The Effects of Chiropractic in a Population with High Central Adiposity
- Conditions
- Abdominal Obesity
- Interventions
- Procedure: Chiropractic
- Registration Number
- NCT06208163
- Lead Sponsor
- Life University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Chiropractic care Chiropractic 6 weeks of chiropractic care
- Primary Outcome Measures
Name Time Method Retention 6 weeks proportion of participants completing the trial
Latency 6 weeks Average time between first lab assessment \& first chiropractic session
Compliance 6 weeks proportion of participants complying with pre-assessment lifestyle restrictions
Recruitment up to 6 months Average number of participants recruited/enrolled per month
Adherence 6 weeks proportion of participants attending ≥80% of their chiropractic sessions
Efficiency 6 weeks Average battery duration
Tolerability 6 weeks % of participants able to complete a given assessment
Acceptability 6 weeks proportion of participant-rated \& clinician-rated acceptability scores ≥3 in each domain
Data quality 6 weeks % of acquisitions from a given assessment that are suitable for analysis
- Secondary Outcome Measures
Name Time Method Cognitive Flexibility 6 weeks Modulation of executive function (i.e., cognitive flexibility) as indicated by changes in auditory switch task reaction time and decision error rate during gait
Gait 6 weeks Modulation of gait as indicated by changes in the percentage of time spent in stance phase, load response, swing phase, single support, pre-swing, and initial swing.
Heart rate variability 6 weeks Modulation of electrocardiography (ECG)-derived heart rate variability (HRV) during rest, stress, and recovery.
Pre-ejection period 6 weeks Modulation of impedance cardiography (ICG)-derived pre-ejection period (PEP) during rest, stress, and recovery.
Secretory IgA 6 weeks Modulation of immune activity as indicated by changes in salivary derived secretory immunoglobulin A (sIgA) levels at rest.
COMPASS-31 6 weeks Changes in self-reported autonomic function per the COMPASS-31 survey
PROMIS-29 6 weeks Changes in self-reported health related quality of life per the PROMIS-29 survey
PROMIS-Cog 8 6 weeks Changes in self-reported cognitive function per the PROMIS-Cognitive 8 survey
Perceived Stress Scale 6 weeks Changes in self-reported stress per the Perceived Stress Scale (PSS).
Trial Locations
- Locations (1)
Dr. Sid E. Williams Center for Chiropractic Research
🇺🇸Marietta, Georgia, United States