ImmunoBoost: The Lymphatic Osteopathic Manipulative Treatment Protocol Study
NCT Number: NCT06565065
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Healthy
Interventions: PROCEDURE: Osteopathic Manipulative Treatment (OMT)|OTHER: Sham Light Touch|OTHER: Exercise Protocol
Sponsor: Western University of Health Sciences
Collaborators: American Osteopathic Foundation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-08-26
Completion Date: 2025-12-30
Locations: Western University of Health Sciences, Pomona, California, 91766, United States

Summary:
The goal of this clinical trial is to determine whether osteopathic manipulative treatment (OMT) enhances immune system readiness in healthy adults compared to exercise or sham light treatment. Specifically, the goal of this study is to assess circulating immune cells and signaling molecules in the blood in response to these various treatments.

It aims to compare: Complete Blood Counts (CBC) and blood immune signaling molecule levels in healthy adults in response to OMT, sham light touch, and exercise, with measurements taken at multiple time points.

Researchers will compare immune blood cells and signaling molecules in response to OMT versus sham light touch and exercise within the same group of healthy adults measured at three time points for each of the three total visits.

Participants will do a 15-minute OMT session, a 15-minute light sham session, or a 15-minute exercise session at each of their three separate visits (they will do one of each over the course of their 3 appointments in random order). They will have three blood draws taken at each of those three visits. They will also fill out a Global Physical Activity Questionnaire (GPAQ) survey to assess their level of physical activity throughout the study.

Primary Outcome Measures: Complete Blood Count (CBC) with differential, CBC with differential will be evaluated to identify the number of circulating plasma leukocytes for each intervention for each of the three interventions at three time points for each visit/intervention. This test will help us identify levels of erythrocytes, platelets, and leukocytes, including neutrophils, lymphocytes, monocytes, eosinophils, and basophils. This will be compared across time points for OMT, sham treatment, and exercise., Baseline to 5 minutes post-intervention to 4 hours post-intervention.
Secondary Outcome Measures: Pro-Inflammatory cytokine profiling, V-Plex Human Proinflammatory Panel I (4-Plex) will be used to identify cytokine profiles, including including IL-6 (Interleukin-6), IL-1β (Interleukin-1 beta), INF-γ (Interferon-gamma), and TNF-α (Tumor Necrosis Factor-alpha). This will be evaluated for each of the three interventions at three time points for each visit/intervention. This will be compared across time points for OMT, sham treatment, and exercise., Baseline to 5 minutes post-intervention to 4 hours post-intervention.|Evaluation of safety based on reported adverse events, Documentation of any adverse events to OMT, sham treatment, or exercise protocol., Through study completion, an average of 6 weeks.