Joint Health Study

NCT05438979 | Unknown

• 1 other identifier: 22-151 CFB
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Daily Self-Reported Pain

  The daily pain question will be administered every day for the duration of the study (approximately 90 days)

• Daily Self-Reported Sleep

  The question will be administered daily for the duration of the study (approximately 90 days)

Other Outcomes (1)

• Compliance

  Daily for the duration of the study (approximately 90 days)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Calcium Fructoborate

ACTIVE COMPARATOR

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

Interventions

Placebo DIETARY_SUPPLEMENT

Placebo for comparison to CFB

Placebo

Calcium Fructoborate DIETARY_SUPPLEMENT

216mg CFB

Also known as: CFB

Calcium Fructoborate

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \<40 or \>65 years of age;
• Does not have osteoarthritis of the knee;
• Diabetes or other metabolic disorders;
• Inflammatory and/or infectious health conditions;
• \) 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.

Sponsors & Collaborators

• Auburn University: lead

Study Sites (1)

Auburn University

Auburn, Alabama, 36849, United States

RECRUITING

Related Publications (12)

• Mogosanu GD, Bita A, Bejenaru LE, Bejenaru C, Croitoru O, Rau G, Rogoveanu OC, Florescu DN, Neamtu J, Scorei ID, Scorei RI. Calcium Fructoborate for Bone and Cardiovascular Health. Biol Trace Elem Res. 2016 Aug;172(2):277-281. doi: 10.1007/s12011-015-0590-2. Epub 2015 Dec 21.

  PMID: 26686846 BACKGROUND

• Pietrzkowski Z, Phelan MJ, Keller R, Shu C, Argumedo R, Reyes-Izquierdo T. Short-term efficacy of calcium fructoborate on subjects with knee discomfort: a comparative, double-blind, placebo-controlled clinical study. Clin Interv Aging. 2014 Jun 5;9:895-9. doi: 10.2147/CIA.S64590. eCollection 2014.

  PMID: 24940052 BACKGROUND

• Price AK, de Godoy MRC, Harper TA, Knap KE, Joslyn S, Pietrzkowski Z, Cross BK, Detweiler KB, Swanson KS. Effects of dietary calcium fructoborate supplementation on joint comfort and flexibility and serum inflammatory markers in dogs with osteoarthritis. J Anim Sci. 2017 Jul;95(7):2907-2916. doi: 10.2527/jas.2017.1588.

  PMID: 28727103 BACKGROUND

• Scorei ID, Scorei RI. Calcium fructoborate helps control inflammation associated with diminished bone health. Biol Trace Elem Res. 2013 Dec;155(3):315-21. doi: 10.1007/s12011-013-9800-y. Epub 2013 Aug 28.

  PMID: 23982445 BACKGROUND

• Scorei R, Cimpoiasu VM, Iordachescu D. In vitro evaluation of the antioxidant activity of calcium fructoborate. Biol Trace Elem Res. 2005 Nov;107(2):127-34. doi: 10.1385/BTER:107:2:127.

  PMID: 16217137 BACKGROUND

• Scorei RI, Ciofrangeanu C, Ion R, Cimpean A, Galateanu B, Mitran V, Iordachescu D. In vitro effects of calcium fructoborate upon production of inflammatory mediators by LPS-stimulated RAW 264.7 macrophages. Biol Trace Elem Res. 2010 Jun;135(1-3):334-44. doi: 10.1007/s12011-009-8488-5. Epub 2009 Aug 11.

  PMID: 19669712 BACKGROUND

• Scorei RI, Rotaru P. Calcium fructoborate--potential anti-inflammatory agent. Biol Trace Elem Res. 2011 Dec;143(3):1223-38. doi: 10.1007/s12011-011-8972-6. Epub 2011 Jan 28.

  PMID: 21274653 BACKGROUND

• Scorei R, Mitrut P, Petrisor I, Scorei I. A double-blind, placebo-controlled pilot study to evaluate the effect of calcium fructoborate on systemic inflammation and dyslipidemia markers for middle-aged people with primary osteoarthritis. Biol Trace Elem Res. 2011 Dec;144(1-3):253-63. doi: 10.1007/s12011-011-9083-0. Epub 2011 May 24.

  PMID: 21607703 BACKGROUND

• EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA); Turck D, Castenmiller J, De Henauw S, Hirsch-Ernst KI, Kearney J, Maciuk A, Mangelsdorf I, McArdle HJ, Naska A, Pelaez C, Pentieva K, Siani A, Thies F, Tsabouri S, Vinceti M, Cubadda F, Frenzel T, Heinonen M, Marchelli R, Neuhauser-Berthold M, Poulsen M, Maradona MP, Schlatter JR, van Loveren H, Rossi A, Knutsen HK. Safety of calcium fructoborate as a novel food pursuant to Regulation (EU) 2015/2283. EFSA J. 2021 Jul 5;19(7):e06661. doi: 10.2903/j.efsa.2021.6661. eCollection 2021 Jul.

  PMID: 34257728 BACKGROUND

• Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988 Dec;15(12):1833-40.

  PMID: 3068365 BACKGROUND

• Melzack R. The McGill Pain Questionnaire: major properties and scoring methods. Pain. 1975 Sep;1(3):277-299. doi: 10.1016/0304-3959(75)90044-5.

  PMID: 1235985 BACKGROUND

• Dworkin RH, Turk DC, Revicki DA, Harding G, Coyne KS, Peirce-Sandner S, Bhagwat D, Everton D, Burke LB, Cowan P, Farrar JT, Hertz S, Max MB, Rappaport BA, Melzack R. Development and initial validation of an expanded and revised version of the Short-form McGill Pain Questionnaire (SF-MPQ-2). Pain. 2009 Jul;144(1-2):35-42. doi: 10.1016/j.pain.2009.02.007. Epub 2009 Apr 7.

  PMID: 19356853 BACKGROUND

MeSH Terms

Conditions

Arthralgia

Interventions

calcium fructoborate

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jennifer L Robinson, Ph.D.

CONTACT

3345212177; jointhealthstudy@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Blinding information will be held by the study sponsor, VDF FutureCeuticals, Inc. The study will be conducted in a double-blind fashion such that both the investigators and the participants are unaware of their assignment. Unblinding will only occur once the study has been completed.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomly assigned to one of two groups - calcium fructoborate (CFB) or placebo.

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 30, 2022
• Study Start: July 1, 2022
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: August 16, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)