Clinical trial NCT04764110: Short-term Impact of Cyplexinol® on Self-reported Joint Pain
Official title: Short-term Impact of Cyplexinol® on Inflammatory Status and Related Measures in Men and Women With Self-reported Joint Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Joint Pain
Keywords: Cyplexinol
Inflammation
Lead sponsor: University of Memphis
Sponsor class: OTHER
Collaborators: name: ZyCal Bioceuticals
First posted: 2021-02-21
Enrollment: 18
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Double-blind, randomized, control
Primary purpose: BASIC_SCIENCE

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.

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)

Primary outcomes:
measure: TNF-alpha
timeFrame: baseline of day 1
measure: TNF-alpha
timeFrame: baseline of day 15
measure: TNF-alpha
timeFrame: 60 min after treatment ingestion of day 1
measure: TNF-alpha
timeFrame: 60 min after treatment ingestion of day 15
measure: TNF-alpha
timeFrame: 120 min after treatment ingestion of day 1
measure: TNF-alpha
timeFrame: 120 min after treatment ingestion of day 15
measure: IL-6
timeFrame: baseline of day 1
measure: IL-6
timeFrame: baseline of day 15
measure: IL-6
timeFrame: 60 min after treatment ingestion of day 1
measure: IL-6
timeFrame: 60 min after treatment ingestion of day 15
measure: IL-6
timeFrame: 120 min after treatment ingestion of day 1
measure: IL-6
timeFrame: 120 min after treatment ingestion of day 15
measure: IL-10
timeFrame: baseline of day 1
measure: IL-10
timeFrame: baseline of day 15
measure: IL-10
timeFrame: 60 min after treatment ingestion of day 1
measure: IL-10
timeFrame: 60 min after treatment ingestion of day 15
measure: IL-10
timeFrame: 120 min after treatment ingestion of day 1
measure: IL-10
timeFrame: 120 min after treatment ingestion of day 15
measure: IL-1beta
timeFrame: baseline of day 1
measure: IL-1beta
timeFrame: baseline of day 15
measure: IL-1beta
timeFrame: 60 min after treatment ingestion of day 1
measure: IL-1beta
timeFrame: 60 min after treatment ingestion of day 15
measure: IL-1beta
timeFrame: 120 min after treatment ingestion of day 1
measure: IL-1beta
timeFrame: 120 min after treatment ingestion of day 15
measure: osteocalcin
timeFrame: baseline day 1
measure: osteocalcin
timeFrame: baseline day 15
measure: osteocalcin
timeFrame: 60 min after treatment ingestion of day 1
measure: osteocalcin
timeFrame: 60 min after treatment ingestion of day 15
measure: osteocalcin
timeFrame: 120 min after treatment ingestion of day 1
measure: osteocalcin
timeFrame: 120 min after treatment ingestion of day 15
measure: alkaline phosphatase
timeFrame: baseline day 1
measure: alkaline phosphatase
timeFrame: baseline day 15
measure: alkaline phosphatase
timeFrame: 60 min after treatment ingestion of day 1
measure: alkaline phosphatase
timeFrame: 60 min after treatment ingestion of day 15
measure: alkaline phosphatase
timeFrame: 120 min after treatment ingestion of day 1
measure: alkaline phosphatase
timeFrame: 120 min after treatment ingestion of day 15
measure: Bone Morphogenetic Protein
timeFrame: baseline day 1
measure: Bone Morphogenetic Protein
timeFrame: baseline day 15
measure: Bone Morphogenetic Protein
timeFrame: 60 min after treatment ingestion of day 1
measure: Bone Morphogenetic Protein
timeFrame: 60 min after treatment ingestion of day 15
measure: Bone Morphogenetic Protein
timeFrame: 120 min after treatment ingestion of day 1
measure: Bone Morphogenetic Protein
timeFrame: 120 min after treatment ingestion of day 15
measure: Joint pain visual analog scale
timeFrame: Day 1 of treatment
measure: Joint pain visual analog scale
timeFrame: Day 15 of treatment
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: Day 1 of treatment
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: Day 15 of treatment
Secondary outcomes:
measure: Dietary intake
timeFrame: Day 1 of treatment
measure: Dietary intake
timeFrame: Day 15 of treatment
Other outcomes:
Locations:
city: Memphis
country: United States
facility: Center for Nutraceutical and Dietary Supplement Reseach
state: Tennessee
Study officials:
affiliation: University of Memphis
name: Richard Bloomer, PhD
role: PRINCIPAL_INVESTIGATOR
References: