ImmunoBoost: Lymphatic Osteopathic Manipulative Treatment Protocol
Lymphatic Osteopathic Manipulative Treatment Protocol for Healthy Individuals: A Crossover Self-Controlled Clinical Trial
This study will test whether a 15-minute lymphatic osteopathic treatment, compared with light sham touch or a short exercise session, changes immune blood markers in healthy adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Western University of Health Sciences Academic / other |
| Locations | 2 sites (Pomona, California and 1 other locations) |
| Trial ID | NCT06565065 on ClinicalTrials.gov |
What this trial studies
This randomized, crossover trial enrolls 30 healthy adults who will each receive three 15-minute interventions (lymphatic osteopathic manipulative treatment, sham light touch, and a brief exercise session) across separate visits. Blood samples will be taken at multiple time points around each visit to measure complete blood counts and circulating immune signaling molecules. Each participant serves as their own control and intervention order is randomized to reduce order effects. The goal is to compare immediate and short-term changes in immune cells and signaling to distinguish effects of OMT from those of light touch or exercise, building on prior human, animal, and in vitro findings.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 or older with BMI under 30 who are not immunocompromised, are infection-free, not pregnant or breastfeeding, not on immune-altering medications, and can tolerate brief moderate activity.
Not a fit: People who are immunocompromised, have autoimmune disease, recent major spleen or oncologic surgery, current infection, recent bodywork (OMT, massage, acupuncture, PT, chiropractic), are pregnant or breastfeeding, or who exceed BMI limits may not benefit or be eligible.
Why it matters
Potential benefit: If successful, this could identify a simple, nonpharmacologic approach to temporarily boost immune readiness in healthy people.
How similar studies have performed: Small human studies with OMT paired with COVID-19 and Hepatitis B vaccinations and supporting animal and in vitro work have suggested immune enhancement, but evidence is limited and not definitive.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Individuals must be 18 years or older. * Individuals must provide informed consent. * Individuals must be healthy with a BMI under 30, with no primary or secondary immune deficiency or autoimmune disease/must not be immunocompromised. * Individuals must not be using or recently have used any immune-altering medications such as corticosteroids, cyclosporin, tacrolimus, and pimecrolimus * Individuals must not have had lymphatic OMT or other physical manipulation such as acupuncture, physical therapy, chiropractic, or massage therapy in the previous four weeks before study enrollment. * Individuals must have the ability to receive OMT with lymphatic techniques. * Individuals must be able to tolerate 12 minutes of moderate physical activity. * Individuals must not be pregnant or breastfeeding. * Individuals must not have had a splenectomy or other spleen or oncologic surgery within the past 6 months. * Individuals must be infection-free for the past 6 weeks before starting the study and have not received any immunizations within the past 6 weeks. * Individuals must be willing to avoid strenuous activity at least 24 hours before each visit. * Individuals must be willing to abstain from moderate to intense activity in the 4 hours between their 2nd blood draw and their final blood draw at each of their three visits. Exclusion Criteria: * Individuals are younger than 18 years of age. * Individuals who do not provide informed consent. * Individuals with a BMI over 30, or with primary or secondary immune deficiency or autoimmune disease or is immunocompromised. * Individuals using or recently have used any immune-altering medications such as corticosteroids, cyclosporin, tacrolimus, and pimecrolimus * Individuals who have had lymphatic OMT or other physical manipulation such as acupuncture, physical therapy, chiropractic, or massage therapy in the previous four weeks before study enrollment. * Individuals who don't have the ability to receive OMT with lymphatic techniques. * Individuals who cannot tolerate 12 minutes of moderate physical activity. * Individuals who are pregnant or breastfeeding. * Individuals who have had a splenectomy or other spleen or oncologic surgery within the past 6 months. * Individuals who have had an infection in the 6 weeks before starting the study and or have received any immunizations within the past 6 weeks. * Individuals not willing to avoid strenuous activity at least 24 hours before each visit. * Individuals not willing to abstain from moderate to intense activity in the 4 hours between their 2nd blood draw and their final blood draw at each of their three visits.
Where this trial is running
Pomona, California and 1 other locations
- Western University of Health Sciences — Pomona, California, United States (Not_yet_recruiting)
- Western University of Health Sciences — Pomona, California, United States (Recruiting)
Study contacts
- Principal investigator: Brian Loveless, DO — Professor of NMM/OMM and Chief Medical Officer of WesternU Health
- Study coordinator: Brian Loveless, DO
- Email: bloveless@westernu.edu
- Phone: 909-469-8223
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.