Abdominal Obesity
Conditions
Keywords
abdominal obesity, adults, psychoneuroimmunology, chiropractic
Brief 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.
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.
Interventions
PROCEDUREChiropractic
Chiropractic spinal adjustments
Sponsors
Life University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Potential Participants Who Are Eligible. | 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 | 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 | 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 | 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 | 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'. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in COMPASS-31 Raw Scores | Baseline, 2 weeks, 6 weeks | 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. |
| Changes in PSS-10 T-scores | Baseline, 2 weeks, 6 weeks | 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'. |
| Changes in PROMIS-Cog 8 T-scores | Baseline, 2 weeks, 6 weeks | 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. |
| Changes in PROMIS-29 Subscale T-scores | Baseline, 2 weeks, 6 weeks | 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. |
| Changes in PROMIS-29 Subscale Raw Scores | Baseline, 2 weeks, 6 weeks | 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. |
| Changes in RMSSD | Baseline, 2 weeks, 6 weeks | 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. |
| Changes in PEP | Baseline, 2 weeks, 6 weeks | 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. |
| Changes in sIgA | Baseline, 2 weeks, 6 weeks | Changes in salivary-derived secretory immunoglobulin A (sIgA) levels at rest. Salivary-derived sIgA is a measure of mucosal immune function. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTyson Perez, DC, PhD
Life University
Participant flow
Recruitment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 48.77 Years STANDARD_DEVIATION 9.02 |
| Body Mass Index (BMI) | 38.62 kg/meters squared STANDARD_DEVIATION 6.16 |
| Race/Ethnicity, Customized Race Asian | 1 Participants |
| Race/Ethnicity, Customized Race Black/African American | 7 Participants |
| Race/Ethnicity, Customized Race Latino/Hispanic | 1 Participants |
| Race/Ethnicity, Customized Race Mixed | 2 Participants |
| Race/Ethnicity, Customized Race White/European | 7 Participants |
| Region of Enrollment United States | 18 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 18 |
| other Total, other adverse events | 1 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
None listed