Effect of OMM on Anandamide Levels in Saliva

Osteopathic Manipulative Lymphatic Pump Technique and Its Effects to the Endocannabinoid System Activity as Measured by AEA Levels Via Mass Spectrometry and Mood Analogue Scale

The Investigators will be studying the effects of Osteopathic Manipulative Lymphatic Pump Treatment on levels of anandamide in Saliva. A qualitative scale will also be used to measure the canabinomimetic effects of osteopathic treatment.

Study Overview

• Status: Completed
• Conditions: Endocannabinoids; Anandamide
• Intervention / Treatment: Other: Osteopathic Manipulative Medicine

Detailed Description

The Endocannabinoid System is a signaling system composed of: 2 G-Protein coupled receptors (CB1 and CB2), substances acting on the cannabinoid receptors, and the enzymes and proteins involved in regulating endocannabinoids in tissue and at the receptors. The substances acting the cannabinoid receptors CB1 and CB2 are called endocannabinoids. The present study examines the effects of Osteopathic Manipulative Lymphatic Pump Techniques on levels of anandamide, an endocannabinoid, in saliva samples of adult subjects. Based on existing research, the investigators hypothesize that subjects who undergo osteopathic lymphatic treatment will have increased levels of anandamide. Establishing the levels of endocannabinoids in these subjects will allow for a direct measure of the efficacy of the Osteopathic Manipulative Lymphatic techniques. In addition to the quantification of endocannabinoid levels in saliva, a series of 16, 100 mm analog scales will be used to assess the cannabinomimetic effects in the subject pre and post OMM treatment/control and it will be correlated to changes in endocannabinoid levels.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Old Westbury, New York, United States, 11568
      • NYITCOM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Accepts healthy volunteers.
• Able to read and understand scale for survey.
• BMI (Body Mass Index) TBD- BMI between 18 and 25 kg/m2 Signed informed consent No exercising on the day of or day before the appointment Age 18 and above.

Exclusion Criteria:

• smoker
• Neuropsychiatric disorders
• Autoimmune Disorders
• Unavailable 8AM-12PM
• No Illicit drug use, including exogenous cannabis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Osteopathic Manipulative Medicine; The thoracic inlet release, The Miller Thoracic Pump, Pedal Pump will be performed. These techniques are gentle and would be rhythmic in motion.

Other: Osteopathic Manipulative Medicine; The procedures are picked for their generalized effect on the lymphatic system based on osteopathic literature and research. Our goal is to mobilize the lymphatic fluid to induce an increase of endocannabinoids. These procedures are similar to mechanical motion seen in exercise in regards to lymphatic movement. Each technique will be performed for a total of four minutes each

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Osteopathic Manipulative Lymphatic Pump Treatment and Its Relationship To Anandamide levels	The Investigators will be studying the effects of Osteopathic Manipulative Lymphatic Pump Treatment on levels of anandamide in Saliva. A qualitative scale will also be used to measure the canabinomimetic effects of osteopathic treatment.	60 minutes

Collaborators and Investigators

• Sponsor: New York Institute of Technology
• Collaborators: Cold Spring Harbor Laboratory
• Investigators: Principal Investigator: George Cheriyan, DO, NYIT-COM

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2015
• Primary Completion (ACTUAL): August 1, 2016
• Study Completion (ACTUAL): September 1, 2017

Study Registration Dates

• First Submitted: January 19, 2016
• First Submitted That Met QC Criteria: March 29, 2016
• First Posted (ESTIMATE): April 4, 2016

Study Record Updates

• Last Update Posted (ACTUAL): October 5, 2017
• Last Update Submitted That Met QC Criteria: October 3, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Healthy
• Other Study ID Numbers: BHS-1152

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No