The Effects of Chiropractic in a Population With High Central Adiposity

NCT06208163 | Completed Results

• 1 other identifier: Perez_OBE_042224
• 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 (5)

• Proportion of Potential Participants Who Are Eligible.

  The number of adults attending the on-site screening who are eligible to participate, divided to the total number of adults attending the on-site screening. This assesses 'Eligibility'

  From lab arrival to completion of on-site screening (up to 15 minutes)

• Proportion of Participants Complying With Pre-baseline Lifestyle Restrictions

  The number of participants complying with 24hr and 3hr pre-baseline lifestyle restrictions, divided by the total number of participants. This assesses 'Compliance'.

  From start of lifestyle restriction window to lab arrival (up to 24 hours)

• Proportion of Participants Able to Tolerate the Assessments

  The number of participants able to complete baseline assessments as directed, divided by the total number of participants. This assesses 'Tolerability'.

  From enrollment to completion of baseline assessments (up to 2 hours)

• Proportion of Participants Adhering to Their Prescribed Care Plan

  The number of participants prescribed a chiropractic care plan that attended ≥80% of their chiropractic sessions, divided by the total number of participants prescribed a chiropractic care plan. This assesses 'Adherence'.

  From enrollment to end of treatment (up to 6 weeks)

• Proportion of Participants Retained in the Study

  Number of participants enrolled who attend the final assessment session, divided by the total number of participants enrolled. This assesses 'Retention'.

  From enrollment to end of treatment (up to 6 weeks)

Secondary Outcomes (8)

• Changes in COMPASS-31 Raw Scores

  Baseline, 2 weeks, 6 weeks

• Changes in PSS-10 T-scores

  Baseline, 2 weeks, 6 weeks

• Changes in PROMIS-Cog 8 T-scores

  Baseline, 2 weeks, 6 weeks

• Changes in PROMIS-29 Subscale T-scores

  Baseline, 2 weeks, 6 weeks

• Changes in PROMIS-29 Subscale Raw Scores

  Baseline, 2 weeks, 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

Study Sites (1)

Life University

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

Limitations and Caveats

Due to time and funding constraints, recruitment ended prior to achieving our target sample size (i.e., n=20).

Results Point of Contact

• Title: Tyson Perez, DC, PhD
• Organization: Life University

tyson.perez@life.edu

6783314527

Study Officials

• Tyson Perez, DC, PhD

  Life University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: January 17, 2024
• Study Start: November 11, 2024
• Primary Completion: September 4, 2025
• Study Completion: September 4, 2025
• Last Updated: May 8, 2026
• Results First Posted: May 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: (start date): within 1 year of study completion(end date): indefinitely
• Access Criteria: IPD, metadata \& analytic code necessary to reproduce results will be made publicly accessible via a data repository

Locations

US (1)