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

NCT ID: NCT04764110

Last Updated: 2022-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-17
• Study Completion Date: 2022-01-28

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.

Conditions

Joint Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Cyplexinol

900 mg daily (2 capsules) for 15 days

Group Type: EXPERIMENTAL

Cyplexinol

Intervention Type: DIETARY_SUPPLEMENT

partially hydrolyzed Collagen and its associated proteins including Bone Morphogenetic Proteins (BMPs)

Placebo

2 capsules daily for 15 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Maltodextrin

Interventions

Cyplexinol

partially hydrolyzed Collagen and its associated proteins including Bone Morphogenetic Proteins (BMPs)

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Maltodextrin

Intervention Type: OTHER

Eligibility 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)

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ZyCal Bioceuticals

UNKNOWN

Sponsor Role: collaborator

University of Memphis

OTHER

Sponsor Role: lead

Responsible Party

Richard Bloomer

Dean of the College of Health Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard Bloomer, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Memphis

Locations

Center for Nutraceutical and Dietary Supplement Reseach

Memphis, Tennessee, United States

Countries

United States

Other Identifiers

PRO-FY2021-6

Identifier Type: -

Identifier Source: org_study_id