Chiropractic Care for Abdominal Obesity

(OBE Trial)

Recruiting at 1 trial location

Overseen By Ron Hosek, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Life University

Must not be taking: Short-acting benzodiazepines

Disqualifiers: Chiropractic care, Syncope disorders, Heart conditions, Thought disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 6 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that if you are taking prescription medications, you must be on a stable dose for at least 6 weeks and not plan to change medications or doses during the study. If you are taking short-acting benzodiazepines like midazolam or triazolam, you cannot participate.

How is chiropractic care different from other treatments for abdominal obesity?

Chiropractic care, which involves spinal manipulation and adjustments, is unique because it focuses on aligning the spine to potentially improve overall body function, unlike other treatments that primarily target diet, exercise, or medication. This approach is novel for abdominal obesity as it does not directly address fat reduction but may influence body systems in a holistic manner. ^{1 2 3 4 5}

Research Team

Tyson Perez, DC, PhD

Principal Investigator

Life University

Eligibility Criteria

This trial is for individuals with high central adiposity, which means they carry excess fat in the abdominal area. The study aims to include people who are likely experiencing related health issues like stress, cognitive problems, and immune system irregularities.

Inclusion Criteria

I've been on the same prescription meds, except for short-acting benzodiazepines, for at least 12 weeks with no changes planned.

I can walk by myself on a treadmill.

My waist is at least 35 inches (if female) or 40 inches (if male).

Exclusion Criteria

I have been diagnosed with rheumatoid arthritis, osteoporosis, or cervical spine instability.

Hearing impairment (cognitive task uses auditory stimuli)

I have a condition that causes me to faint when I stand up.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessments including measurements of height, weight, waist circumference, and various physiological and cognitive tests

1 week

1 visit (in-person)

Treatment

Participants receive 6 weeks of chiropractic adjustments from community-based clinicians

6 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of immune markers, cognitive function, and self-reported health

4 weeks

Treatment Details

Interventions

• Chiropractic

Trial Overview The trial is exploring whether chiropractic care can improve health outcomes related to psychoneuroimmunology (PNI) in those with abdominal obesity. This includes looking at stress levels, brain function, nervous system balance, and immune response.

Participant Groups

Group I: Chiropractic care Experimental Treatment 1 Intervention

6 weeks of chiropractic care

Chiropractic is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Chiropractic Care for:

• Back pain
• Neck pain
• Headaches
• Musculoskeletal disorders

Approved in Canada as Chiropractic Treatment for:

• Musculoskeletal and nervous system disorders
• Back pain
• Neck pain
• Headaches

Approved in European Union as Chiropractic Therapy for:

• Musculoskeletal disorders
• Back pain
• Neck pain
• Headaches

Who Is Running the Clinical Trial?

Life University

Lead Sponsor

Trials

21

Recruited

450+

University of Georgia

Collaborator

Trials

109

Recruited

43,500+

Findings from Research

In a study of 40 obese women, acupuncture treatment over 5 weeks led to significant weight loss and reductions in insulin and leptin levels compared to a sham treatment.

Acupuncture also resulted in increased levels of ghrelin and cholecystokinin (CCK), suggesting it may help regulate appetite and energy balance through hormonal changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of acupuncture on leptin, ghrelin, insulin and cholecystokinin in obese women: a randomised, sham-controlled preliminary trial. Güçel, F., Bahar, B., Demirtas, C., et al.[2022]

Increased cardiovascular risk from abdominal obesity is mainly linked to higher levels of free fatty acids, suggesting that managing these levels could reduce health risks.

Effective strategies to lower free fatty acid levels include adopting a very-low-fat, low-glycemic-index diet, enhancing insulin sensitivity through exercise and certain supplements, and using anti-lipolytic agents, which can also help promote a healthier body composition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction of free fatty acids may ameliorate risk factors associated with abdominal obesity. McCarty, MF.[2019]

Diacylglycerol oil, acupuncture, and hypnosis are the only complementary therapies with evidence supporting their effectiveness in treating obesity.

These therapies should be considered as additional support to traditional methods like calorie restriction and exercise, rather than standalone treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complementary and alternative therapies for weight loss. Steyer, TE., Ables, A.[2009]

A systematic review of 15 studies involving 2918 participants found that non-surgical interventions for abdominal obesity led to an average waist circumference reduction of -2.65 cm, indicating moderate efficacy.

Behavioral interventions alone reduced waist circumference by -1.88 cm, while combined interventions (behavioral plus dietary and/or physical activity) achieved a greater reduction of -4.11 cm, suggesting that multi-faceted approaches may be more effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic Treatment for Abdominal Obesity in Adults. Kesztyüs, D., Erhardt, J., Schönsteiner, D., et al.[2019]

Auricular acupressure using vaccaria seeds significantly reduced body weight, abdominal circumference, and body mass index in 58 adult women with abdominal obesity over an 8-week period.

Participants in the experimental group also experienced a decrease in triglyceride levels, indicating potential metabolic benefits alongside weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effects of Auricular Acupressure on Obesity in Women with Abdominal Obesity]. Cha, HS., Park, H.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Influence of acupuncture on leptin, ghrelin, insulin and cholecystokinin in obese women: a randomised, sham-controlled preliminary trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Reduction of free fatty acids may ameliorate risk factors associated with abdominal obesity. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Complementary and alternative therapies for weight loss. [2009]

4. Germany pubmed.ncbi.nlm.nih.gov

Therapeutic Treatment for Abdominal Obesity in Adults. [2019]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

[Effects of Auricular Acupressure on Obesity in Women with Abdominal Obesity]. [2022]