Recruiting

Observational Study

Sponsor:

Auburn University

Code:

NCT05438979

Conditions

Effect of Drug

Eligibility Criteria

Sex: All

Age: 40 - 65

Healthy Volunteers: Accepted

Interventions

Placebo

Calcium Fructoborate

Study Details

Brief summary:

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.

Conditions

Effect of Drug

Study ID

NCT05438979

Start date

Jul 1, 2022

Status verified date

Aug, 2023

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Jun 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 65

Healthy Volunteers: Accepted

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 Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

The placebo will be a simple microcellulose, which is generally-recognized-as-safe (GRAS) and commonly used in food products.

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.

Interventions

Placebo

Placebo for comparison to CFB

Calcium Fructoborate

216mg CFB

Primary outcome measure

  • WOMAC Assessment [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Jennifer L Robinson, Ph.D.

3345212177jointhealthstudy@gmail.com

Locations

Auburn University

Recruiting

Auburn, Alabama, United States, 36849

Contacts

Jennifer L Robinson, Ph.D.

334-521-2177jointhealthstudy@gmail.com

More Information

Sponsor

Auburn University

Last update posted

Aug 16, 2023

Last verified

Aug, 2023

Keywords

  • calcium fructoborate
  • virtual study
  • joint pain
  • knee pain
  • internet
  • joint health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Auburn University on 2023-08-16.