Calcium Fructoborate for Joint Discomfort

Overseen By Jennifer L Robinson, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Auburn University

Must not be taking: Antibiotics, NSAIDs, Pain relievers

Disqualifiers: Diabetes, Rheumatoid arthritis, Cardiovascular, others

Compensation: Varies

Number of Visits: 7

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a natural supplement, calcium fructoborate (CFB), can reduce joint discomfort, particularly in the knees. Participants will receive either the CFB supplement or a placebo (a harmless pill resembling the supplement) daily for 90 days. Ideal participants have experienced knee osteoarthritis and joint pain for more than three months, are not taking other joint health supplements, and can access the internet. As an unphased trial, this study provides a unique opportunity to contribute to the understanding of natural supplements for joint health.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any joint health supplements, prescription medications for osteoarthritis or joint discomfort, and pain relievers like NSAIDs for a certain period before joining the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that calcium fructoborate (CFB) is generally safe for people. In studies, participants taking CFB experienced no serious side effects. One study lasting 90 days found no harmful effects at the tested dose, indicating it did not damage the body. Another study found that CFB alleviated joint discomfort without causing serious health issues. These findings suggest that CFB is well-tolerated when taken daily. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Calcium Fructoborate is unique because it offers a natural, supplement-based approach to easing joint discomfort, which sets it apart from the typical anti-inflammatory drugs and pain relievers commonly used for this condition. Unlike standard treatments that often involve synthetic medications with potential side effects, Calcium Fructoborate is a generally recognized as safe (GRAS) supplement that exclusively contains the active ingredient without any additional fillers. Researchers are excited about its potential because it provides a simple, natural alternative that could reduce joint discomfort over a 90-day period without the use of pharmaceuticals.

What evidence suggests that calcium fructoborate might be an effective treatment for joint discomfort?

Research has shown that calcium fructoborate (CFB), which participants in this trial may receive, might help reduce joint pain. One study found that people experienced improved knee function and comfort after just two weeks of taking CFB. Another study reported that taking CFB for 90 days enhanced knee movement and comfort. These findings suggest that CFB could ease joint pain. Although more research is needed, early results are promising for those with joint problems. Participants in this trial may also receive a placebo, consisting of simple microcellulose, to compare the effects. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for people aged 40-65 with knee osteoarthritis and chronic knee pain, who haven't taken antibiotics or joint discomfort drugs recently. Participants need basic computer skills, a smartphone, and reliable internet to join the virtual study but can't have certain health conditions like cardiovascular diseases or diabetes.

Inclusion Criteria

I have had knee pain for more than 3 months.

You should have basic computer skills.

I haven't taken NSAIDs or pain relievers for 2 weeks and can avoid them during the study.

Exclusion Criteria

I have an ongoing infection or inflammation.

I have been prescribed medication for joint pain or osteoarthritis in the last 3 months.

I have diabetes or another metabolic disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either 216mg CFB or placebo daily for 90 days. Check-in questionnaires are administered on days 1, 5, 14, 21, 28, 60, and 90.

12 weeks

7 virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Calcium Fructoborate
• Placebo

Trial Overview The study tests if Calcium Fructoborate (CFB), a dietary supplement, can relieve joint discomfort over 90 days compared to a placebo. Participants will be randomly assigned to take either CFB or an inactive substance daily in this virtually conducted trial.

How Is the Trial Designed?

Group I: Calcium Fructoborate Active Control 1 Intervention

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.

Group II: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Auburn University

Lead Sponsor

Trials

81

Recruited

14,600+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4051624/

Short-term efficacy of calcium fructoborate on subjects with ... This comparative double-blind study has confirmed the effect of CFB, showing significant improvements in knee discomfort and function over a period of 2 weeks.

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05438979?draw=2&rank=1

Study Details | NCT05438979 | Joint Health Study Recent studies have demonstrated promising effects of one such supplement - calcium fructoborate (CFB). Preliminary evidence suggests that CFB may reduce joint ...

3. jarlife.net jarlife.net/4535-effects-of-once-daily-versus-twice-daily-dosing-of-calcium-fructoborate-on-knee-discomfort-a-90-day-double-blind-placebo-controlled-randomized-clinical-study.html

EFFECTS OF ONCE-DAILY VERSUS TWICE ... Our previous research showed that calcium fructoborate significantly improved knee comfort 9, 14, 15) and flexibility through a self-reported ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/24940052/

Short-term Efficacy of Calcium Fructoborate on Subjects ... Calcium fructoborate (CFB) at a dose of 110 mg twice per day was previously reported to improve knee discomfort during the first 14 days of treatment.

5. withpower.com withpower.com/trial/phase-effect-of-drugs-6-2022-dbdbf

Calcium Fructoborate for Joint Discomfort Trial Overview The study tests if Calcium Fructoborate (CFB), a dietary supplement, can relieve joint discomfort over 90 days compared to a placebo.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0278691516302010

Subchronic and genetic safety evaluation of a calcium ... A 90 day subchronic toxicology study revealed no adverse toxicologic findings at appropriate safety levels were observed.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3241914/

A Double-Blind, Placebo-Controlled Pilot Study to Evaluate ... No serious adverse events were reported. The calcium fructoborate showed beneficial effect on the inflammatory markers for all groups subjected ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4930945/

Calcium Fructoborate for Bone and Cardiovascular Health It provides effective and safe support against the discomfort and lack ... There were three groups involved in the study of joint discomfort: the first ...