An interventional study of Chiropractic in Abdominal Obesity, sponsored by Life University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by Life University · Not applicable, Interventional, and Treatment
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.
294 studies on the registry are indexed under Obesity, Abdominal; 45 are open to participants now.
This study's enrollment of 18 is below the median of 58 across 234 interventional studies indexed under Obesity, Abdominal.
Browse Obesity, Abdominal studies →Life University is the lead sponsor of 29 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
6 weeks of chiropractic care
Procedure: Chiropractic
Chiropractic spinal adjustments
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'
Time frame: 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'.
Time frame: 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'.
Time frame: 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'.
Time frame: 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'.
Time frame: From enrollment to end of treatment (up to 6 weeks)
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.
Time frame: 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'.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 2 weeks, 6 weeks
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.
| Milestone | Chiropractic Care |
|---|---|
| Started | 18 |
| Completed | 14 |
| Not completed | 4 |
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 | Potential Participants |
|---|---|
| Proportion of Potential Participants Who Are Eligible. | 0.95 |
The number of participants complying with 24hr and 3hr pre-baseline lifestyle restrictions, divided by the total number of participants. This assesses 'Compliance'.
| Proportion | Chiropractic Care |
|---|---|
| Proportion of Participants Complying With Pre-baseline Lifestyle Restrictions | 1.00 |
The number of participants able to complete baseline assessments as directed, divided by the total number of participants. This assesses 'Tolerability'.
| Proportion | Chiropractic Care |
|---|---|
| Proportion of Participants Able to Tolerate the Assessments | 0.94 |
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 | Chiropractic Care |
|---|---|
| Proportion of Participants Adhering to Their Prescribed Care Plan | 0.87 |
Number of participants enrolled who attend the final assessment session, divided by the total number of participants enrolled. This assesses 'Retention'.
| Proportion | Chiropractic Care |
|---|---|
| Proportion of Participants Retained in the Study | 0.78 |
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.
| raw scores on a scale | Chiropractic Care |
|---|---|
| ΔCOMPASS-31 (2 weeks) | -5.95 (-7.63 to -4.28) |
| ΔCOMPASS-31 (6 weeks) | -4.89 (-6.61 to -3.17) |
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'.
| T-score | Chiropractic Care |
|---|---|
| ΔPSS-10 (2 weeks) | -5.42 (-8.69 to -2.15) |
| ΔPSS-10 (6 weeks) | -3.57 (-6.87 to -0.27) |
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.
| T-score | Chiropractic Care |
|---|---|
| ΔPROMIS-Cog 8 (2 weeks) | 3.69 (1.21 to 6.16) |
| ΔPROMIS-Cog 8 (6 weeks) | 2.21 (-0.35 to 4.76) |
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.
| T-score | Chiropractic Care |
|---|---|
| ΔPROMIS-29 Physical Function (2 weeks) | 1.02 (-1.80 to 3.84) |
| ΔPROMIS-29 Physical Function (6 weeks) | 2.31 (-0.60 to 5.21) |
| ΔPROMIS-29 Social Participation (2 weeks) | -1.34 (-4.06 to 1.38) |
| ΔPROMIS-29 Social Participation (6 weeks) | 2.61 (-0.24 to 5.45) |
| ΔPROMIS-29 Anxiety (2 weeks) | -2.05 (-6.21 to 2.11) |
| ΔPROMIS-29 Anxiety (6 weeks) | -2.43 (-6.69 to 1.82) |
| ΔPROMIS-29 Depression (2 weeks) | -1.49 (-3.43 to 0.46) |
| ΔPROMIS-29 Depression (6 weeks) | 0.11 (-1.90 to 2.13) |
| ΔPROMIS-29 Fatigue (2 weeks) | -0.88 (-5.18 to 3.42) |
| ΔPROMIS-29 Fatigue (6 weeks) | -1.92 (-6.29 to 2.45) |
| ΔPROMIS-29 Sleep Disturbance (2 weeks) | -1.21 (-4.14 to 1.72) |
| ΔPROMIS-29 Sleep Disturbance (6 weeks) | -3.90 (-6.89 to -0.90) |
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.
| Raw score | Chiropractic Care |
|---|---|
| ΔPROMIS-29 Pain Intensity (2 weeks) | -0.58 (-1.22 to 0.07) |
| ΔPROMIS-29 Pain Intensity (6 weeks) | 0.28 (-0.37 to 0.93) |
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.
| msec | Chiropractic Care |
|---|---|
| ΔRMSSD at rest (2 weeks) | -4.72 (-13.28 to 4.35) |
| ΔRMSSD at rest (6 weeks) | 1.27 (-8.13 to 10.67) |
| ΔRMSSD during stress (2 weeks) | -3.39 (-7.75 to 0.97) |
| ΔRMSSD during stress (6 weeks) | -4.22 (-8.64 to 0.20) |
| ΔRMSSD during recovery (2 weeks) | -1.60 (-7.02 to 3.81) |
| ΔRMSSD during recovery (6 weeks) | -0.79 (-6.47 to 4.88) |
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.
| msec | Chiropractic Care |
|---|---|
| ΔPEP at rest (2 weeks) | 1.89 (-2.42 to 6.20) |
| ΔPEP at rest (6 weeks) | -0.13 (-4.88 to 4.62) |
| ΔPEP during stress (2 weeks) | -0.29 (-5.41 to 4.82) |
| ΔPEP during stress (6 weeks) | 1.99 (-3.24 to 7.22) |
| ΔPEP during recovery (2 weeks) | -3.28 (-11.80 to 5.24) |
| ΔPEP during recovery (6 weeks) | -0.29 (-8.82 to 8.25) |
Changes in salivary-derived secretory immunoglobulin A (sIgA) levels at rest. Salivary-derived sIgA is a measure of mucosal immune function.
| µg/mL | Chiropractic Care |
|---|---|
| ΔsIgA (2 weeks) | -75.70 (-115.00 to -36.60) |
| ΔsIgA (6 weeks) | -54.10 (-94.00 to -14.30) |
Collected over From enrollment to completion of baseline assessments (up to 2 hours). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Chiropractic Care | 0/18 (0%) | 0/18 (0%) | 1/18 (5.6%) |
| Event | Chiropractic Care |
|---|---|
| Elevated BPVascular disorders | 1/18 |
| Age, Continuous(Years) | Chiropractic Care |
|---|---|
| Mean | 48.77 ± 9.02 |
| Sex: Female, Male(Participants) | Chiropractic Care |
|---|---|
| Female | 12 |
| Male | 6 |
| Race/Ethnicity, Customized(Participants) | Chiropractic Care |
|---|---|
| Race — Black/African American | 7 |
| Race — White/European | 7 |
| Race — Latino/Hispanic | 1 |
| Race — Asian | 1 |
| Race — Mixed | 2 |
| Region of Enrollment(Participants) | Chiropractic Care |
|---|---|
| United States | 18 |
| Body Mass Index (BMI)(kg/meters squared) | Chiropractic Care |
|---|---|
| Mean | 38.62 ± 6.16 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Deidentified IPD necessary to reproduce results
Supporting information: Analytic code
Time frame: (start date): within 1 year of study completion(end date): indefinitely
Access criteria: IPD, metadata \& analytic code necessary to reproduce results will be made publicly accessible via a data repository
Data sharing details ↗ · figshare.com
Ran from Nov 2024 to primary completion in Sep 2025, 9 months.
Results were first posted in May 2026, 8 months after primary completion.
Of 106 non-industry interventional studies with no phase under Obesity, Abdominal, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 29. This study's 9 months is below that.
Counting every sponsor, half of 116 studies reached it within 16 months; a quarter within 7 and three quarters within 33.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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