Chiropractic Care for Abdominal Obesity

(OBE Trial)

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether chiropractic care (also known as spinal manipulation or chiropractic adjustment) can improve mental and physical well-being in individuals with significant belly fat. Researchers aim to determine if this treatment can reduce stress and enhance cognitive skills and immune system health. Participants will receive six weeks of chiropractic care to assess its impact. Suitable candidates have a body mass index (BMI) of 30 or higher and a waist size of at least 35 inches for women or 40 inches for men. As an unphased trial, this study provides a unique opportunity to explore the potential health benefits of chiropractic care in a supportive research environment.

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.

What prior data suggests that chiropractic care is safe for treating abdominal obesity?

Research has shown that chiropractic care, which often involves spinal adjustments, is generally safe for most people. Studies have found it can be as effective as other recommended treatments for certain issues, such as low back pain. Importantly, no strong evidence links chiropractic care to serious harm, like a tear in a neck artery.

Most people tolerate chiropractic treatments well, with minor side effects like temporary soreness being the most common. For those considering joining a trial for chiropractic care, these findings suggest it is a reasonably safe option. Always consult a healthcare provider about any concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Chiropractic care is unique in addressing abdominal obesity because it offers a non-invasive alternative to traditional treatments like medication or surgery. Unlike most weight loss strategies that focus on diet, exercise, or pharmaceuticals, chiropractic care may help by improving spinal alignment, which can potentially enhance the body's metabolic processes and overall function. Researchers are excited about this treatment because it could offer a holistic approach to managing obesity, potentially reducing the reliance on medications that can have side effects. Additionally, chiropractic care is generally well-tolerated and could be an appealing option for those seeking a more natural path to health improvement.

What evidence suggests that chiropractic care might be an effective treatment for abdominal obesity?

Studies have shown that chiropractic care, often involving spinal adjustments, can address various physical issues. For instance, it effectively manages long-term lower back pain, suggesting potential benefits for reducing discomfort elsewhere in the body. Some research indicates that chiropractic treatments can enhance stress levels and overall physical function. Although limited data exists on chiropractic care's impact on belly fat, its success in relieving pain and improving movement in other conditions suggests potential benefits. This trial will explore whether chiropractic care could help with stress and immune function, often linked to high levels of belly fat. ^{1 4 6 7 8}

Who Is on the Research Team?

Tyson Perez, DC, PhD

Principal Investigator

Life University

Are You a Good Fit for This Trial?

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.

Body mass index (BMI) at least 30

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8915715/

Clinical Effectiveness and Efficacy of Chiropractic Spinal ... The key search terms used for efficacy and effectiveness studies were: “spinal manipulation,” “spinal manipulative therapy,” “manual therapy,” “chiropractic” ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3699243/

The Outcomes of Manipulation or Mobilization Therapy ... Summary of outcomes in CoE II studies comparing manipulative or mobilization therapy to physical therapy or physiotherapy or exercise in patients with chronic ...

3. systematicreviewsjournal.biomedcentral.com systematicreviewsjournal.biomedcentral.com/articles/10.1186/s13643-025-02855-7

Efficacy and safety of spinal manipulative therapy in the ... Spinal manipulative therapy (SMT) is frequently used to manage neck pain; however, its efficacy and safety in treating acute neck pain (ANP) ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0965229920318835

Effectiveness of osteopathic interventions in chronic non ... Osteopathic manipulative treatment (OMT) typically involve a wide range of manual techniques, which may include soft tissue stretching, joints manipulation ...

5. bmj.com bmj.com/content/364/bmj.l689

Benefits and harms of spinal manipulative therapy for the ... Objective To assess the benefits and harms of spinal manipulative therapy (SMT) for the treatment of chronic low back pain. Design Systematic ...

6. ccjm.org ccjm.org/content/92/9/550

Collaborative musculoskeletal care: The role for chiropractors Spinal manipulative therapy as an isolated intervention has been shown to be as effective as other guideline-recommended treatments and more ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S088539240700783X

Review Article Chiropractic: A Critical Evaluation The medical literature does not support a clear causal relationship between chiropractic manipulative therapy and internal carotid artery dissection.

8. cleveland.edu cleveland.edu/wp-content/uploads/2022/08/F4CP.Chiropractic.Safe-and-Cost-Effective-Approach-to-Health-2022-07-29-WEB.pdf

A SAFE AND COST-EFFECTIVE APPROACH TO HEALTH Treating structural imbalances in the body through spinal manipulative therapy performed by a DC is often a safer and far more effective way to manage pain, as ...