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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.
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…
Assessments will take place at baseline, after 2 weeks of chiropractic, and after 6 weeks of chiropractic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chiropractic care | Experimental | 6 weeks of chiropractic care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chiropractic | Procedure | Chiropractic spinal adjustments |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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' | 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'. | 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'. | 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'. | 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'. | From enrollment to end of treatment (up to 6 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tyson Perez, DC, PhD | Life University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Life University | Marietta | Georgia | 30067 | United States |
Deidentified IPD necessary to reproduce results
(start date): within 1 year of study completion(end date): indefinitely
IPD, metadata & analytic code necessary to reproduce results will be made publicly accessible via a data repository
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Recruitment began on November 11, 2024, and ended on September 4, 2025. Participants were recruited via word of mouth, flyers, social media posts, trial registries, and newspaper advertisements.
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| ID | Title | Description |
|---|---|---|
| FG000 | Chiropractic Care | 6 weeks of chiropractic care |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Chiropractic Care | 6 weeks of chiropractic care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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' | Posted | Number | Proportion | From lab arrival to completion of on-site screening (up to 15 minutes) |
|
|
From enrollment to completion of baseline assessments (up to 2 hours)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Chiropractic Care | 6 weeks of chiropractic care | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated BP | Vascular disorders | Systematic Assessment | 1 participant was withdrawn by the research staff due to concerns about increased blood pressure following the orthostatic challenge. |
Due to time and funding constraints, recruitment ended prior to achieving our target sample size (i.e., n=20).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tyson Perez, DC, PhD | Life University | 6783314527 | tyson.perez@life.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 25, 2026 | Mar 25, 2026 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 17, 2026 | Mar 17, 2026 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D056128 | Obesity, Abdominal |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D026882 | Manipulation, Chiropractic |
| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| 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'. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline, 2 weeks, 6 weeks |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/meters squared |
|
|
| Primary | 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'. | Posted | Number | Proportion | From start of lifestyle restriction window to lab arrival (up to 24 hours) |
|
|
|
| Primary | 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'. | Posted | Number | Proportion | From enrollment to completion of baseline assessments (up to 2 hours) |
|
|
|
| Primary | 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'. | Note: Of the 18 enrolled participants, 3 withdrew or were withdrawn prior to their initial chiropractic session and therefore were not prescribed a care plan. | Posted | Number | Proportion | From enrollment to end of treatment (up to 6 weeks) |
|
|
|
| Primary | 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'. | Posted | Number | Proportion | From enrollment to end of treatment (up to 6 weeks) |
|
|
|
| Secondary | 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. | Note: Of the 18 enrolled participants, 3 and 4 withdrew or were withdrawn prior to the 2- and 6-week assessments, respectively. | Posted | Least Squares Mean | 95% Confidence Interval | raw scores on a scale | Baseline, 2 weeks, 6 weeks |
|
|
|
| Secondary | 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'. | Note: Of the 18 enrolled participants, 3 and 4 withdrew or were withdrawn prior to the 2- and 6-week assessments, respectively. | Posted | Least Squares Mean | 95% Confidence Interval | T-score | Baseline, 2 weeks, 6 weeks |
|
|
|
| Secondary | 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. | Note: Of the 18 enrolled participants, 3 and 4 withdrew or were withdrawn prior to the 2- and 6-week assessments, respectively. | Posted | Least Squares Mean | 95% Confidence Interval | T-score | Baseline, 2 weeks, 6 weeks |
|
|
|
| Secondary | 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. | Note: Of the 18 enrolled participants, 3 and 4 withdrew or were withdrawn prior to the 2- and 6-week assessments, respectively. | Posted | Least Squares Mean | 95% Confidence Interval | T-score | Baseline, 2 weeks, 6 weeks |
|
|
|
| Secondary | 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. | Note: Of the 18 enrolled participants, 3 and 4 withdrew or were withdrawn prior to the 2- and 6-week assessments, respectively. | Posted | Least Squares Mean | 95% Confidence Interval | Raw score | Baseline, 2 weeks, 6 weeks |
|
|
|
| Secondary | 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. | Note: Of the 18 enrolled participants, 3 and 4 withdrew or were withdrawn prior to the 2- and 6-week assessments, respectively. | Posted | Least Squares Mean | 95% Confidence Interval | msec | Baseline, 2 weeks, 6 weeks |
|
|
|
| Secondary | 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. | Note: Of the 18 enrolled participants, 3 and 4 withdrew or were withdrawn prior to the 2- and 6-week assessments, respectively. | Posted | Least Squares Mean | 95% Confidence Interval | msec | Baseline, 2 weeks, 6 weeks |
|
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|
| Secondary | Changes in sIgA | Changes in salivary-derived secretory immunoglobulin A (sIgA) levels at rest. Salivary-derived sIgA is a measure of mucosal immune function. | Note: Of the 18 enrolled participants, 3 and 4 withdrew or were withdrawn prior to the 2- and 6-week assessments, respectively. | Posted | Least Squares Mean | 95% Confidence Interval | µg/mL | Baseline, 2 weeks, 6 weeks |
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| 18 |
| 0 |
| 18 |
| 1 |
| 18 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ΔPROMIS-29 Social Participation (2 weeks) |
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| ΔPROMIS-29 Social Participation (6 weeks) |
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| ΔPROMIS-29 Anxiety (2 weeks) |
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| ΔPROMIS-29 Anxiety (6 weeks) |
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| ΔPROMIS-29 Depression (2 weeks) |
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| ΔPROMIS-29 Depression (6 weeks) |
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| ΔPROMIS-29 Fatigue (2 weeks) |
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| ΔPROMIS-29 Fatigue (6 weeks) |
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| ΔPROMIS-29 Sleep Disturbance (2 weeks) |
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| ΔPROMIS-29 Sleep Disturbance (6 weeks) |
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| ΔRMSSD during stress (2 weeks) |
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| ΔRMSSD during stress (6 weeks) |
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| ΔRMSSD during recovery (2 weeks) |
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| ΔRMSSD during recovery (6 weeks) |
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| ΔPEP during stress (2 weeks) |
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| ΔPEP during stress (6 weeks) |
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| ΔPEP during recovery (2 weeks) |
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| ΔPEP during recovery (6 weeks) |
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