NEM® Versus Placebo on Exercise-induced Joint Pain, Stiffness, & Cartilage Turnover In Healthy, Post-Menopausal Women
|ClinicalTrials.gov Identifier: NCT02751944|
Recruitment Status : Completed
First Posted : April 26, 2016
Last Update Posted : August 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Exercise-induced Joint Pain Stiffness and Cartilage Turnover||Dietary Supplement: NEM Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Evaluation of the Effects of NEM® Brand Eggshell Membrane Versus Placebo on Exercise-induced Joint Pain, Stiffness, & Cartilage Turnover in Healthy, Post-menopausal Women|
|Study Start Date :||December 2015|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
Experimental: NEM Treatment
NEM, 500 mg, once daily, orally for 2 weeks
Dietary Supplement: NEM
Dietary supplement for the support of joint health.
Other Name: Natural Eggshell Membrane
Placebo Comparator: Placebo
Placebo, 500 mg, once daily, orally for 2 weeks
Dietary Supplement: Placebo
- Exercise-induced Cartilage Turnover via CTX-II Biomarker [ Time Frame: 2 weeks ]To evaluate the efficacy of NEM® versus placebo at reducing exercise-induced cartilage turnover in healthy, post-menopausal women by evaluating the change in urinary CTX-II levels.
- Exercise-induced Joint Pain via questionnaire [ Time Frame: 2 weeks ]To evaluate the efficacy of NEM® versus placebo at reducing exercise-induced knee discomfort (pain/aching) based upon perceived pain rated on a 10 point Likert scale.
- Exercise-induced Joint Stiffness via questionnaire [ Time Frame: 2 weeks ]To evaluate the efficacy of NEM® versus placebo at reducing exercise-induced knee stiffness based upon perceived stiffness rated on a 10 point Likert scale.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02751944
|Principal Investigator:||Dennis Morrison, D.O.||QPS-Biokinetic|
|Study Director:||Kevin J Ruff, Ph.D., MBA||ESM Technologies, LLC|