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Short-term Impact of Cyplexinol® on Self-reported Joint Pain

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ClinicalTrials.gov Identifier: NCT04764110
Recruitment Status : Recruiting
First Posted : February 21, 2021
Last Update Posted : April 28, 2021
Sponsor:
Collaborator:
ZyCal Bioceuticals
Information provided by (Responsible Party):
Richard Bloomer, University of Memphis

Brief Summary:
In this study, the impact of 900 mg Cyplexinol® taken daily on joint pain over a period of 15 days in comparison with a placebo will be determined using a cross-over double blind design with a 13 day wash out period. In addition, we will measure cytokine production and related variables during the two hour after subjects ingest a single dosage of Cyplexinol® or placebo on days 1 and 15.

Condition or disease Intervention/treatment Phase
Joint Pain Dietary Supplement: Cyplexinol Other: Placebo Not Applicable

Detailed Description:

Chronic inflammation can induce joint pain, which is a common problem among adult men and women. ZyCal Bioceuticals is a manufacturer of natural ingredients and finished nutritional supplements to support bone and joint health in humans. The core ingredient in all ZyCal products is Cyplexinol® (a Bone Morphogenetic Protein [BMP] Complex). BMP complexes have been shown to activate mesenchymal stem cells to help the body regenerate osteoblasts and chondrocytes. BMPs were initially identified in the 1970's as osteogenic factors which stimulate activation, proliferation, and differentiation of osteoprogenitor cells by binding BMP receptors and subsequent signaling through the SMAD pathway. BMPs have also been shown to reduce inflammation and promote healthy inflammatory signaling in joints and other tissues.

Cyplexinol® is delivered in the dietary supplement called Ostinol™, which has been safely used in oral form by thousands of people since 2007 for bone and joint health. Currently Cyplexinol® is considered a dietary supplement ingredient and has been awarded GRAS (generally recognized as safe).

Studies have been conducted to evaluate the safety and efficacy of Cyplexinol® as a dietary supplement for joint health (Garian, 2012; Scaffidi, 2017). Dosages of 150mg Cyplexinol® have been compared to a placebo (negative control) alone or in combination with glucosamine /chondroitin in randomized controlled trials for 4 -12 weeks. Endpoints examined have included joint stiffness, inflammation, pain, and overall quality of life. However, to date, no short-term studies have been conducted using Cyplexinol®, nor have any acute studies evaluated the impact of this agent on immune function.

In this study, the impact of 900 mg Cyplexinol® taken daily on joint pain over a period of 15 days in comparison with a placebo will be determined using a cross-over double blind design with a 13 day wash out period. In addition, we will measure cytokine production and related variables during the two hour post ingestion period after subjects ingest a single dosage of Cyplexinol® or placebo on days 1 and 15.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Double-blind, randomized, control
Masking: Double (Participant, Investigator)
Masking Description: Double-blind
Primary Purpose: Basic Science
Official Title: Short-term Impact of Cyplexinol® on Inflammatory Status and Related Measures in Men and Women With Self-reported Joint Pain
Actual Study Start Date : March 17, 2021
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2021

Arm Intervention/treatment
Experimental: Cyplexinol
900 mg daily (2 capsules) for 15 days
Dietary Supplement: Cyplexinol
partially hydrolyzed Collagen and its associated proteins including Bone Morphogenetic Proteins (BMPs)

Placebo Comparator: Placebo
2 capsules daily for 15 days
Other: Placebo
Maltodextrin




Primary Outcome Measures :
  1. TNF-alpha [ Time Frame: baseline of day 1 ]
    TNF-alpha measured in blood

  2. TNF-alpha [ Time Frame: baseline of day 15 ]
    TNF-alpha measured in blood

  3. TNF-alpha [ Time Frame: 60 min after treatment ingestion of day 1 ]
    TNF-alpha measured in blood

  4. TNF-alpha [ Time Frame: 60 min after treatment ingestion of day 15 ]
    TNF-alpha measured in blood

  5. TNF-alpha [ Time Frame: 120 min after treatment ingestion of day 1 ]
    TNF-alpha measured in blood

  6. TNF-alpha [ Time Frame: 120 min after treatment ingestion of day 15 ]
    TNF-alpha measured in blood

  7. IL-6 [ Time Frame: baseline of day 1 ]
    IL-6 measured in blood

  8. IL-6 [ Time Frame: baseline of day 15 ]
    IL-6 measured in blood

  9. IL-6 [ Time Frame: 60 min after treatment ingestion of day 1 ]
    IL-6 measured in blood

  10. IL-6 [ Time Frame: 60 min after treatment ingestion of day 15 ]
    IL-6 measured in blood

  11. IL-6 [ Time Frame: 120 min after treatment ingestion of day 1 ]
    IL-6 measured in blood

  12. IL-6 [ Time Frame: 120 min after treatment ingestion of day 15 ]
    IL-6 measured in blood

  13. IL-10 [ Time Frame: baseline of day 1 ]
    IL-10 measured in blood

  14. IL-10 [ Time Frame: baseline of day 15 ]
    IL-10 measured in blood

  15. IL-10 [ Time Frame: 60 min after treatment ingestion of day 1 ]
    IL-10 measured in blood

  16. IL-10 [ Time Frame: 60 min after treatment ingestion of day 15 ]
    IL-10 measured in blood

  17. IL-10 [ Time Frame: 120 min after treatment ingestion of day 1 ]
    IL-10 measured in blood

  18. IL-10 [ Time Frame: 120 min after treatment ingestion of day 15 ]
    IL-10 measured in blood

  19. IL-1beta [ Time Frame: baseline of day 1 ]
    IL-1beta measured in blood

  20. IL-1beta [ Time Frame: baseline of day 15 ]
    IL-1beta measured in blood

  21. IL-1beta [ Time Frame: 60 min after treatment ingestion of day 1 ]
    IL-1beta measured in blood

  22. IL-1beta [ Time Frame: 60 min after treatment ingestion of day 15 ]
    IL-1beta measured in blood

  23. IL-1beta [ Time Frame: 120 min after treatment ingestion of day 1 ]
    IL-1beta measured in blood

  24. IL-1beta [ Time Frame: 120 min after treatment ingestion of day 15 ]
    IL-1beta measured in blood

  25. osteocalcin [ Time Frame: baseline day 1 ]
    osteocalcin measured in blood

  26. osteocalcin [ Time Frame: baseline day 15 ]
    osteocalcin measured in blood

  27. osteocalcin [ Time Frame: 60 min after treatment ingestion of day 1 ]
    osteocalcin measured in blood

  28. osteocalcin [ Time Frame: 60 min after treatment ingestion of day 15 ]
    osteocalcin measured in blood

  29. osteocalcin [ Time Frame: 120 min after treatment ingestion of day 1 ]
    osteocalcin measured in blood

  30. osteocalcin [ Time Frame: 120 min after treatment ingestion of day 15 ]
    osteocalcin measured in blood

  31. alkaline phosphatase [ Time Frame: baseline day 1 ]
    alkaline phosphatase measured in blood

  32. alkaline phosphatase [ Time Frame: baseline day 15 ]
    alkaline phosphatase measured in blood

  33. alkaline phosphatase [ Time Frame: 60 min after treatment ingestion of day 1 ]
    alkaline phosphatase measured in blood

  34. alkaline phosphatase [ Time Frame: 60 min after treatment ingestion of day 15 ]
    alkaline phosphatase measured in blood

  35. alkaline phosphatase [ Time Frame: 120 min after treatment ingestion of day 1 ]
    alkaline phosphatase measured in blood

  36. alkaline phosphatase [ Time Frame: 120 min after treatment ingestion of day 15 ]
    alkaline phosphatase measured in blood

  37. Bone Morphogenetic Protein [ Time Frame: baseline day 1 ]
    Bone Morphogenetic Protein measured in blood

  38. Bone Morphogenetic Protein [ Time Frame: baseline day 15 ]
    Bone Morphogenetic Protein measured in blood

  39. Bone Morphogenetic Protein [ Time Frame: 60 min after treatment ingestion of day 1 ]
    Bone Morphogenetic Protein measured in blood

  40. Bone Morphogenetic Protein [ Time Frame: 60 min after treatment ingestion of day 15 ]
    Bone Morphogenetic Protein measured in blood

  41. Bone Morphogenetic Protein [ Time Frame: 120 min after treatment ingestion of day 1 ]
    Bone Morphogenetic Protein measured in blood

  42. Bone Morphogenetic Protein [ Time Frame: 120 min after treatment ingestion of day 15 ]
    Bone Morphogenetic Protein measured in blood

  43. Joint pain visual analog scale [ Time Frame: Day 1 of treatment ]
    A 100mm visual analog scale will be used to assess joint pain. Scores range from 0 (subject strongly disagreeing with prompt) to 100 (strongly agree).

  44. Joint pain visual analog scale [ Time Frame: Day 15 of treatment ]
    A 100mm visual analog scale will be used to assess joint pain. Scores range from 0 (subject strongly disagreeing with prompt) to 100 (strongly agree).

  45. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: Day 1 of treatment ]
    The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68) with 0 being none and high values being most.

  46. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: Day 15 of treatment ]
    The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68) with 0 being none and high values being most.


Secondary Outcome Measures :
  1. Dietary intake [ Time Frame: Day 1 of treatment ]
    Dietary intake of subjects for 3-days prior to testing days analyzed using Food Processor Pro software for total calories, macro- and micro-nutrient composition

  2. Dietary intake [ Time Frame: Day 15 of treatment ]
    Dietary intake of subjects for 3-days prior to testing days analyzed using Food Processor Pro software for total calories, macro- and micro-nutrient composition



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • body mass index (BMI) between 18-29.9 kg/m2 (not obese)
  • no consumption of alcohol-containing beverages within 48 hours of testing
  • experiencing self-reported joint pain with a minimum pain rating of 3/10 for at least the past 30 days
  • engaged in structured exercise 2 or more days per week for the past 6 months or longer
  • a negative verbal pre-study drug screen (alcohol abuse, amphetamines, benzodiazepines, cocaine, opioids, phencyclidine, barbiturates, cotinine), no history of use of illicit drugs or other substances of abuse within 12 months of the screening visit

Exclusion Criteria:

  • pregnant
  • tobacco user
  • active infection or illness of any kind
  • rheumatic or osteoarthritic diagnosis
  • Using anti-inflammatory medicines, pain medications, or dietary supplements (or not willing to cease for one-month prior to participation and throughout study)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04764110


Contacts
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Contact: Jacquelyn Pence, PhD 901-678-1547 jpence1@memphis.edu

Locations
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United States, Tennessee
Center for Nutraceutical and Dietary Supplement Reseach Recruiting
Memphis, Tennessee, United States, 38152
Contact: Jackie Pence, PhD    901-678-1547    jpence1@memphis.edu   
Sponsors and Collaborators
University of Memphis
ZyCal Bioceuticals
Investigators
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Principal Investigator: Richard Bloomer, PhD University of Memphis
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Responsible Party: Richard Bloomer, Dean of the College of Health Sciences, University of Memphis
ClinicalTrials.gov Identifier: NCT04764110    
Other Study ID Numbers: PRO-FY2021-6
First Posted: February 21, 2021    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Richard Bloomer, University of Memphis:
Cyplexinol
Inflammation
Additional relevant MeSH terms:
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Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations