Short-term Impact of Cyplexinol® on Inflammatory Status and Related Measures in Men and Women With Self-reported Joint Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
Double-blind
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Cyplexinol
900 mg daily (2 capsules) for 15 days
干预措施: Cyplexinol (Dietary Supplement)
Placebo
2 capsules daily for 15 days
干预措施: Placebo (Other)
结局指标
主要结局
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
时间窗: 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.
TNF-alpha
时间窗: 120 min after treatment ingestion of day 15
TNF-alpha measured in blood
IL-10
时间窗: 120 min after treatment ingestion of day 15
IL-10 measured in blood
IL-6
时间窗: 120 min after treatment ingestion of day 15
IL-6 measured in blood
IL-1beta
时间窗: 120 min after treatment ingestion of day 15
IL-1beta measured in blood
osteocalcin
时间窗: 120 min after treatment ingestion of day 15
osteocalcin measured in blood
alkaline phosphatase
时间窗: 120 min after treatment ingestion of day 15
alkaline phosphatase measured in blood
Bone Morphogenetic Protein
时间窗: 120 min after treatment ingestion of day 15
Bone Morphogenetic Protein measured in blood
Joint pain visual analog scale
时间窗: 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).
osteocalcin
时间窗: baseline day 1
osteocalcin measured in blood
osteocalcin
时间窗: baseline day 15
osteocalcin measured in blood
TNF-alpha
时间窗: baseline of day 1
TNF-alpha measured in blood
TNF-alpha
时间窗: baseline of day 15
TNF-alpha measured in blood
TNF-alpha
时间窗: 60 min after treatment ingestion of day 1
TNF-alpha measured in blood
TNF-alpha
时间窗: 60 min after treatment ingestion of day 15
TNF-alpha measured in blood
TNF-alpha
时间窗: 120 min after treatment ingestion of day 1
TNF-alpha measured in blood
IL-6
时间窗: baseline of day 1
IL-6 measured in blood
IL-6
时间窗: baseline of day 15
IL-6 measured in blood
IL-6
时间窗: 60 min after treatment ingestion of day 1
IL-6 measured in blood
IL-6
时间窗: 60 min after treatment ingestion of day 15
IL-6 measured in blood
IL-6
时间窗: 120 min after treatment ingestion of day 1
IL-6 measured in blood
IL-10
时间窗: baseline of day 1
IL-10 measured in blood
IL-10
时间窗: baseline of day 15
IL-10 measured in blood
IL-10
时间窗: 60 min after treatment ingestion of day 1
IL-10 measured in blood
IL-10
时间窗: 60 min after treatment ingestion of day 15
IL-10 measured in blood
IL-10
时间窗: 120 min after treatment ingestion of day 1
IL-10 measured in blood
IL-1beta
时间窗: baseline of day 1
IL-1beta measured in blood
IL-1beta
时间窗: baseline of day 15
IL-1beta measured in blood
IL-1beta
时间窗: 60 min after treatment ingestion of day 1
IL-1beta measured in blood
IL-1beta
时间窗: 60 min after treatment ingestion of day 15
IL-1beta measured in blood
IL-1beta
时间窗: 120 min after treatment ingestion of day 1
IL-1beta measured in blood
osteocalcin
时间窗: 60 min after treatment ingestion of day 1
osteocalcin measured in blood
osteocalcin
时间窗: 60 min after treatment ingestion of day 15
osteocalcin measured in blood
osteocalcin
时间窗: 120 min after treatment ingestion of day 1
osteocalcin measured in blood
alkaline phosphatase
时间窗: baseline day 1
alkaline phosphatase measured in blood
alkaline phosphatase
时间窗: baseline day 15
alkaline phosphatase measured in blood
alkaline phosphatase
时间窗: 60 min after treatment ingestion of day 1
alkaline phosphatase measured in blood
alkaline phosphatase
时间窗: 60 min after treatment ingestion of day 15
alkaline phosphatase measured in blood
alkaline phosphatase
时间窗: 120 min after treatment ingestion of day 1
alkaline phosphatase measured in blood
Bone Morphogenetic Protein
时间窗: baseline day 1
Bone Morphogenetic Protein measured in blood
Bone Morphogenetic Protein
时间窗: baseline day 15
Bone Morphogenetic Protein measured in blood
Bone Morphogenetic Protein
时间窗: 60 min after treatment ingestion of day 1
Bone Morphogenetic Protein measured in blood
Bone Morphogenetic Protein
时间窗: 60 min after treatment ingestion of day 15
Bone Morphogenetic Protein measured in blood
Bone Morphogenetic Protein
时间窗: 120 min after treatment ingestion of day 1
Bone Morphogenetic Protein measured in blood
Joint pain visual analog scale
时间窗: 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).
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
时间窗: 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.
次要结局
- Dietary intake(Day 15 of treatment)
- Dietary intake(Day 1 of treatment)
研究者
Richard Bloomer
Dean of the College of Health Sciences
University of Memphis