What We Did. And How We Did It.
Prior to commencing the study, all participants gave their informed consent. A total of 60 adults between the ages of 18 and 70 (45 men and 15 women; 40.2 ± 10.2 y; 78.6 ± 10.2 kg; see Table 1) agreed to participate.
Each reported chronic joint pain in one of the following joints: elbow, shoulder, ankle or knee joints. Participants were recruited online through a popular health and fitness community and data were collected through self reports in a distance-based capacity. Participants were also pre-screened to exclude those who had used any additional medications (methotrexate or immunosuppressants), NSAIDs, analgesics, or joint supplements (MSM, glucosamine or chondroitin) two weeks prior to the start of the study. Those with egg allergies, or who were pregnant or breastfeeding, were also excluded. Participants were asked to refrain from use of pain medications throughout the study period.
Demographics of both supplement and placebo groups
In order to participate, individuals had to be exercising regularly, at least three times per week. They were screened for their regular physical activity (reported 4.8 ± 1.1 exercise sessions/wk), and asked to ensure that both their exercise and nutritional regimens remained unchanged over the course of the study.
After matching for age, sex, and affected joint, participants (n=60) were randomly assigned to receive either the EM supplement (fast joint care+; FJC+), or a placebo supplement for 4 weeks. These groups did not differ significantly in terms of age or weight, contained similar numbers of men and women, and contained similar numbers of individuals with shoulder, elbow, knee, and ankle pain (see Table 1). All supplements were provided to subjects in identically marked containers, and all capsules (placebo and FJC+) were identical in appearance (color, flavor, size). All participants were instructed to take their “supplement” once per day, at the same time of day (i.e. first thing in the morning, with breakfast).
Each capsule of the FJC+ supplement contained 500mg of Gallus gallus (chicken) eggshell membrane extract (a commercial preparation sold as fast joint care+ by Genuine Health, Toronto, Ontario); additional non-medical ingredients included rice flour, magnesium stearate, gelatin, and water. The color and flavor matched placebo capsules contained only rice flour, magnesium stearate, gelatin, and water. The individual components of FJC+ were not quantified in the supplement as the product is intended to be used as a complete eggshell membrane extract, without additional ingredients (ie. additional glucosamine, chondroitin, etc.).
In addition to their normal exercise program, participants were asked to complete an additional exercise challenge once per week. This exercise challenge was to be completed on the same day of each week (Monday) and at the same time of day (in the morning, after supplementation and breakfast). The exercise challenge for those with chronic shoulder or elbow pain consisted of pushups. For those with chronic knee or ankle pain, the exercise challenge consisted of jump squats. Each of these sessions involved performing 10 sets of 5 repetitions of the given movement, with 2 minutes of rest between sets.
Immediately after each exercise challenge session, participants rated their specific joint pain on a Visual Analog Scale (VAS) at two time points: within 10 minutes of completing the challenge and 24 hours following the challenge. Compliance to the exercise programming and supplementation schedule was self-reported and logged by participants; those logs were provided to researchers weekly via email. Subjects were also asked to report any side effects during the trial.
Joint pain was assessed using a 100mm visual analog scale (VAS), and participants submitted this information via electronic form. A self-assessment was performed at the two time points (post-exercise, and next day after exercise) for each of the 4 weeks. Each subject was asked to “click on the line below to indicate how severe the pain is on the affected joint with 0 being no pain and 100 being pain as bad as it can be”. Responses were submitted electronically on a weekly basis, after each pair of assessments. VAS scores were then measured in millimeters from the left hand end of the scale to the point marked by the subject.
Data were collected across the 4 weeks of supplementation, and analyzed using a two-way ANOVA with repeated measures (i.e. MANOVA). In cases of significant interactions (p?0.05) post-hoc analysis was performed using Student's t-test for comparison between groups, and paired t-test for comparison within groups (JMP, SAS Institute Inc., Cary, NC). The VAS ratings were reported on a scale of 0 to 100, with 0 indicating no pain, and 100 representing greatest pain. Where appropriate, change scores were examined after adjusting absolute scores and then comparing between groups with a one-way analysis. All values are reported as mean ± SEM, and statistical significance was set at p ? 0.05.
To summarize the protocol in brief: During week 1 of the investigation, subjects took their first 500mg dose of FJC+ with breakfast on Monday. After breakfast they immediately performed their first exercise challenge and then rated their joint pain using the VAS described above. In addition, they rated their joint pain on Tuesday, 24h later. During each subsequent week, subjects repeated the same protocol, providing 4 weeks' worth of joint pain data, with week 1 serving as a baseline.