The Effects of Chiropractic in a Population With High Central Adiposity

Abdominal Obesity Clinical Trial

— OBE  

Official title:

Psychoneuroimmunology as a Framework for Studying the Effects of Chiropractic Care in a Population With High Central Adiposity: a Feasibility Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06208163
• Other study ID #: I-0027
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 15, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Life University
• Contact: Austin Garlinghouse
• Phone: 770-426-2639
• Email: research.studies[@]life.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Able to provide informed consent

• 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

• If taking prescription medications other than short-acting benzodiazepines, on a stable dose for a minimum of 12 weeks with no plans to change medications or doses during the study

• Able to walk unassisted on a treadmill

Exclusion Criteria:

• Prescribed short-acting benzodiazepines which include midazolam & triazolam

• 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

• Chronic pain rated higher than 3/10 on a visual analog scale (VAS)

• Oral injury, inflammation, or disease that causes the mouth or gums to bleed easily

Related Conditions & MeSH terms

• Abdominal Obesity
• Obesity, Abdominal

Intervention

Procedure:
• Chiropractic
Chiropractic spinal adjustments

Locations

Country	Name	City	State
United States	Dr. Sid E. Williams Center for Chiropractic Research	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Life University	University of Georgia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant recruitment	Average number of participants recruited/enrolled per month	6 months (recruitment period)
Primary	Participant scheduling	Average time lag between first lab assessment & first chiropractic visit	6.5 months (recruitment period + two weeks)
Primary	Participant compliance	% of participants violating 1 or more pre-assessment lifestyle restrictions & unable/unwilling to be rescheduled	7.5 months (through study completion)
Primary	Participant adherence	% of participants not attending at least 80% of their chiropractic sessions	7.5 months (through study completion)
Primary	Participant tolerability	% of participants unable/unwilling to complete a given assessment	7.5 months (through study completion)
Primary	Participant retention	% of participants completing the trial	7.5 months (through study completion)
Primary	Assessment acceptability	Most common participant-rated acceptability score for each assessment process/procedure	7.5 months (through study completion)
Primary	Intervention acceptability	Most common participant-rated acceptability score for each aspect of the chiropractic care	7.5 months (through study completion)
Primary	Data fidelity	% of acquisitions from a given assessment that are unsuitable for analysis	7.5 months (through study completion)
Primary	Implementation acceptability	Most common clinician-rated acceptability score for each trial process/procedure	7.5 months (through study completion)