CompletedNot Applicable

The Effects of Chiropractic in a Population With High Central Adiposity

United States18 participantsStarted 2024-11-11

Plain-language summary

Since 1980, the global prevalence of obesity, commonly defined as a body mass index (BMI) of 30 or higher, has doubled. Importantly, high levels of central adiposity (i.e., abdominal fat) is associated with numerous PNI-related sequelae, including increased levels of psychological distress, cognitive deficits, ANS dysfunction, and immune marker abnormalities. To our knowledge, rigorous investigation of chiropractic's impact on psychoneuroimmunological (PNI)-related outcomes in people with high central adiposity is lacking. Based on limited evidence to date, it is plausible that clinically important PNI-related dysfunctions (e.g., heightened stress levels, executive function impairments, dysautonomia, immune dysregulation) common in this population could be ameliorated via chiropractic care.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 18-65 years of age * Body mass index (BMI) at least 30 * Waist circumference at least 35 inches if female or 40 inches if male Exclusion Criteria: * Had chiropractic care within the past 30 days * Prescribed short-acting benzodiazepines which include midazolam \& triazolam * If taking prescription medications, other than short-acting benzodiazepines, not on a stable dose for a minimum of 6 weeks with plans to change medications or doses during the study * Not able to walk unassisted on a treadmill * Known disorder resulting in syncope/fainting during postural changes (e.g., POTS, orthostatic hypotension) * Pacemaker or known heart condition that influences the electrical or mechanical function of the heart (e.g., severe heart valve disease) * Diagnosed with externalizing (e.g., substance use, antisocial disorder) or thought (e.g., schizophrenia, paranoid personality, bipolar) disorder that is uncontrolled or untreated * Diagnosed with rheumatoid arthritis, osteoporosis, or cervical spine instability * Hearing impairment (cognitive task uses auditory stimuli) * Currently pregnant * Current litigation related to a physical, health-related injury * Whiplash injury in the past 3 months * Oral injury, inflammation, or disease that causes the mouth or gums to bleed easily

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of Potential Participants Who Are Eligible.

Timeframe: From lab arrival to completion of on-site screening (up to 15 minutes)

Proportion of Participants Complying With Pre-baseline Lifestyle Restrictions

Timeframe: From start of lifestyle restriction window to lab arrival (up to 24 hours)

Proportion of Participants Able to Tolerate the Assessments

Timeframe: From enrollment to completion of baseline assessments (up to 2 hours)

Proportion of Participants Adhering to Their Prescribed Care Plan

Timeframe: From enrollment to end of treatment (up to 6 weeks)

Proportion of Participants Retained in the Study

Timeframe: From enrollment to end of treatment (up to 6 weeks)

Trial details

NCT IDNCT06208163

SponsorLife University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-04

Results submitted2026-03-20

View on ClinicalTrials.gov More Abdominal Obesity trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Proportion of Potential Participants Who Are Eligible.

Timeframe: From lab arrival to completion of on-site screening (up to 15 minutes)

Proportion of Participants Complying With Pre-baseline Lifestyle Restrictions

Timeframe: From start of lifestyle restriction window to lab arrival (up to 24 hours)

Proportion of Participants Able to Tolerate the Assessments

Timeframe: From enrollment to completion of baseline assessments (up to 2 hours)

Proportion of Participants Adhering to Their Prescribed Care Plan

Timeframe: From enrollment to end of treatment (up to 6 weeks)

Proportion of Participants Retained in the Study

Timeframe: From enrollment to end of treatment (up to 6 weeks)