The Effects of Chiropractic in a Population with High Central Adiposity

Last updated: February 17, 2025
Sponsor: Life University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Obesity

Treatment

Chiropractic

Clinical Study ID

NCT06208163
I-0027
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 ona stable dose for a minimum of 6 weeks with plans to change medications or dosesduring 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 mechanicalfunction 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 uncontrolledor 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

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Chiropractic
Phase:
Study Start date:
November 04, 2024
Estimated Completion Date:
July 31, 2025

Study 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.

Connect with a study center

  • Dr. Sid E. Williams Center for Chiropractic Research

    Atlanta, Georgia 30308
    United States

    Site Not Available

  • Dr. Sid E. Williams Center for Chiropractic Research

    Marietta, Georgia 30067
    United States

    Active - Recruiting

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