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

August 19, 2022 updated by: Richard Bloomer, University of Memphis

Short-term Impact of Cyplexinol® on Inflammatory Status and Related Measures in Men and Women With Self-reported Joint Pain

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Memphis, Tennessee, United States, 38152
        • Center for Nutraceutical and Dietary Supplement Reseach

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
TNF-alpha
Time Frame: baseline of day 1
TNF-alpha measured in blood
baseline of day 1
TNF-alpha
Time Frame: baseline of day 15
TNF-alpha measured in blood
baseline of day 15
TNF-alpha
Time Frame: 60 min after treatment ingestion of day 1
TNF-alpha measured in blood
60 min after treatment ingestion of day 1
TNF-alpha
Time Frame: 60 min after treatment ingestion of day 15
TNF-alpha measured in blood
60 min after treatment ingestion of day 15
TNF-alpha
Time Frame: 120 min after treatment ingestion of day 1
TNF-alpha measured in blood
120 min after treatment ingestion of day 1
TNF-alpha
Time Frame: 120 min after treatment ingestion of day 15
TNF-alpha measured in blood
120 min after treatment ingestion of day 15
IL-6
Time Frame: baseline of day 1
IL-6 measured in blood
baseline of day 1
IL-6
Time Frame: baseline of day 15
IL-6 measured in blood
baseline of day 15
IL-6
Time Frame: 60 min after treatment ingestion of day 1
IL-6 measured in blood
60 min after treatment ingestion of day 1
IL-6
Time Frame: 60 min after treatment ingestion of day 15
IL-6 measured in blood
60 min after treatment ingestion of day 15
IL-6
Time Frame: 120 min after treatment ingestion of day 1
IL-6 measured in blood
120 min after treatment ingestion of day 1
IL-6
Time Frame: 120 min after treatment ingestion of day 15
IL-6 measured in blood
120 min after treatment ingestion of day 15
IL-10
Time Frame: baseline of day 1
IL-10 measured in blood
baseline of day 1
IL-10
Time Frame: baseline of day 15
IL-10 measured in blood
baseline of day 15
IL-10
Time Frame: 60 min after treatment ingestion of day 1
IL-10 measured in blood
60 min after treatment ingestion of day 1
IL-10
Time Frame: 60 min after treatment ingestion of day 15
IL-10 measured in blood
60 min after treatment ingestion of day 15
IL-10
Time Frame: 120 min after treatment ingestion of day 1
IL-10 measured in blood
120 min after treatment ingestion of day 1
IL-10
Time Frame: 120 min after treatment ingestion of day 15
IL-10 measured in blood
120 min after treatment ingestion of day 15
IL-1beta
Time Frame: baseline of day 1
IL-1beta measured in blood
baseline of day 1
IL-1beta
Time Frame: baseline of day 15
IL-1beta measured in blood
baseline of day 15
IL-1beta
Time Frame: 60 min after treatment ingestion of day 1
IL-1beta measured in blood
60 min after treatment ingestion of day 1
IL-1beta
Time Frame: 60 min after treatment ingestion of day 15
IL-1beta measured in blood
60 min after treatment ingestion of day 15
IL-1beta
Time Frame: 120 min after treatment ingestion of day 1
IL-1beta measured in blood
120 min after treatment ingestion of day 1
IL-1beta
Time Frame: 120 min after treatment ingestion of day 15
IL-1beta measured in blood
120 min after treatment ingestion of day 15
osteocalcin
Time Frame: baseline day 1
osteocalcin measured in blood
baseline day 1
osteocalcin
Time Frame: baseline day 15
osteocalcin measured in blood
baseline day 15
osteocalcin
Time Frame: 60 min after treatment ingestion of day 1
osteocalcin measured in blood
60 min after treatment ingestion of day 1
osteocalcin
Time Frame: 60 min after treatment ingestion of day 15
osteocalcin measured in blood
60 min after treatment ingestion of day 15
osteocalcin
Time Frame: 120 min after treatment ingestion of day 1
osteocalcin measured in blood
120 min after treatment ingestion of day 1
osteocalcin
Time Frame: 120 min after treatment ingestion of day 15
osteocalcin measured in blood
120 min after treatment ingestion of day 15
alkaline phosphatase
Time Frame: baseline day 1
alkaline phosphatase measured in blood
baseline day 1
alkaline phosphatase
Time Frame: baseline day 15
alkaline phosphatase measured in blood
baseline day 15
alkaline phosphatase
Time Frame: 60 min after treatment ingestion of day 1
alkaline phosphatase measured in blood
60 min after treatment ingestion of day 1
alkaline phosphatase
Time Frame: 60 min after treatment ingestion of day 15
alkaline phosphatase measured in blood
60 min after treatment ingestion of day 15
alkaline phosphatase
Time Frame: 120 min after treatment ingestion of day 1
alkaline phosphatase measured in blood
120 min after treatment ingestion of day 1
alkaline phosphatase
Time Frame: 120 min after treatment ingestion of day 15
alkaline phosphatase measured in blood
120 min after treatment ingestion of day 15
Bone Morphogenetic Protein
Time Frame: baseline day 1
Bone Morphogenetic Protein measured in blood
baseline day 1
Bone Morphogenetic Protein
Time Frame: baseline day 15
Bone Morphogenetic Protein measured in blood
baseline day 15
Bone Morphogenetic Protein
Time Frame: 60 min after treatment ingestion of day 1
Bone Morphogenetic Protein measured in blood
60 min after treatment ingestion of day 1
Bone Morphogenetic Protein
Time Frame: 60 min after treatment ingestion of day 15
Bone Morphogenetic Protein measured in blood
60 min after treatment ingestion of day 15
Bone Morphogenetic Protein
Time Frame: 120 min after treatment ingestion of day 1
Bone Morphogenetic Protein measured in blood
120 min after treatment ingestion of day 1
Bone Morphogenetic Protein
Time Frame: 120 min after treatment ingestion of day 15
Bone Morphogenetic Protein measured in blood
120 min after treatment ingestion of day 15
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).
Day 1 of treatment
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).
Day 15 of treatment
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.
Day 1 of treatment
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.
Day 15 of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Day 1 of treatment
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
Day 15 of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Memphis

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
ZyCal Bioceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 17, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 28, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 28, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 18, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 22, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRO-FY2021-6

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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