The Effects of Chiropractic in a Population With High Central Adiposity (OBE)

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Life University

Status

Not yet enrolling

Conditions

Abdominal Obesity

Treatments

Procedure: Chiropractic

Study type

Interventional

Funder types

Other

Identifiers

NCT06208163
I-0027

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Chiropractic care
Experimental group
Description:
6 weeks of chiropractic care
Treatment:
Procedure: Chiropractic

Trial contacts and locations

1

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Central trial contact

Austin Garlinghouse

Data sourced from clinicaltrials.gov

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