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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
18
partially hydrolyzed Collagen and its associated proteins including Bone Morphogenetic Proteins (BMPs)
Maltodextrin
Center for Nutraceutical and Dietary Supplement Reseach
Memphis, Tennessee, United States
TNF-alpha
TNF-alpha measured in blood
Time frame: baseline of day 1
TNF-alpha
TNF-alpha measured in blood
Time frame: baseline of day 15
TNF-alpha
TNF-alpha measured in blood
Time frame: 60 min after treatment ingestion of day 1
TNF-alpha
TNF-alpha measured in blood
Time frame: 60 min after treatment ingestion of day 15
TNF-alpha
TNF-alpha measured in blood
Time frame: 120 min after treatment ingestion of day 1
TNF-alpha
TNF-alpha measured in blood
Time frame: 120 min after treatment ingestion of day 15
IL-6
IL-6 measured in blood
Time frame: baseline of day 1
IL-6
IL-6 measured in blood
Time frame: baseline of day 15
IL-6
IL-6 measured in blood
Time frame: 60 min after treatment ingestion of day 1
IL-6
IL-6 measured in blood
Time frame: 60 min after treatment ingestion of day 15
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IL-6
IL-6 measured in blood
Time frame: 120 min after treatment ingestion of day 1
IL-6
IL-6 measured in blood
Time frame: 120 min after treatment ingestion of day 15
IL-10
IL-10 measured in blood
Time frame: baseline of day 1
IL-10
IL-10 measured in blood
Time frame: baseline of day 15
IL-10
IL-10 measured in blood
Time frame: 60 min after treatment ingestion of day 1
IL-10
IL-10 measured in blood
Time frame: 60 min after treatment ingestion of day 15
IL-10
IL-10 measured in blood
Time frame: 120 min after treatment ingestion of day 1
IL-10
IL-10 measured in blood
Time frame: 120 min after treatment ingestion of day 15
IL-1beta
IL-1beta measured in blood
Time frame: baseline of day 1
IL-1beta
IL-1beta measured in blood
Time frame: baseline of day 15
IL-1beta
IL-1beta measured in blood
Time frame: 60 min after treatment ingestion of day 1
IL-1beta
IL-1beta measured in blood
Time frame: 60 min after treatment ingestion of day 15
IL-1beta
IL-1beta measured in blood
Time frame: 120 min after treatment ingestion of day 1
IL-1beta
IL-1beta measured in blood
Time frame: 120 min after treatment ingestion of day 15
osteocalcin
osteocalcin measured in blood
Time frame: baseline day 1
osteocalcin
osteocalcin measured in blood
Time frame: baseline day 15
osteocalcin
osteocalcin measured in blood
Time frame: 60 min after treatment ingestion of day 1
osteocalcin
osteocalcin measured in blood
Time frame: 60 min after treatment ingestion of day 15
osteocalcin
osteocalcin measured in blood
Time frame: 120 min after treatment ingestion of day 1
osteocalcin
osteocalcin measured in blood
Time frame: 120 min after treatment ingestion of day 15
alkaline phosphatase
alkaline phosphatase measured in blood
Time frame: baseline day 1
alkaline phosphatase
alkaline phosphatase measured in blood
Time frame: baseline day 15
alkaline phosphatase
alkaline phosphatase measured in blood
Time frame: 60 min after treatment ingestion of day 1
alkaline phosphatase
alkaline phosphatase measured in blood
Time frame: 60 min after treatment ingestion of day 15
alkaline phosphatase
alkaline phosphatase measured in blood
Time frame: 120 min after treatment ingestion of day 1
alkaline phosphatase
alkaline phosphatase measured in blood
Time frame: 120 min after treatment ingestion of day 15
Bone Morphogenetic Protein
Bone Morphogenetic Protein measured in blood
Time frame: baseline day 1
Bone Morphogenetic Protein
Bone Morphogenetic Protein measured in blood
Time frame: baseline day 15
Bone Morphogenetic Protein
Bone Morphogenetic Protein measured in blood
Time frame: 60 min after treatment ingestion of day 1
Bone Morphogenetic Protein
Bone Morphogenetic Protein measured in blood
Time frame: 60 min after treatment ingestion of day 15
Bone Morphogenetic Protein
Bone Morphogenetic Protein measured in blood
Time frame: 120 min after treatment ingestion of day 1
Bone Morphogenetic Protein
Bone Morphogenetic Protein measured in blood
Time frame: 120 min after treatment ingestion of day 15
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).
Time frame: Day 1 of treatment
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).
Time frame: Day 15 of treatment
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.
Time frame: Day 1 of treatment
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.
Time frame: Day 15 of treatment
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
Time frame: Day 1 of treatment
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
Time frame: Day 15 of treatment