Joint Health Study

Last updated: August 15, 2023
Sponsor: Auburn University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Placebo

Calcium Fructoborate

Clinical Study ID

NCT05438979
22-151 CFB
  • Ages 40-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 thestudy and who are willing to make best efforts to refrain from use of same throughoutthe study
  9. Has reliable internet service;
  10. Some computer literacy;
  11. Has a smartphone; and
  12. Has a laptop, desktop computer, or iPad.

Exclusion

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;
  1. Participants medically diagnosed with rheumatoid arthritis; 7) Participants withcardiovascular diseases; 8) Participants with liver and/or kidney problems; 9) Participantswho are pregnant; 10) Health conditions that would prevent the participant fromsuccessfully 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 theenrollment in the study; 12) Physician prescribed use of pharmaceutical medications for OAor joint discomfort within 3 months prior to enrollment in this study; 13) Any joint injuryin the 6-months prior to the enrollment in the clinical trial; 14) Unreliable or nointernet access/service; 15) Unable to use a smartphone or lacking the computer literacyneeded to complete the study 16) No laptop, desktop, or iPad that would allow for thecompletion of the study tasks.

Study Design

Total Participants: 300
Treatment Group(s): 2
Primary Treatment: Placebo
Phase:
Study Start date:
July 01, 2022
Estimated Completion Date:
December 31, 2024

Study 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

Connect with a study center

  • Auburn University

    Auburn, Alabama 36849
    United States

    Active - Recruiting

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