HealthyNCT06565065
ImmunoBoost: The Lymphatic Osteopathic Manipulative Treatment Protocol Study
A study testing Osteopathic Manipulative Treatment (OMT) and Exercise Protocol in people with Healthy, run by Western University of Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Osteopathic Manipulative Treatment (OMT) and Exercise Protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Western University of Health Sciences
Pomona, California, 91766
About this study
Official title: Lymphatic Osteopathic Manipulative Treatment Protocol for Healthy Individuals: A Crossover Self-Controlled Clinical Trial
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.
Read more
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.
Read the detailed description
This clinical trial is a follow-up on a recent trial demonstrating an enhanced immune response in participants who received lymphatic osteopathic manipulative treatment (OMT) with each of their COVID-19 mRNA vaccinations. Similar immune enhancement was observed in a pilot study with OMT in conjunction with the Hepatitis B vaccine. Additionally, animal studies have shown that lymphatic pump OMT can cause transient increases in the movement of lymphatic fluid, immune cells, and signaling molecules throughout the body and bloodstream. These findings were further supported by in vitro studies on fibroblasts, where OMT led to significant increases in circulating cytokines. There are studies that suggest that combining physical exercise with vaccination can also improve immune responses. To parse out these effects observed in OMT and exercise studies and provide the mechanisms underlying the observed immune enhancements, this clinical trial will be conducted.
This study is designed as a crossover, self-controlled, comparative effectiveness randomized clinical trial. A total of 30 healthy individuals who meet all inclusion/exclusion criteria will be recruited. Participants will then fill out a health questionnaire during the screening process to confirm their eligibility.
Each participant will be randomly assigned to one of three intervention sequences to maintain blinding and control for order and sequencing effects. The intervention sequences are as follows:
- Order 1: Day 0: OMT, Week 3: Sham, Week 6: Exercise
- Order 2: Day 0: Sham, Week 3: OMT, Week 6: Exercise
- Order 3: Day 0: Exercise, Week 3: OMT, Week 6: Sham
There will be a 3-week washout period between each intervention. Participants will complete the Global Physical Activity Questionnaire (GPAQ) survey to identify their current level of exercise at each visit. They will also be monitored for any adverse effects following each intervention.
All treatment protocols will be done for a 12-minute timeframe per session. Participants will have three blood draws at each visit: at baseline, five minutes after intervention, and four hours after intervention. The primary outcome measures will include cytokine levels and circulating leukocyte levels, which will be compared across the different intervention sequences.
This study aims to provide a deeper understanding of the mechanism by which lymphatic OMT alters the immune system. It will also compare these effects to the mechanisms of exercise.
- Conditions
- Healthy
- Being tested
- Osteopathic Manipulative Treatment (OMT), Sham Light Touch, Exercise Protocol
- Keywords
- Osteopathic Manipulative Treatment, Lymphatic Pump Treatment, Immune System, OMT, Complete Blood Count, Cytokines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Manipulative Treatment (OMT)Procedure or surgery
A full standardized lymphatic protocol will be performed, including thoracic inlet left and right, thoracoabdominal release, pelvic diaphragm release, pedal pump, splenic pump, and abdominal lymphatic pump. This treatment will be done by systematically working down and back up. The protocol will last a total of 12 minutes for each participant
Sham Light TouchOther
A full standardized 12-minute session in which treaters will mimic various osteopathic manipulative techniques at specific anatomical locations without applying pressure or manipulation.
Exercise ProtocolOther
A full standardized moderate-intensity physical activity as defined by the Centers for Disease Control (CDC). Target heart rate for moderate-intensity exercise should be between 64 and 76% of maximum heart rate. To estimate age-related heart rate, subjects' age will be subtracted from 220. Then, that number will be multiplied by 75%, which will be standardized across all subjects in the study. Heart rate will be monitored with the use of an attached pulse-ox monitor. Treadmill speed will be adjusted accordingly so that each subject maintains a heart rate of 75% of their maximum heart rate. A brisk walk will be done on a flat treadmill and no incline will be utilized. Subjects will be allowed a minute of warm-up to get to the appropriate pace/target heart rate.
| Study group | Role | What they receive |
|---|---|---|
| Order 1 - Day 0: OMT, Week 3: Sham, Week 6: Exercise | Experimental | Osteopathic Manipulative Treatment (OMT)
followed by a 3-week washout period and then:
Sham protocol
followed by a 3-week washout period and then:
Exercise protocol. Receives: Procedure: Osteopathic Manipulative Treatment (OMT); Other: Sham Light Touch; Other: Exercise Protocol |
| Order 2 - Day 0: Sham, Week 3: OMT, Week 6: Exercise | Experimental | Sham protocol
followed by a 3-week washout period and then:
Osteopathic Manipulative Treatment (OMT)
followed by a 3-week washout period and then:
Exercise protocol. Receives: Procedure: Osteopathic Manipulative Treatment (OMT); Other: Sham Light Touch; Other: Exercise Protocol |
| Order 3 - Day 0: Exercise, Week 3: OMT, Week 6: Sham | Experimental | Exercise protocol
followed by a 3-week washout period and then:
Osteopathic Manipulative Treatment (OMT)
followed by a 3-week washout period and then:
Sham protocol. Receives: Procedure: Osteopathic Manipulative Treatment (OMT); Other: Sham Light Touch; Other: Exercise Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 5 minutes post-intervention to 4 hours post-intervention.
Secondary outcomes (2)
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.
Measured: 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.
Measured: Through study completion, an average of 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start14 Jul 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- American Osteopathic Foundation
- Responsible party
- Principal investigator, Brian Loveless, Western University of Health Sciences
- Investigators
- Brian Loveless, DO, Principal investigator, Professor of NMM/OMM and Chief Medical Officer of WesternU Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06565065
- Sponsor's protocol ID
- P24/IRB/002
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2024
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lymphatic Osteopathic Manipulative Treatment Protocol for Healthy Individuals: A Crossover Self-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06565065
- Acronym / sponsor ID
- P24/IRB/002
- Conditions
- Healthy
- Keywords
- Osteopathic Manipulative Treatment, Lymphatic Pump Treatment, Immune System, OMT, Complete Blood Count, Cytokines
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Western University of Health SciencesUniversity, hospital or other
- Collaborators
- American Osteopathic Foundation
- Study start
- 14 Jul 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 21 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This clinical trial is a follow-up on a recent trial demonstrating an enhanced immune response in participants who received lymphatic osteopathic manipulative treatment (OMT) with each of their COVID-19 mRNA vaccinations. Similar immune enhancement was observed in a pilot study with OMT in conjunction with the Hepatitis B vaccine. Additionally, animal studies have shown that lymphatic pump OMT can cause transient increases in the movement of lymphatic fluid, immune cells, and signaling molecules throughout the body and bloodstream. These findings were further supported by in vitro studies on fibroblasts, where OMT led to significant increases in circulating cytokines. There are studies that suggest that combining physical exercise with vaccination can also improve immune responses. To parse out these effects observed in OMT and exercise studies and provide the mechanisms underlying the observed immune enhancements, this clinical trial will be conducted.
This study is designed as a crossover, self-controlled, comparative effectiveness randomized clinical trial. A total of 30 healthy individuals who meet all inclusion/exclusion criteria will be recruited. Participants will then fill out a health questionnaire during the screening process to confirm their eligibility.
Each participant will be randomly assigned to one of three intervention sequences to maintain blinding and control for order and sequencing effects. The intervention sequences are as follows:
- Order 1: Day 0: OMT, Week 3: Sham, Week 6: Exercise
- Order 2: Day 0: Sham, Week 3: OMT, Week 6: Exercise
- Order 3: Day 0: Exercise, Week 3: OMT, Week 6: Sham
There will be a 3-week washout period between each intervention. Participants will complete the Global Physical Activity Questionnaire (GPAQ) survey to identify their current level of exercise at each visit. They will also be monitored for any adverse effects following each intervention.
All treatment protocols will be done for a 12-minute timeframe per session. Participants will have three blood draws at each visit: at baseline, five minutes after intervention, and four hours after intervention. The primary outcome measures will include cytokine levels and circulating leukocyte levels, which will be compared across the different intervention sequences.
This study aims to provide a deeper understanding of the mechanism by which lymphatic OMT alters the immune system. It will also compare these effects to the mechanisms of exercise.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Order 1 - Day 0: OMT, Week 3: Sham, Week 6: Exercise | Experimental | Procedure: Osteopathic Manipulative Treatment (OMT), Other: Sham Light Touch, Other: Exercise ProtocolOsteopathic Manipulative Treatment (OMT) followed by a 3-week washout period and then: Sham protocol followed by a 3-week washout period and then: Exercise protocol. |
| Order 2 - Day 0: Sham, Week 3: OMT, Week 6: Exercise | Experimental | Procedure: Osteopathic Manipulative Treatment (OMT), Other: Sham Light Touch, Other: Exercise ProtocolSham protocol followed by a 3-week washout period and then: Osteopathic Manipulative Treatment (OMT) followed by a 3-week washout period and then: Exercise protocol. |
| Order 3 - Day 0: Exercise, Week 3: OMT, Week 6: Sham | Experimental | Procedure: Osteopathic Manipulative Treatment (OMT), Other: Sham Light Touch, Other: Exercise ProtocolExercise protocol followed by a 3-week washout period and then: Osteopathic Manipulative Treatment (OMT) followed by a 3-week washout period and then: Sham protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic Manipulative Treatment (OMT)A full standardized lymphatic protocol will be performed, including thoracic inlet left and right, thoracoabdominal release, pelvic diaphragm release, pedal pump, splenic pump, and abdominal lymphatic pump. This treatment will be done by systematically working down and back up. The protocol will last a total of 12 minutes for each participant | Procedure or surgery | Order 1 - Day 0: OMT, Week 3: Sham, Week 6: Exercise, Order 2 - Day 0: Sham, Week 3: OMT, Week 6: Exercise, Order 3 - Day 0: Exercise, Week 3: OMT, Week 6: Sham |
| Sham Light TouchA full standardized 12-minute session in which treaters will mimic various osteopathic manipulative techniques at specific anatomical locations without applying pressure or manipulation. | Other | Order 1 - Day 0: OMT, Week 3: Sham, Week 6: Exercise, Order 2 - Day 0: Sham, Week 3: OMT, Week 6: Exercise, Order 3 - Day 0: Exercise, Week 3: OMT, Week 6: Sham |
| Exercise ProtocolA full standardized moderate-intensity physical activity as defined by the Centers for Disease Control (CDC). Target heart rate for moderate-intensity exercise should be between 64 and 76% of maximum heart rate. To estimate age-related heart rate, subjects' age will be subtracted from 220. Then, that number will be multiplied by 75%, which will be standardized across all subjects in the study. Heart rate will be monitored with the use of an attached pulse-ox monitor. Treadmill speed will be adjusted accordingly so that each subject maintains a heart rate of 75% of their maximum heart rate. A brisk walk will be done on a flat treadmill and no incline will be utilized. Subjects will be allowed a minute of warm-up to get to the appropriate pace/target heart rate. | Other | Order 1 - Day 0: OMT, Week 3: Sham, Week 6: Exercise, Order 2 - Day 0: Sham, Week 3: OMT, Week 6: Exercise, Order 3 - Day 0: Exercise, Week 3: OMT, Week 6: Sham |
Primary outcome
Complete Blood Count (CBC) with differential
Time frame: Baseline to 5 minutes post-intervention to 4 hours post-intervention.
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.
2 secondary outcomes
Pro-Inflammatory cytokine profiling
Time frame: Baseline to 5 minutes post-intervention to 4 hours post-intervention.
Evaluation of safety based on reported adverse events
Time frame: Through study completion, an average of 6 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Loveless, DO principal investigator
Professor of NMM/OMM and Chief Medical Officer of WesternU Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic Manipulative Treatment (OMT) and Exercise Protocol in people with Healthy, run by Western University of Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Blood Count (CBC) with differential (time frame: Baseline to 5 minutes post-intervention to 4 hours post-intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.