The Effects of Chiropractic in a Population With High Central Adiposity

NCT06208163 | Completed

• 1 other identifier: I-0027
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Obesity

Keywords

abdominal obesity; adults; psychoneuroimmunology; chiropractic

Outcome Measures

Primary Outcomes (9)

• Recruitment

  Average number of participants recruited/enrolled per month

  up to 6 months

• Efficiency

  Average battery duration

  6 weeks

• Latency

  Average time between first lab assessment \& first chiropractic session

  6 weeks

• Compliance

  proportion of participants complying with pre-assessment lifestyle restrictions

  6 weeks

• Adherence

  proportion of participants attending ≥80% of their chiropractic sessions

  6 weeks

• Tolerability

  % of participants able to complete a given assessment

  6 weeks

• Retention

  proportion of participants completing the trial

  6 weeks

• Acceptability

  proportion of participant-rated \& clinician-rated acceptability scores ≥3 in each domain

  6 weeks

• Data quality

  % of acquisitions from a given assessment that are suitable for analysis

  6 weeks

Secondary Outcomes (9)

• Cognitive Flexibility

  6 weeks

• Gait

  6 weeks

• Heart rate variability

  6 weeks

• Pre-ejection period

  6 weeks

• Secretory IgA

  6 weeks

Study Arms (1)

Chiropractic care

EXPERIMENTAL

6 weeks of chiropractic care

Procedure: Chiropractic

Interventions

Chiropractic PROCEDURE

Chiropractic spinal adjustments

Chiropractic care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• Body mass index (BMI) at least 30
• Waist circumference at least 35 inches if female or 40 inches if male

You may not qualify if:

• 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

Sponsors & Collaborators

• Life University: lead
• University of Georgia: collaborator

Study Sites (1)

Dr. Sid E. Williams Center for Chiropractic Research

Marietta, Georgia, 30067, United States

Location

MeSH Terms

Conditions

Obesity, Abdominal

Interventions

Manipulation, Chiropractic

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics

Study Officials

• Tyson Perez, DC, PhD

  Life University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: January 17, 2024
• Study Start: November 4, 2024
• Primary Completion: September 4, 2025
• Study Completion: September 4, 2025
• Last Updated: October 1, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)