The Effects of Chiropractic in a Population With High Central Adiposity

NCT ID: NCT06208163

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-04
• Study Completion Date: 2025-09-04

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.

Conditions

Abdominal Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chiropractic care

6 weeks of chiropractic care

Group Type: EXPERIMENTAL

Chiropractic

Intervention Type: PROCEDURE

Chiropractic spinal adjustments

Interventions

Chiropractic

Chiropractic spinal adjustments

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Georgia

OTHER

Sponsor Role: collaborator

Life University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tyson Perez, DC, PhD

Role: PRINCIPAL_INVESTIGATOR

Life University

Locations

Dr. Sid E. Williams Center for Chiropractic Research

Marietta, Georgia, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

I-0027

Identifier Type: -

Identifier Source: org_study_id