Joint Health Study

August 15, 2023 updated by: Jennifer L. Robinson, Ph.D., Auburn University

Auburn University Joint Health Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Between 40-65 years of age;
  2. Self-reported or medically diagnosed knee joint pain for > 3 months (chronic);
  3. Diagnosis of osteoarthritis of the knee;
  4. No diagnosed psychiatric or neurological condition;
  5. Not taking antibiotics;
  6. Not taking any other joint health supplement
  7. Not taking prescription medications for OA or joint discomfort for the last 3 months
  8. 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
  9. Has reliable internet service;
  10. Some computer literacy;
  11. Has a smartphone; and
  12. Has a laptop, desktop computer, or iPad.

Exclusion Criteria:

  1. <40 or >65 years of age;
  2. Does not have osteoarthritis of the knee;
  3. Diabetes or other metabolic disorders;
  4. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
The placebo will be a simple microcellulose, which is generally-recognized-as-safe (GRAS) and commonly used in food products.
Dietary supplement: Placebo
Placebo for comparison to CFB
Active Comparator: Calcium Fructoborate
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
216mg CFB
Other Names:
  • CFB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WOMAC Assessment
Time Frame: The WOMAC is administered at baseline, and at days 5, 14, 21, 28, 60, and 90.
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
Time Frame: The McGill Pain Questionnaire is administered at baseline, and at days 5, 14, 21, 28, 60, and 90.
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
Time Frame: The daily pain question will be administered every day for the duration of the study (approximately 90 days)
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
Time Frame: The question will be administered daily for the duration of the study (approximately 90 days)
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)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compliance
Time Frame: Daily for the duration of the study (approximately 90 days)
The investigators will assess compliance via daily questionnaires delivered to the participant's smartphone. Compliance will be determined by affirmative responses to daily questions as to whether participants have taken their study materials. To calculate compliance, we will add all affirmative responses (out of 90) and divide by 90 (scale is from 0 (not compliant) to 1 (100% compliant)).
Daily for the duration of the study (approximately 90 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Auburn University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

June 1, 2022

First Submitted That Met QC Criteria

June 28, 2022

First Posted (Actual)

June 30, 2022

Study Record Updates

Last Update Posted (Actual)

August 16, 2023

Last Update Submitted That Met QC Criteria

August 15, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-151 CFB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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