Study Information Guide

We appreciate your interest and look forward to working with you. This study is being conducted through Auburn University by Dr. Jennifer Robinson.  This document will help you understand the different components of the study. It is important that you read this document carefully. We also provide a checklist at the end of the document that you may wish to print off and hang somewhere that you frequent often (i.e., on the refrigerator, or on your door). Should you have any questions, concerns, or issues as you progress through the study, please do not hesitate to reach out to us at [email protected].

Importantly, this is a double-blind study. This means that both you and the research team do not know what study material you have. You will either receive 90 capsules of the placebo (216mg microcellulose) or 90 capsules of the “active” which is 216mg of calcium fructoborate (CFB).

There are two main parts to this study:

• Assessment Days
• Daily Check-ins

Before you begin…

This study will last 90 days (3 months) and you can do the study from home. No travel or visits to a clinic are required. You would be expected to be available for prescheduled online assessments regarding your progress. All study materials and assistance will be provided. You can earn up to $300 in exchange for your full and faithful participation. Before you begin the study, you will be asked to stop taking pain relievers and anti-inflammatories for 2 weeks. We will also ask that you try to refrain from taking anti-inflammatories and pain relievers throughout the study. However, if your pain becomes unbearable, you will be supplied with a ‘rescue medication’ which is 500mg of acetaminophen.

Assessment Days

In order to determine whether the calcium fructoborate (CFB) supplement works, we will have you complete questionnaires that ask about your joint pain. These assessments will be completed periodically over the entire course of the study. They typically take 20-30 minutes to complete. We will ask you to complete these assessments on the baseline day of your choosing, and on days 5, 14, 21, 28, 60, and 90.

These assessment should be completed prior to taking your study material.  We ask that you wake up as you normally do, but that you do not eat or drink anything other than water prior to completing the assessments. We also ask that you do not exercise or smoke/vape prior to taking the assessments. Finally, we ask that you do not take any anti-inflammatories or pain relievers 48 hours prior to the assessment days.

Daily Check-ins

“Daily Check-ins” will be conducted through a smartphone app called MetricWire.  You will receive an email from the study team inviting you to the study, with links to download MetricWire from the App Store (Mac) or Google Play Store (Android). We will use MetricWire to securely send you daily text reminders and surveys. If you complete >75% of the daily surveys, you will receive $75.

When you sign-up for MetricWire, we will send you a test survey to be sure you understand how to use the app. You should not start taking the study material until you receive an email from [email protected] or a text from a member of the research team confirming your study start date. 72 hours within completing the study, you will receive an email with confirmation of your study participation and how much money you earned. Payment information will then be sent to administration for processing. Please allow 4-6 weeks for delivery. If you do not receive your payment in that time period, please email us at [email protected] and we will be happy to assist.

Rescue Medication

You may experience joint pain throughout the study. If the pain becomes unbearable, you can take a “rescue medication”. The rescue medication will be acetaminophen (500mg/tablet), and we ask that should you need to use it, that you limit the dosage to 1000mg/day. We would ask that you discontinue use of the rescue medication as soon as your discomfort has subsided. You will be asked to refrain from taking anti-inflammatory and pain relief medications for 2 weeks prior to starting the study. We will also ask you to refrain from using the rescue medication within 48 hours prior to the questionnaires administered on days 5, 14, 21, 28, 60, and 90. We will inquire about rescue medication usage on our daily MetricWire check-ins.