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CompletedNCT04215198Move3Updated Apr 30, 2024

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

An interventional study of Move3™ (NEM® brand eggshell membrane + KD PUR® brand fish oil) and Placebo in Exercise-induced Joint Pain, Exercise-induced Joint Stiffness and Exercise-induced Joint Cartilage Turnover, sponsored by ESM Technologies, LLC. Completed at 1 site in United States. Open to participants aged 40 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-30.

Sponsored by ESM Technologies, LLC · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Sep 2018, registered Dec 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
85
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

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Keywords

  • exercise-induced
  • joint pain
  • joint stiffness
  • cartilage turnover
  • CTX-II
  • exercise recovery
03

In context

Arthralgia

281 studies on the registry are indexed under Arthralgia; 43 are open to participants now.

This study's enrollment of 85 is above the median of 70 across 225 interventional studies indexed under Arthralgia.

Browse Arthralgia studies →

Lead sponsor

ESM Technologies, LLC is the lead sponsor of 13 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
85 participants (actual)

Study arms

  • Experimental
    Move3™ (NEM + fish oil)

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

    Dietary Supplement: Move3™ (NEM® brand eggshell membrane + KD PUR® brand fish oil)

  • Placebo comparator
    Placebo

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

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementMove3™ (NEM® brand eggshell membrane + KD PUR® brand fish oil)

    Dietary supplement combination for the support of joint health.

  • Dietary supplementPlacebo

    Placebo

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 weeks

Secondary outcomes

  1. 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).

    Time frame: 2 weeks

  2. 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).

    Time frame: 2 weeks

07

Study locations

1 site
  • QPS Bio-Kinetic
    Springfield, Missouri 65802, United States
08

References and documents

Publications

  • Ruff KJ, Morton K, Duncan SA, Back M, Ismail A, Ryan AS. Eggshell Membrane+Fish Oil Combination (Move3®) Reduces Exercise-Induced Joint Pain, Stiffness and Cartilage Turnover in Healthy Adults: Results from a Randomized, Double-Blind, Placebo-Controlled Study. Int J Phys Med Rehabil (2020) 8:551.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2018 to primary completion in Jan 2019, 3 months.

Of 96 interventional studies with no phase under Arthralgia, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 35. This study's 3 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 30, 2019
First posted
Jan 2, 2020
StartActual
Sep 20, 2018
Primary completionActual
Jan 16, 2019
CompletionActual
Jan 16, 2019
Last update
Apr 30, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04215198
Lead sponsor
ESM Technologies, LLC
Collaborators
KD Pharma Group, QPS Bio-Kinetic
Responsible party
Sponsor
First posted
Jan 2, 2020
Start date
Sep 20, 2018
Primary completion
Jan 16, 2019
Completion
Jan 16, 2019
Last update
Apr 30, 2024

Study contacts

Kevin Ruff, Ph.D.
study director · ESM Technologies, LLC
Kayce Morton, D.O.
principal investigator · QPS Bio-Kinetic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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