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NEM® + KD PUR® Fish Oil Versus Placebo in Exercised-induced Joint Pain, Stiffness, & Cartilage Turnover in Healthy Men & Women (Move3)

Primary Purpose

Exercise-induced Joint Pain, Exercise-induced Joint Stiffness, Exercise-induced Joint Cartilage Turnover

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Move3™ (NEM® brand eggshell membrane + KD PUR® brand fish oil)
Placebo
Sponsored by
ESM Technologies, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Exercise-induced Joint Pain focused on measuring exercise-induced, joint pain, joint stiffness, cartilage turnover, CTX-II, exercise recovery

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Male or Female subjects must be 40-75 years of age at the time of Screening.
  2. Subjects must not have been diagnosed with a JCT disease (i.e. osteoarthritis, rheumatoid arthritis, spondyloarthritis, bursitis, gout, systemic lupus erythematosus, fibromyalgia, etc.) affecting the hip, knee, or ankle by a licensed physician prior to enrollment evaluation / screening.
  3. Subjects must have a resting pain/discomfort score of ≤ 2 on the 10-point continuous scale in the knee with the most severe pain/discomfort at the Follow-Up Screening/Baseline (first exercise visit).
  4. Subjects must be willing and healthy enough, as judged by the clinical Investigator or Sub-Investigator(s), to perform moderate exercise.
  5. Subjects must be available for and willing to attend all evaluation visits.
  6. Subjects must be able and willing to give informed consent.
  7. Subjects must be willing to use only acetaminophen as rescue pain medication, if needed.
  8. Subjects participating in prior studies evaluating eggshell membrane, curcumin, fish oil or collagen can participate in the present study so long as they are not currently taking an eggshell membrane, fish oil, curcumin, or collagen supplement and have not done so for 60 days prior to screening.

Exclusion Criteria:

  1. Subject is currently receiving therapy with remission-inducing drugs (i.e. methotrexate, TNF biologics, etc.), immunosuppressive drugs (i.e. corticosteroids, transplantation medications, etc.) or planning to use these products during the study period.
  2. Subject has been diagnosed with any clinically significant confounding inflammatory disease or condition that would interfere with the study evaluation, as judged by the clinical investigator (i.e. pseudo gout, Paget's disease, chronic pain syndrome, active rheumatic fever, etc.).
  3. Subject has known allergy to any of the investigational products, including but not limited to eggs or egg products, fish or fish products, corn or corn oil, and rice or rice flour. If any subject becomes sensitive during the study, they will immediately be excluded from continuing in the study.
  4. Subject suffers from clinically significant cardiac, pulmonary, or other complications that would prevent them from performing moderate exercise or could pose a risk to the subject's health, as judged by the clinical investigator.
  5. Subject participates in activities involving intensive use of the lower extremities (i.e. running / jogging, sports, bicycling, dancing, etc.) 2 or more days per week or participates in activities that involve moderate use of the lower extremities (i.e. walking, golfing, yoga, etc.) 3 or more days per week.
  6. Subject's body weight is greater than 300 pounds (136.1 kg) at the time of Screening.
  7. Subject is currently taking or is unwilling to forgo the use of prescription, over-the-counter (OTC) treatments, and/or dietary supplements affecting joint health within 30 days prior to baseline evaluation and for the duration of the study. Prohibited medications include: NSAIDs, analgesics (other than acetaminophen), opioids, anti-depressants (of all drug classes for this indication, including but not limited to SSRI's such as citalopram and fluoxetine, TCA's such as amitriptyline and amoxapine, SNRI's such as duloxetine or SNRI's used for fibromyalgia such as milnacipran and NDRI's such as bupropion), other medications for the management of painful conditions (i.e. fibromyalgia) including gabapentin and tizanidine & joint supplements. Examples of these types of medications are: aspirin, ibuprofen, naproxen, oxycodone, propoxyphene, diclofenac, celecoxib, amitriptyline, duloxetine, glucosamine, chondroitin, MSM, white willow bark, turmeric or curcumin, Boswellia, fish oil, etc.

    a. Washout Periods: Subjects are eligible to participate in the study following a 7-day washout period for opioids, a 14-day washout period for analgesics & NSAIDs, and a 90-day washout period for steroids, anti-depressants, or JCT dietary supplements (i.e. glucosamine, chondroitin, MSM, etc.) Acetaminophen must not have been taken within 24 hours of the first baseline evaluation.

  8. Subject is involved in any other research study involving an investigational product (drug, device or biologic) or a new application of an approved product, within 30 days of the first baseline evaluation.
  9. Pregnant and breastfeeding women, or women who intend to become pregnant during the course of the study.
  10. Subject has a history or positive test result of HIV, hepatitis B or hepatitis C.

Sites / Locations

  • QPS Bio-Kinetic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Move3™ (NEM + fish oil)

Placebo

Arm Description

NEM, 500 mg, #0 capsule, + fish oil, 1,500 mg, softgels, once daily orally for 2 weeks

Placebo, 500 mg, #0 capsule, + placebo oil, 1,500 mg, softgels, once daily orally for 2 weeks

Outcomes

Primary Outcome Measures

Exercise-induced Cartilage Turnover via CTX-II Biomarker
To evaluate the efficacy of Move3™ versus placebo at reducing exercise-induced cartilage turnover in healthy men & women by evaluating the change in urinary CTX-II levels.

Secondary Outcome Measures

Exercise-induced Joint Pain via questionnaire
To evaluate the efficacy of Move3™ versus placebo at reducing exercise-induced knee discomfort (pain/aching) based upon perceived pain rated on a 0-10 point continuous scale (where 0 = no pain).
Exercise-induced Joint Stiffness via questionnaire
To evaluate the efficacy of Move3™ versus placebo at reducing exercise-induced knee stiffness based upon perceived stiffness rated on a 0-10 point continuous scale (where 0 = no stiffness).

Full Information

First Posted
December 30, 2019
Last Updated
December 30, 2019
Sponsor
ESM Technologies, LLC
Collaborators
KD Pharma Group, QPS Bio-Kinetic
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1. Study Identification

Unique Protocol Identification Number
NCT04215198
Brief Title
NEM® + KD PUR® Fish Oil Versus Placebo in Exercised-induced Joint Pain, Stiffness, & Cartilage Turnover in Healthy Men & Women
Acronym
Move3
Official Title
Efficacy of the NEM® Brand Eggshell Membrane + KD PUR® Brand Fish Oil Combination (Move3™) Versus Placebo in Exercised-induced Joint Pain, Stiffness, & Cartilage Turnover in Healthy Men & Women
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
September 20, 2018 (Actual)
Primary Completion Date
January 16, 2019 (Actual)
Study Completion Date
January 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ESM Technologies, LLC
Collaborators
KD Pharma Group, QPS Bio-Kinetic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is intended to evaluate the effect of the dietary supplement combination of NEM® brand eggshell membrane + KD PUR® brand fish oil versus placebo in reducing exercise-induced joint pain, stiffness & cartilage turnover in healthy men & women. Half of the study participants will receive NEM + fish oil, once daily, orally while the other half of the study participants will receive placebo, once daily, orally while performing an exercise regimen every other day for two weeks.
Detailed Description
Moderate exercise can induce discomfort in joints when done infrequently or when done too intensely or for too long a period. This discomfort is often realized as either pain or stiffness in the joint that was the focus of the exercise. For example, one's knees will hurt after jogging for several miles, particularly if jogging for the first time. This study is intended to evaluate whether the combination of NEM® brand eggshell membrane + KD PUR® brand fish oil, commercially available as Move3™ can alleviate joint pain or stiffness, either directly following exercise or 12 hours post-exercise versus placebo. The study will also evaluate Move3's effect, on cartilage turnover via the cartilage degradation biomarker c-terminal cross-linked telopeptide of type II collagen (CTX-II). Participants will perform a minimum of 40 steps per leg utilizing an aerobics step at the clinical site. They will follow this exercise regimen on alternating days for 2 consecutive weeks. Changes in pain & stiffness (immediate & 12-hour) will be compared to both baseline and to the placebo group. Urine samples will also be collected at baseline and at the end of Week 1 & Week 2. The change in CTX-II from baseline will be compared to the placebo group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise-induced Joint Pain, Exercise-induced Joint Stiffness, Exercise-induced Joint Cartilage Turnover
Keywords
exercise-induced, joint pain, joint stiffness, cartilage turnover, CTX-II, exercise recovery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
treatment versus placebo
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Move3™ (NEM + fish oil)
Arm Type
Experimental
Arm Description
NEM, 500 mg, #0 capsule, + fish oil, 1,500 mg, softgels, once daily orally for 2 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, 500 mg, #0 capsule, + placebo oil, 1,500 mg, softgels, once daily orally for 2 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Move3™ (NEM® brand eggshell membrane + KD PUR® brand fish oil)
Intervention Description
Dietary supplement combination for the support of joint health.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Exercise-induced Cartilage Turnover via CTX-II Biomarker
Description
To evaluate the efficacy of Move3™ versus placebo at reducing exercise-induced cartilage turnover in healthy men & women by evaluating the change in urinary CTX-II levels.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Exercise-induced Joint Pain via questionnaire
Description
To evaluate the efficacy of Move3™ versus placebo at reducing exercise-induced knee discomfort (pain/aching) based upon perceived pain rated on a 0-10 point continuous scale (where 0 = no pain).
Time Frame
2 weeks
Title
Exercise-induced Joint Stiffness via questionnaire
Description
To evaluate the efficacy of Move3™ versus placebo at reducing exercise-induced knee stiffness based upon perceived stiffness rated on a 0-10 point continuous scale (where 0 = no stiffness).
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male or Female subjects must be 40-75 years of age at the time of Screening. Subjects must not have been diagnosed with a JCT disease (i.e. osteoarthritis, rheumatoid arthritis, spondyloarthritis, bursitis, gout, systemic lupus erythematosus, fibromyalgia, etc.) affecting the hip, knee, or ankle by a licensed physician prior to enrollment evaluation / screening. Subjects must have a resting pain/discomfort score of ≤ 2 on the 10-point continuous scale in the knee with the most severe pain/discomfort at the Follow-Up Screening/Baseline (first exercise visit). Subjects must be willing and healthy enough, as judged by the clinical Investigator or Sub-Investigator(s), to perform moderate exercise. Subjects must be available for and willing to attend all evaluation visits. Subjects must be able and willing to give informed consent. Subjects must be willing to use only acetaminophen as rescue pain medication, if needed. Subjects participating in prior studies evaluating eggshell membrane, curcumin, fish oil or collagen can participate in the present study so long as they are not currently taking an eggshell membrane, fish oil, curcumin, or collagen supplement and have not done so for 60 days prior to screening. Exclusion Criteria: Subject is currently receiving therapy with remission-inducing drugs (i.e. methotrexate, TNF biologics, etc.), immunosuppressive drugs (i.e. corticosteroids, transplantation medications, etc.) or planning to use these products during the study period. Subject has been diagnosed with any clinically significant confounding inflammatory disease or condition that would interfere with the study evaluation, as judged by the clinical investigator (i.e. pseudo gout, Paget's disease, chronic pain syndrome, active rheumatic fever, etc.). Subject has known allergy to any of the investigational products, including but not limited to eggs or egg products, fish or fish products, corn or corn oil, and rice or rice flour. If any subject becomes sensitive during the study, they will immediately be excluded from continuing in the study. Subject suffers from clinically significant cardiac, pulmonary, or other complications that would prevent them from performing moderate exercise or could pose a risk to the subject's health, as judged by the clinical investigator. Subject participates in activities involving intensive use of the lower extremities (i.e. running / jogging, sports, bicycling, dancing, etc.) 2 or more days per week or participates in activities that involve moderate use of the lower extremities (i.e. walking, golfing, yoga, etc.) 3 or more days per week. Subject's body weight is greater than 300 pounds (136.1 kg) at the time of Screening. Subject is currently taking or is unwilling to forgo the use of prescription, over-the-counter (OTC) treatments, and/or dietary supplements affecting joint health within 30 days prior to baseline evaluation and for the duration of the study. Prohibited medications include: NSAIDs, analgesics (other than acetaminophen), opioids, anti-depressants (of all drug classes for this indication, including but not limited to SSRI's such as citalopram and fluoxetine, TCA's such as amitriptyline and amoxapine, SNRI's such as duloxetine or SNRI's used for fibromyalgia such as milnacipran and NDRI's such as bupropion), other medications for the management of painful conditions (i.e. fibromyalgia) including gabapentin and tizanidine & joint supplements. Examples of these types of medications are: aspirin, ibuprofen, naproxen, oxycodone, propoxyphene, diclofenac, celecoxib, amitriptyline, duloxetine, glucosamine, chondroitin, MSM, white willow bark, turmeric or curcumin, Boswellia, fish oil, etc. a. Washout Periods: Subjects are eligible to participate in the study following a 7-day washout period for opioids, a 14-day washout period for analgesics & NSAIDs, and a 90-day washout period for steroids, anti-depressants, or JCT dietary supplements (i.e. glucosamine, chondroitin, MSM, etc.) Acetaminophen must not have been taken within 24 hours of the first baseline evaluation. Subject is involved in any other research study involving an investigational product (drug, device or biologic) or a new application of an approved product, within 30 days of the first baseline evaluation. Pregnant and breastfeeding women, or women who intend to become pregnant during the course of the study. Subject has a history or positive test result of HIV, hepatitis B or hepatitis C.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Ruff, Ph.D.
Organizational Affiliation
ESM Technologies, LLC
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kayce Morton, D.O.
Organizational Affiliation
QPS Bio-Kinetic
Official's Role
Principal Investigator
Facility Information:
Facility Name
QPS Bio-Kinetic
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65802
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

NEM® + KD PUR® Fish Oil Versus Placebo in Exercised-induced Joint Pain, Stiffness, & Cartilage Turnover in Healthy Men & Women

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