Joint Health Study

Study Overview
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Brief Summary
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Natural dietary health supplements that may improve quality of life by relieving joint discomfort have been of increasing interest. Recent studies have demonstrated promising effects of one such supplement - calcium fructoborate (CFB). Preliminary evidence suggests that CFB may reduce joint discomfort, however, few well-powered studies have been conducted to assess the true effects of this supplement. In this study, conducted virtually, we will examine changes in joint discomfort over a 90 day period. Participants will be randomized to receive either 216mg CFB or placebo (i.e., 216mg microcellulose) to take every day for the study period.

Detailed Description
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There has been increasing interest in natural dietary supplements other than glucosamine and/or chondroitin that may support healthy joints. Recent studies have demonstrated promising effects of calcium fructoborate (CFB), a generally-recognized-as-safe (GRAS) material and a key active ingredient in several commercially popular joint supplements, due to its potential to acutely as well as chronically improve symptoms of joint discomfort, possibly due to its anti-inflammatory properties. Clinical trials have demonstrated converging evidence that CFB improves joint health outcomes, but inadequate sample size has been a limiting factor of most studies to date, especially in terms of sub-domain and/or sub-group analyses within common joint pain/health inventories such as the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) and McGill Pain Questionnaire assessment tools. Here, we propose a higher N (N > 300) study to examine the long-term effects of a daily 216mg morning dose of CFB on measures of pain, discomfort, and quality of life. CFB has been marketed and consumed at this dosage for over 17 years with over 5 billion servings having been provided to people with no reported adverse events. Most recently, the European Food Safety Authority has deemed CFB safe for the adult population (excluding pregnant and lactating women due to lack of data) at levels up to 220mg/day (3.14mg/kg bodyweight per day). Participants will be randomized to receive either 216mg CFB or placebo (i.e., 216mg microcellulose) to take every day for 90 days. On the first, 5th, 14th, 21st, 28th, 60th, and 90th days, participants will take a check-in questionnaire via Qualtrics. The survey will be composed of questionnaires that broadly cover joint pain, activities of daily living, sleep, and general well-being. Compliance checks will be administered daily via the participant's smartphone using the application MetricWire. This study will be conducted in a double-blind fashion, such that the experimental team and the participants are unaware of group assignment (216mg CFB vs. placebo). Blinding information will be held by the study sponsor, VDF FutureCeuticals, Inc. Group assignment will be determined by stratified permuted block (a form of covariate-adaptive randomization) to equal group sizes, and equal distribution of males/females in each group

Official Title
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Auburn University Joint Health Study

Conditions
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Effect of Drug

Intervention / Treatment
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* Dietary Supplement: Placebo
* Dietary Supplement: Calcium Fructoborate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 40-65 years of age; Self-reported or medically diagnosed knee joint pain for > 3 months (chronic); Diagnosis of osteoarthritis of the knee; No diagnosed psychiatric or neurological condition; Not taking antibiotics; Not taking any other joint health supplement Not taking prescription medications for OA or joint discomfort for the last 3 months No use of NSAIDS or other pain relievers for two (2) weeks prior to enrollment in the study and who are willing to make best efforts to refrain from use of same throughout the study Has reliable internet service; Some computer literacy; Has a smartphone; and Has a laptop, desktop computer, or iPad. Exclusion Criteria: <40 or >65 years of age; Does not have osteoarthritis of the knee; Diabetes or other metabolic disorders; Inflammatory and/or infectious health conditions; 6) Participants medically diagnosed with rheumatoid arthritis; 7) Participants with cardiovascular diseases; 8) Participants with liver and/or kidney problems; 9) Participants who are pregnant; 10) Health conditions that would prevent the participant from successfully completing the study (i.e., motor control conditions such as Parkinson's; psychiatric conditions such as ADHD); 11) Use of antibiotics 1 month prior to the enrollment in the study; 12) Physician prescribed use of pharmaceutical medications for OA or joint discomfort within 3 months prior to enrollment in this study; 13) Any joint injury in the 6-months prior to the enrollment in the clinical trial; 14) Unreliable or no internet access/service; 15) Unable to use a smartphone or lacking the computer literacy needed to complete the study 16) No laptop, desktop, or iPad that would allow for the completion of the study tasks.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomly assigned to one of two groups - calcium fructoborate (CFB) or placebo.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>The placebo will be a simple microcellulose, which is generally-recognized-as-safe (GRAS) and commonly used in food products. | Dietary Supplement: Placebo<br>* Placebo for comparison to CFB<br>|
| Active Comparator: Calcium Fructoborate<br>Calcium Fructoborate (CFB), is a proprietary, safe generally-recognized-as-safe (GRAS) supplement. The only content of the supplement is CFB - there are no excipients, binders, or flow agents, nor are there any other materials. 216mg of CFB will be administered daily for 90 days. | Dietary Supplement: Calcium Fructoborate<br>* 216mg CFB<br>* Other names: CFB;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC Assessment | We will be administering the Western Ontario and McMaster Universities Osteoarthritis (WOMAC; scored 0-240 with higher scores indicating more discomfort) throughout the course of the study. We expect that WOMAC scores will change in as little as 5 days in the CFB group compared to the Placebo group. Furthermore, we hypothesize that these changes will persist throughout the entire 90 days for the CFB group. | The WOMAC is administered at baseline, and at days 5, 14, 21, 28, 60, and 90. | 
| McGill Pain Questionnaire | We will be administering the McGill Pain Questionnaire (scored 0-220, with higher scores indicating more discomfort) throughout the course of the study. We expect that McGill Pain Questionnaire scores will change in as little as 5 days in the CFB group compared to the Placebo group. Furthermore, we hypothesize that these changes will persist throughout the entire 90 days for the CFB group. | The McGill Pain Questionnaire is administered at baseline, and at days 5, 14, 21, 28, 60, and 90. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily Self-Reported Pain | The investigators will assess changes in self-reported pain a participant had on a daily basis for the entire duration of the study via a daily question asked using a smartphone application. This assessment will be based on a scale of 0-9 with higher scores indicating greater pain. | The daily pain question will be administered every day for the duration of the study (approximately 90 days) | 
| Daily Self-Reported Sleep | The investigators will assess changes in the amount of sleep a participant had on a daily basis for the entire duration of the study via a single daily question asking about the number of hours of sleep the participant had the night before. | The question will be administered daily for the duration of the study (approximately 90 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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calcium fructoborate, virtual study, joint pain, knee pain, internet, joint health