Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE February 18, 2021
First Posted Date  ICMJE February 21, 2021
Last Update Posted Date April 28, 2021
Actual Study Start Date  ICMJE March 17, 2021
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 18, 2021)
  • TNF-alpha [ Time Frame: baseline of day 1 ]
    TNF-alpha measured in blood
  • TNF-alpha [ Time Frame: baseline of day 15 ]
    TNF-alpha measured in blood
  • TNF-alpha [ Time Frame: 60 min after treatment ingestion of day 1 ]
    TNF-alpha measured in blood
  • TNF-alpha [ Time Frame: 60 min after treatment ingestion of day 15 ]
    TNF-alpha measured in blood
  • TNF-alpha [ Time Frame: 120 min after treatment ingestion of day 1 ]
    TNF-alpha measured in blood
  • TNF-alpha [ Time Frame: 120 min after treatment ingestion of day 15 ]
    TNF-alpha measured in blood
  • IL-6 [ Time Frame: baseline of day 1 ]
    IL-6 measured in blood
  • IL-6 [ Time Frame: baseline of day 15 ]
    IL-6 measured in blood
  • IL-6 [ Time Frame: 60 min after treatment ingestion of day 1 ]
    IL-6 measured in blood
  • IL-6 [ Time Frame: 60 min after treatment ingestion of day 15 ]
    IL-6 measured in blood
  • IL-6 [ Time Frame: 120 min after treatment ingestion of day 1 ]
    IL-6 measured in blood
  • IL-6 [ Time Frame: 120 min after treatment ingestion of day 15 ]
    IL-6 measured in blood
  • IL-10 [ Time Frame: baseline of day 1 ]
    IL-10 measured in blood
  • IL-10 [ Time Frame: baseline of day 15 ]
    IL-10 measured in blood
  • IL-10 [ Time Frame: 60 min after treatment ingestion of day 1 ]
    IL-10 measured in blood
  • IL-10 [ Time Frame: 60 min after treatment ingestion of day 15 ]
    IL-10 measured in blood
  • IL-10 [ Time Frame: 120 min after treatment ingestion of day 1 ]
    IL-10 measured in blood
  • IL-10 [ Time Frame: 120 min after treatment ingestion of day 15 ]
    IL-10 measured in blood
  • IL-1beta [ Time Frame: baseline of day 1 ]
    IL-1beta measured in blood
  • IL-1beta [ Time Frame: baseline of day 15 ]
    IL-1beta measured in blood
  • IL-1beta [ Time Frame: 60 min after treatment ingestion of day 1 ]
    IL-1beta measured in blood
  • IL-1beta [ Time Frame: 60 min after treatment ingestion of day 15 ]
    IL-1beta measured in blood
  • IL-1beta [ Time Frame: 120 min after treatment ingestion of day 1 ]
    IL-1beta measured in blood
  • IL-1beta [ Time Frame: 120 min after treatment ingestion of day 15 ]
    IL-1beta measured in blood
  • osteocalcin [ Time Frame: baseline day 1 ]
    osteocalcin measured in blood
  • osteocalcin [ Time Frame: baseline day 15 ]
    osteocalcin measured in blood
  • osteocalcin [ Time Frame: 60 min after treatment ingestion of day 1 ]
    osteocalcin measured in blood
  • osteocalcin [ Time Frame: 60 min after treatment ingestion of day 15 ]
    osteocalcin measured in blood
  • osteocalcin [ Time Frame: 120 min after treatment ingestion of day 1 ]
    osteocalcin measured in blood
  • osteocalcin [ Time Frame: 120 min after treatment ingestion of day 15 ]
    osteocalcin measured in blood
  • alkaline phosphatase [ Time Frame: baseline day 1 ]
    alkaline phosphatase measured in blood
  • alkaline phosphatase [ Time Frame: baseline day 15 ]
    alkaline phosphatase measured in blood
  • alkaline phosphatase [ Time Frame: 60 min after treatment ingestion of day 1 ]
    alkaline phosphatase measured in blood
  • alkaline phosphatase [ Time Frame: 60 min after treatment ingestion of day 15 ]
    alkaline phosphatase measured in blood
  • alkaline phosphatase [ Time Frame: 120 min after treatment ingestion of day 1 ]
    alkaline phosphatase measured in blood
  • alkaline phosphatase [ Time Frame: 120 min after treatment ingestion of day 15 ]
    alkaline phosphatase measured in blood
  • Bone Morphogenetic Protein [ Time Frame: baseline day 1 ]
    Bone Morphogenetic Protein measured in blood
  • Bone Morphogenetic Protein [ Time Frame: baseline day 15 ]
    Bone Morphogenetic Protein measured in blood
  • Bone Morphogenetic Protein [ Time Frame: 60 min after treatment ingestion of day 1 ]
    Bone Morphogenetic Protein measured in blood
  • Bone Morphogenetic Protein [ Time Frame: 60 min after treatment ingestion of day 15 ]
    Bone Morphogenetic Protein measured in blood
  • Bone Morphogenetic Protein [ Time Frame: 120 min after treatment ingestion of day 1 ]
    Bone Morphogenetic Protein measured in blood
  • Bone Morphogenetic Protein [ Time Frame: 120 min after treatment ingestion of day 15 ]
    Bone Morphogenetic Protein measured in blood
  • 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).
  • 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).
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2021)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Short-term Impact of Cyplexinol® on Self-reported Joint Pain
Official Title  ICMJE Short-term Impact of Cyplexinol® on Inflammatory Status and Related Measures in Men and Women With Self-reported Joint Pain
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Joint Pain
Intervention  ICMJE
  • Dietary Supplement: Cyplexinol
    partially hydrolyzed Collagen and its associated proteins including Bone Morphogenetic Proteins (BMPs)
  • Other: Placebo
    Maltodextrin
Study Arms  ICMJE
  • Experimental: Cyplexinol
    900 mg daily (2 capsules) for 15 days
    Intervention: Dietary Supplement: Cyplexinol
  • Placebo Comparator: Placebo
    2 capsules daily for 15 days
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 18, 2021)
18
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2021
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jacquelyn Pence, PhD 901-678-1547 jpence1@memphis.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04764110
Other Study ID Numbers  ICMJE PRO-FY2021-6
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Richard Bloomer, University of Memphis
Study Sponsor  ICMJE University of Memphis
Collaborators  ICMJE ZyCal Bioceuticals
Investigators  ICMJE
Principal Investigator: Richard Bloomer, PhD University of Memphis
PRS Account University of Memphis
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP