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
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.
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.
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 →ESM Technologies, LLC is the lead sponsor of 13 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
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.
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, 500 mg, #0 capsule, + placebo oil, 1,500 mg, softgels, once daily orally for 2 weeks
Dietary Supplement: Placebo
Dietary supplement combination for the support of joint health.
Placebo
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
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
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
Plan to share: No
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.
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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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