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

Joint Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04764110
• Other study ID #: PRO-FY2021-6
• Status: Completed
• Phase: N/A
• Start date: March 17, 2021
• Est. completion date: January 28, 2022

Study information

• Verified date: August 2022
• Source: University of Memphis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 28, 2022
• Est. primary completion date: January 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Arthralgia
• Joint Pain

Intervention

Dietary Supplement:
• Cyplexinol
partially hydrolyzed Collagen and its associated proteins including Bone Morphogenetic Proteins (BMPs)

Other:
• Placebo
Maltodextrin

Locations

Country	Name	City	State
United States	Center for Nutraceutical and Dietary Supplement Reseach	Memphis	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
University of Memphis	ZyCal Bioceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TNF-alpha	TNF-alpha measured in blood	baseline of day 1
Primary	TNF-alpha	TNF-alpha measured in blood	baseline of day 15
Primary	TNF-alpha	TNF-alpha measured in blood	60 min after treatment ingestion of day 1
Primary	TNF-alpha	TNF-alpha measured in blood	60 min after treatment ingestion of day 15
Primary	TNF-alpha	TNF-alpha measured in blood	120 min after treatment ingestion of day 1
Primary	TNF-alpha	TNF-alpha measured in blood	120 min after treatment ingestion of day 15
Primary	IL-6	IL-6 measured in blood	baseline of day 1
Primary	IL-6	IL-6 measured in blood	baseline of day 15
Primary	IL-6	IL-6 measured in blood	60 min after treatment ingestion of day 1
Primary	IL-6	IL-6 measured in blood	60 min after treatment ingestion of day 15
Primary	IL-6	IL-6 measured in blood	120 min after treatment ingestion of day 1
Primary	IL-6	IL-6 measured in blood	120 min after treatment ingestion of day 15
Primary	IL-10	IL-10 measured in blood	baseline of day 1
Primary	IL-10	IL-10 measured in blood	baseline of day 15
Primary	IL-10	IL-10 measured in blood	60 min after treatment ingestion of day 1
Primary	IL-10	IL-10 measured in blood	60 min after treatment ingestion of day 15
Primary	IL-10	IL-10 measured in blood	120 min after treatment ingestion of day 1
Primary	IL-10	IL-10 measured in blood	120 min after treatment ingestion of day 15
Primary	IL-1beta	IL-1beta measured in blood	baseline of day 1
Primary	IL-1beta	IL-1beta measured in blood	baseline of day 15
Primary	IL-1beta	IL-1beta measured in blood	60 min after treatment ingestion of day 1
Primary	IL-1beta	IL-1beta measured in blood	60 min after treatment ingestion of day 15
Primary	IL-1beta	IL-1beta measured in blood	120 min after treatment ingestion of day 1
Primary	IL-1beta	IL-1beta measured in blood	120 min after treatment ingestion of day 15
Primary	osteocalcin	osteocalcin measured in blood	baseline day 1
Primary	osteocalcin	osteocalcin measured in blood	baseline day 15
Primary	osteocalcin	osteocalcin measured in blood	60 min after treatment ingestion of day 1
Primary	osteocalcin	osteocalcin measured in blood	60 min after treatment ingestion of day 15
Primary	osteocalcin	osteocalcin measured in blood	120 min after treatment ingestion of day 1
Primary	osteocalcin	osteocalcin measured in blood	120 min after treatment ingestion of day 15
Primary	alkaline phosphatase	alkaline phosphatase measured in blood	baseline day 1
Primary	alkaline phosphatase	alkaline phosphatase measured in blood	baseline day 15
Primary	alkaline phosphatase	alkaline phosphatase measured in blood	60 min after treatment ingestion of day 1
Primary	alkaline phosphatase	alkaline phosphatase measured in blood	60 min after treatment ingestion of day 15
Primary	alkaline phosphatase	alkaline phosphatase measured in blood	120 min after treatment ingestion of day 1
Primary	alkaline phosphatase	alkaline phosphatase measured in blood	120 min after treatment ingestion of day 15
Primary	Bone Morphogenetic Protein	Bone Morphogenetic Protein measured in blood	baseline day 1
Primary	Bone Morphogenetic Protein	Bone Morphogenetic Protein measured in blood	baseline day 15
Primary	Bone Morphogenetic Protein	Bone Morphogenetic Protein measured in blood	60 min after treatment ingestion of day 1
Primary	Bone Morphogenetic Protein	Bone Morphogenetic Protein measured in blood	60 min after treatment ingestion of day 15
Primary	Bone Morphogenetic Protein	Bone Morphogenetic Protein measured in blood	120 min after treatment ingestion of day 1
Primary	Bone Morphogenetic Protein	Bone Morphogenetic Protein measured in blood	120 min after treatment ingestion of day 15
Primary	Joint pain visual analog scale	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
Primary	Joint pain visual analog scale	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
Primary	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	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
Primary	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	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	Dietary intake	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
Secondary	Dietary intake	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