botanical sources including i) Rosmarinus officinalis, standardized to carnosol content of 6%, 68 milligrams (mg) of extract; ii) Withania somnifera (aka Ashwagandha), standardized to withaferin A content of 1%, 23 milligrams (mg) of extract; and iii) Sophora Japonica, standardized to luteolin content of 98%, 9 milligrams (mg) of extract. Each extract can increase the nuclear translocation of Nrf2 and when combined, these extracts act in synergy through multiple control points to amplify and prolong the activation of Nrf2.

Study Details

Exercise is the cornerstone of rehabilitation and an essential part of treatment plans for many chronic conditions; however, our understanding of why certain individuals respond positively to exercise while others do not remains incomplete. Physical inactivity and sedentary behavior have reached epidemic levels, coinciding with alarmingly high levels of multimorbidity in Veterans that, the investigators believe, impair exercise responsiveness and rehabilitation efficacy by disrupting the regulation of redox homeostasis and redox signaling by the transcription factor Nrf2 (nuclear factor erythroid 2-related factor 2). This project will use complementary approaches including 1) the Sit Less, Interact, Move More (SLIMM) intervention, and 2) PB125 to target Nrf2 and break the cycle of sedentary behavior, redox stress, functional impairments, and worsening multimorbidity in older Veterans.

Key Dates

First listed
Aug 28, 2026
Start date
Jan 1, 2027
Status verified
Aug 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2031

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: SLIMM Phase 1
    Sit less, interact, move more (SLIMM). Goal is to replace time spent sedentary with walking.
  • Active Comparator: PB125/Placebo Phase 2
    Participants that are not compliant with SLIMM during Phase 1, will under 12 weeks of PB125 or placebo intervention to improve Nrf2 activation and restore redox homeostasis

Primary Outcome Measure

Vascular function [ Time Frame: pre and post 12 and 24 weeks of intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA Salt Lake City Health Care System, Salt Lake City, UTSalt Lake CityUtah84148-0001
Misti R Seppi, MBA BS AAS
[email protected]
(801) 582-1565
P Jon White, MD
[email protected]
(801) 582-1565
Joel Douglas Trinity, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
VA Salt Lake City Health Care System, Salt Lake City, UT· Salt Lake City, UT

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