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Behavioural Intervention

Osteopathic Manipulative Treatment for Immune Boosting in Healthy Adults

N/A

Waitlist Available

Led By Brian Loveless, DO

Research Sponsored by Western University of Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Individuals must be 18 years or older

Individuals must be healthy with a BMI under 30, with no primary or secondary immune deficiency or autoimmune disease, and must not be immunocompromised

Must not have

Individuals with a BMI over 30, or with primary or secondary immune deficiency or autoimmune disease, or are immunocompromised

Individuals who cannot tolerate 12 minutes of moderate physical activity

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 5 minutes post-intervention to 4 hours post-intervention.

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if osteopathic manipulative treatment (OMT) can boost the immune system in healthy adults compared to a fake light treatment or exercise. They will measure immune cells and signaling molecules

Who is the study for?

This trial is for healthy adults interested in how different treatments might affect their immune system. Participants will be involved in three separate sessions, each including a unique treatment: osteopathic manipulative treatment (OMT), sham light touch, or exercise. They must complete a physical activity survey and agree to blood draws during visits.

What is being tested?

The study tests the impact of OMT on immune readiness compared to exercise and sham light touch by measuring changes in blood cells and immune signals at multiple times after these treatments. Each participant experiences all three interventions across three visits.

What are the potential side effects?

Since this trial involves non-invasive procedures like OMT, sham light touch, and mild exercise with healthy individuals, significant side effects are not anticipated. However, minor discomfort from the blood draws may occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am healthy, my BMI is under 30, and I do not have immune or autoimmune conditions.

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I haven't had infections or vaccinations in the last 6 weeks.

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I can do moderate exercise for 12 minutes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a BMI over 30, or an immune system condition.

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I cannot do moderate exercise for 12 minutes.

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I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 5 minutes post-intervention to 4 hours post-intervention.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 5 minutes post-intervention to 4 hours post-intervention.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 5 minutes post-intervention to 4 hours post-intervention. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Complete Blood Count (CBC) with differential

Secondary study objectives

Evaluation of safety based on reported adverse events

Pro-Inflammatory cytokine profiling

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Order 3 - Day 0: Exercise, Week 3: OMT, Week 6: ShamExperimental Treatment3 Interventions

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.

Group II: Order 2 - Day 0: Sham, Week 3: OMT, Week 6: ExerciseExperimental Treatment3 Interventions

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.

Group III: Order 1 - Day 0: OMT, Week 3: Sham, Week 6: ExerciseExperimental Treatment3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Osteopathic Manipulative Treatment (OMT)

2021

Completed Phase 4

~400

0 / 7Eligibility criteria met