Abdominal ObesityOBENCT06208163
The Effects of Chiropractic in a Population With High Central Adiposity
A study testing Chiropractic in people with Abdominal Obesity, run by Life University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Abdominal Obesity
- What is being tested?
- Chiropractic
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2024to 4 Sep 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychoneuroimmunology as a Framework for Studying the Effects of Chiropractic Care in a Population With High Central Adiposity: a Pilot Trial
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.
Read the detailed description
Up to twenty (20) obese individuals (18-65 yrs of age) will be recruited. For our trial, obesity will be indexed as a BMI ≥30 and an elevated waist circumference (i.e., >35 inches for women, >40 inches for men).
Subjects will be asked to do the following…
- Restrict certain behaviors prior to their lab visits which include 1) 3 hours prior abstain from caffeine, brushing your teeth, alcohol-based mouthwash, nicotine, food, \& drinking large amounts of liquid very quickly (e.g., chugging a 16 oz bottle of water; sipping water is ok) and 2) 24 hours prior abstain from strenuous exercise, alcohol, \& over the counter drugs (e.g., antihistamines, Tylenol, etc.)
- Have their height, weight, and waist circumference measured.
- Drool into a tube for subsequent testing of immune markers (i.e., salivary IgA)
- Have electrodes placed on/around their chest \& back to measure respiration, ECG, and impedance cardiography (ICG)
- Perform a postural challenge whereby they lay supine (8 min), stand quickly (3 min), and return quickly to the supine position (3 min).
- Have their cognitive function assessed while walking on a treadmill (dual task).
- Answer questions about their mental, physical, and emotional health.
- Receive 6-weeks of chiropractic adjustments from community-based clinicians.
Assessments will take place at baseline, after 2 weeks of chiropractic, and after 6 weeks of chiropractic.
- Conditions
- Abdominal Obesity
- Being tested
- Chiropractic
- Keywords
- abdominal obesity, adults, psychoneuroimmunology, chiropractic
- Medical subject headings
- Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChiropracticProcedure or surgery
Chiropractic spinal adjustments
| Study group | Role | What they receive |
|---|---|---|
| Chiropractic care | Experimental | 6 weeks of chiropractic care Receives: Procedure: Chiropractic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Potential Participants Who Are Eligible.
The number of adults attending the on-site screening who are eligible to participate, divided to the total number of adults attending the on-site screening. This assesses 'Eligibility'
Measured: From lab arrival to completion of on-site screening (up to 15 minutes)
Proportion of Participants Complying With Pre-baseline Lifestyle Restrictions
The number of participants complying with 24hr and 3hr pre-baseline lifestyle restrictions, divided by the total number of participants. This assesses 'Compliance'.
Measured: From start of lifestyle restriction window to lab arrival (up to 24 hours)
Proportion of Participants Able to Tolerate the Assessments
The number of participants able to complete baseline assessments as directed, divided by the total number of participants. This assesses 'Tolerability'.
Measured: From enrollment to completion of baseline assessments (up to 2 hours)
Proportion of Participants Adhering to Their Prescribed Care Plan
The number of participants prescribed a chiropractic care plan that attended ≥80% of their chiropractic sessions, divided by the total number of participants prescribed a chiropractic care plan. This assesses 'Adherence'.
Measured: From enrollment to end of treatment (up to 6 weeks)
Proportion of Participants Retained in the Study
Number of participants enrolled who attend the final assessment session, divided by the total number of participants enrolled. This assesses 'Retention'.
Measured: From enrollment to end of treatment (up to 6 weeks)
Secondary outcomes (8)
Changes in COMPASS-31 Raw Scores
Changes in self-reported autonomic function per the Composite Autonomic Symptom Score (COMPASS-31) survey. The COMPASS-31 is a 31-item questionnaire that evaluates ANS functioning across 6 domains: 1) orthostatic intolerance (4-items), 2) vasomotor (3-items), 3) secretomotor (4-items), 4) gastrointestinal (12-items), 5) bladder (3-items), and 6) pupillomotor (5-items). The domains are weighted, and the sum of the weighted sub-scores yields a total raw score ranging from 0-100. Higher scores indicate greater autonomic dysfunction with total raw scores ≥20 suggested to reflect moderate-to-severe autonomic dysfunction.
Measured: Baseline, 2 weeks, 6 weeks
Changes in PSS-10 T-scores
Changes in perceived stress levels per the 10-item NIH Toolbox Perceived Stress Scale (PSS-10). NIH Toolbox negative emotion measures utilize a 7-day recall period, 5-point Likert scales (e.g., 1=never, 2=almost never, 3=sometimes, 4=fairly often, 5=very often). Total raw scores can range from 10 to 50. Raw scores are converted to standardized uncorrected T-scores (mean=50, SD=10) using conversion tables available in the online scoring instructions (https://www.healthmeasures.net/). Higher scores indicate greater levels of perceived stress with T-scores ≥60 deemed 'potentially problematic'.
Measured: Baseline, 2 weeks, 6 weeks
Changes in PROMIS-Cog 8 T-scores
Changes in self-reported cognitive function per the 8-item PROMIS Cognitive Function (PROMIS-Cog 8) survey. It uses a 7-day recall period and relevant 5-point Likert scales (e.g., 1=never, 2=rarely, 3=sometimes, 4=often, 5=always). Total raw scores can range from 8 to 40. Raw scores are converted to a standardized T-score (mean=50, SD=10) using conversion tables available in the scoring instructions at the PROMIS® website (https://www.healthmeasures.net/). Lower scores indicate greater functional impairment with standard benchmarks for mild (T-score = 40 to 45), moderate (T-score = 30 to 40), or severe (T-score <30) impairment.
Measured: Baseline, 2 weeks, 6 weeks
Changes in PROMIS-29 Subscale T-scores
Changes in self-reported health per the T-scored PROMIS-29 subscales (physical function, social participation, anxiety, depression, fatigue, sleep disturbance). It uses a 7-day recall period and relevant 5-point Likert scales (e.g., 1=never, 2=rarely, 3=sometimes, 4=often, 5=always).Total raw scores can range from 4 to 20. Raw subscale scores are converted to a standardized T-score (mean=50, SD=10) using conversion tables available in the scoring instructions at the PROMIS® website (https://www.healthmeasures.net/). Lower scores on physical function, and social participation subscales indicate greater functional impairment with standard benchmarks for mild (T-score = 40 to 45), moderate (T-score = 30 to 40), or severe (T-score <30) impairment. Higher scores on the anxiety, depression, fatigue, and sleep disturbance subscales indicate greater severity of symptoms with standard benchmarks for mild (T-score = 55 to 60), moderate (T-score = 60 to 70), and severe (T-score >70) symptoms.
Measured: Baseline, 2 weeks, 6 weeks
Changes in PROMIS-29 Subscale Raw Scores
Change in self-reported pain levels per the raw scored PROMIS-29 subscales (pain intensity). This subscale uses a 7-day recall period and is a single item scored on a 1 (no pain) to 10 (worst pain imaginable) scale.
Measured: Baseline, 2 weeks, 6 weeks
Changes in RMSSD
Changes in ECG-derived root mean square of successive differences (RMSSD) during rest, stress, and recovery. RMSSD is a time-domain heart rate variability (HRV) metric used to assess cardiac-related parasympathetic activity.
Measured: Baseline, 2 weeks, 6 weeks
Changes in PEP
Changes in impedance cardiography (ICG)-derived pre-ejection period (PEP) during rest, stress, and recovery. PEP is a time-domain metric used to assess cardiac-related sympathetic activity.
Measured: Baseline, 2 weeks, 6 weeks
Changes in sIgA
Changes in salivary-derived secretory immunoglobulin A (sIgA) levels at rest. Salivary-derived sIgA is a measure of mucosal immune function.
Measured: Baseline, 2 weeks, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start11 Nov 2024
- Primary completion4 Sep 2025
- Study completion4 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal ObesityStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Life University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tyson Perez, DC, PhD, Life University
- Investigators
- Tyson Perez, DC, PhD, Principal investigator, Life University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06208163
- Sponsor's protocol ID
- Perez_OBE_042224
- Acronym
- OBE
- Status last verified
- Apr 2026
- First submitted
- 5 Jan 2024
- Last updated
- 8 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified IPD necessary to reproduce results
Publications
Perez TM, Sliwka M, Smith-Ireland D, Jackson A, Sullivan S. Psychoneuroimmunological changes in adults with obesity receiving chiropractic care: a single-arm pilot trial. Front Psychiatry. 2026 Jul 17;17:1846987. doi: 10.3389/fpsyt.2026.1846987. eCollection 2026.
PubMed 42540508
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychoneuroimmunology as a Framework for Studying the Effects of Chiropractic Care in a Population With High Central Adiposity: a Pilot Trial
- ClinicalTrials.gov ID
- NCT06208163
- Acronym / sponsor ID
- OBE / Perez_OBE_042224
- Conditions
- Abdominal Obesity
- Keywords
- abdominal obesity, adults, psychoneuroimmunology, chiropractic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Life UniversityUniversity, hospital or other
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 4 Sep 2025 (actual)
- Study completion
- 4 Sep 2025 (actual)
- First posted
- 17 Jan 2024 (actual)
- Results
- Posted 8 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Up to twenty (20) obese individuals (18-65 yrs of age) will be recruited. For our trial, obesity will be indexed as a BMI ≥30 and an elevated waist circumference (i.e., >35 inches for women, >40 inches for men).
Subjects will be asked to do the following…
- Restrict certain behaviors prior to their lab visits which include 1) 3 hours prior abstain from caffeine, brushing your teeth, alcohol-based mouthwash, nicotine, food, \& drinking large amounts of liquid very quickly (e.g., chugging a 16 oz bottle of water; sipping water is ok) and 2) 24 hours prior abstain from strenuous exercise, alcohol, \& over the counter drugs (e.g., antihistamines, Tylenol, etc.)
- Have their height, weight, and waist circumference measured.
- Drool into a tube for subsequent testing of immune markers (i.e., salivary IgA)
- Have electrodes placed on/around their chest \& back to measure respiration, ECG, and impedance cardiography (ICG)
- Perform a postural challenge whereby they lay supine (8 min), stand quickly (3 min), and return quickly to the supine position (3 min).
- Have their cognitive function assessed while walking on a treadmill (dual task).
- Answer questions about their mental, physical, and emotional health.
- Receive 6-weeks of chiropractic adjustments from community-based clinicians.
Assessments will take place at baseline, after 2 weeks of chiropractic, and after 6 weeks of chiropractic.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chiropractic care | Experimental | Procedure: Chiropractic6 weeks of chiropractic care |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
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 |
|---|---|---|
| ChiropracticChiropractic spinal adjustments | Procedure or surgery | Chiropractic care |
Primary outcome
Proportion of Potential Participants Who Are Eligible.
Time frame: From lab arrival to completion of on-site screening (up to 15 minutes)
The number of adults attending the on-site screening who are eligible to participate, divided to the total number of adults attending the on-site screening. This assesses 'Eligibility'
Proportion of Participants Complying With Pre-baseline Lifestyle Restrictions
Time frame: From start of lifestyle restriction window to lab arrival (up to 24 hours)
The number of participants complying with 24hr and 3hr pre-baseline lifestyle restrictions, divided by the total number of participants. This assesses 'Compliance'.
Proportion of Participants Able to Tolerate the Assessments
Time frame: From enrollment to completion of baseline assessments (up to 2 hours)
The number of participants able to complete baseline assessments as directed, divided by the total number of participants. This assesses 'Tolerability'.
Proportion of Participants Adhering to Their Prescribed Care Plan
Time frame: From enrollment to end of treatment (up to 6 weeks)
The number of participants prescribed a chiropractic care plan that attended ≥80% of their chiropractic sessions, divided by the total number of participants prescribed a chiropractic care plan. This assesses 'Adherence'.
Proportion of Participants Retained in the Study
Time frame: From enrollment to end of treatment (up to 6 weeks)
Number of participants enrolled who attend the final assessment session, divided by the total number of participants enrolled. This assesses 'Retention'.
8 secondary outcomes
Changes in COMPASS-31 Raw Scores
Time frame: Baseline, 2 weeks, 6 weeks
Changes in PSS-10 T-scores
Time frame: Baseline, 2 weeks, 6 weeks
Changes in PROMIS-Cog 8 T-scores
Time frame: Baseline, 2 weeks, 6 weeks
Changes in PROMIS-29 Subscale T-scores
Time frame: Baseline, 2 weeks, 6 weeks
Changes in PROMIS-29 Subscale Raw Scores
Time frame: Baseline, 2 weeks, 6 weeks
Changes in RMSSD
Time frame: Baseline, 2 weeks, 6 weeks
Changes in PEP
Time frame: Baseline, 2 weeks, 6 weeks
Changes in sIgA
Time frame: Baseline, 2 weeks, 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42540508Perez TM, Sliwka M, Smith-Ireland D, Jackson A, Sullivan S. Psychoneuroimmunological changes in adults with obesity receiving chiropractic care: a single-arm pilot trial. Front Psychiatry. 2026 Jul 17;17:1846987. doi: 10.3389/fpsyt.2026.1846987. eCollection 2026.
- Individual participant dataSharing planned: Yes. Deidentified IPD necessary to reproduce results
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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.
Tyson Perez, DC, PhD principal investigator
Life University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chiropractic in people with Abdominal Obesity, run by Life 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 3 inclusion and 13 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 8 May 2026. 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. 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?
Yes. Results are posted in the registry (first posted 8 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Potential Participants Who Are Eligible. (time frame: From lab arrival to completion of on-site screening (up to 15 minutes)). The study lists 5 primary outcomes in all. 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 NCT06208163, 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 8 May 2026.