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The Effects of Chiropractic in a Population With High Central Adiposity
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
🗓️ Study Start (Actual) 15 February 2024
🗓️ Primary Completion (Estimated) 30 September 2024
✅ Study Completion (Estimated) 31 December 2024
👥 Enrollment (Estimated) 20
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Atlanta, Georgia, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to 65 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 5 January 2024
  • First Submitted that Met QC Criteria 5 January 2024
  • First Posted 17 January 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 5 January 2024
  • Last Update Posted 17 January 2024
  • Last Verified January 2024