Clinical trial NCT06208163: The Effects of Chiropractic in a Population With High Central Adiposity
Official title: Psychoneuroimmunology as a Framework for Studying the Effects of Chiropractic Care in a Population With High Central Adiposity: a Feasibility Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Abdominal Obesity
Keywords: abdominal obesity
adults
psychoneuroimmunology
chiropractic
Lead sponsor: Life University
Sponsor class: OTHER
Collaborators: name: University of Georgia
First posted: 2024-01-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recruitment
timeFrame: up to 6 months
measure: Efficiency
timeFrame: 6 weeks
measure: Latency
timeFrame: 6 weeks
measure: Compliance
timeFrame: 6 weeks
measure: Adherence
timeFrame: 6 weeks
measure: Tolerability
timeFrame: 6 weeks
measure: Retention
timeFrame: 6 weeks
measure: Acceptability
timeFrame: 6 weeks
measure: Data quality
timeFrame: 6 weeks
Secondary outcomes:
measure: Cognitive Flexibility
timeFrame: 6 weeks
measure: Gait
timeFrame: 6 weeks
measure: Heart rate variability
timeFrame: 6 weeks
measure: Pre-ejection period
timeFrame: 6 weeks
measure: Secretory IgA
timeFrame: 6 weeks
measure: COMPASS-31
timeFrame: 6 weeks
measure: PROMIS-29
timeFrame: 6 weeks
measure: PROMIS-Cog 8
timeFrame: 6 weeks
measure: Perceived Stress Scale
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Marietta
country: United States
facility: Dr. Sid E. Williams Center for Chiropractic Research
state: Georgia
Study officials:
affiliation: Life University
name: Tyson Perez, DC, PhD
role: PRINCIPAL_INVESTIGATOR
References: