Clinical Trial: NEM® Brand Eggshell Membrane Versus Placebo on Exercise-induced Joint Pain, Stiffness, & Cartilage Turnover

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Evaluation of the Effects of NEM® Brand Eggshell Membrane Versus Placebo on Exercise-induced Joint Pain, Stiffness, & Cartilage Turnover in Healthy, Post-menopaus

Brief Summary: This study is intended to evaluate the effect of the dietary supplement NEM® brand eggshell membrane versus placebo in reducing exercise-induced joint pain & stiffness & cartilage turnover in healthy post-menopausal women. Half of the study participants will receive NEM, once daily, orally while the other half of the study participants will receive placebo, once daily, orally.

Detailed Summary: 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 NEM® brand eggshell membrane can alleviate joint pain or stiffness, either directly following exercise or 12 hours post-exercise versus placebo. The study will also evaluate NEM's effect, if any, 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 50 steps per leg utilizing an aerobics step at the clinical site. They will follow this exercise regimen on alternating days for 2 weeks. Changes in pain & stiffness (immediate & 12-hour) will be compared to both baseline and to the placebo group. Blood & Urine samples will also be collected at baseline and at the end of Week 1 & Week 2. The change in CTX-II will be compared to baseline.
Sponsor: ESM Technologies, LLC

Current Primary Outcome: 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.


Original Primary Outcome: Exercise-induced Joint Pain [ 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.


Current Secondary Outcome:

  • 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.


Original Secondary Outcome:

  • Exercise-induced Joint Stiffness [ 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.
  • Exercise-induced Cartilage Turnover [ Time Frame: 2 weeks ]
    To evaluate the efficacy of NEM® versus placebo at reducing exercise-induced cartilage turnover in healthy, post-menopausal women.


Information By: ESM Technologies, LLC

Dates:
Date Received: April 22, 2016
Date Started: December 2015
Date Completion:
Last Updated: February 6, 2017
Last Verified: February 2017