Short-term Impact of Cyplexinol® on Self-reported Joint Pain
1 other identifier
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2021
CompletedFirst Posted
Study publicly available on registry
February 21, 2021
CompletedStudy Start
First participant enrolled
March 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 28, 2022
CompletedAugust 22, 2022
August 1, 2022
11 months
February 18, 2021
August 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (46)
TNF-alpha
TNF-alpha measured in blood
baseline of day 1
TNF-alpha
TNF-alpha measured in blood
baseline of day 15
TNF-alpha
TNF-alpha measured in blood
60 min after treatment ingestion of day 1
TNF-alpha
TNF-alpha measured in blood
60 min after treatment ingestion of day 15
TNF-alpha
TNF-alpha measured in blood
120 min after treatment ingestion of day 1
TNF-alpha
TNF-alpha measured in blood
120 min after treatment ingestion of day 15
IL-6
IL-6 measured in blood
baseline of day 1
IL-6
IL-6 measured in blood
baseline of day 15
IL-6
IL-6 measured in blood
60 min after treatment ingestion of day 1
IL-6
IL-6 measured in blood
60 min after treatment ingestion of day 15
IL-6
IL-6 measured in blood
120 min after treatment ingestion of day 1
IL-6
IL-6 measured in blood
120 min after treatment ingestion of day 15
IL-10
IL-10 measured in blood
baseline of day 1
IL-10
IL-10 measured in blood
baseline of day 15
IL-10
IL-10 measured in blood
60 min after treatment ingestion of day 1
IL-10
IL-10 measured in blood
60 min after treatment ingestion of day 15
IL-10
IL-10 measured in blood
120 min after treatment ingestion of day 1
IL-10
IL-10 measured in blood
120 min after treatment ingestion of day 15
IL-1beta
IL-1beta measured in blood
baseline of day 1
IL-1beta
IL-1beta measured in blood
baseline of day 15
IL-1beta
IL-1beta measured in blood
60 min after treatment ingestion of day 1
IL-1beta
IL-1beta measured in blood
60 min after treatment ingestion of day 15
IL-1beta
IL-1beta measured in blood
120 min after treatment ingestion of day 1
IL-1beta
IL-1beta measured in blood
120 min after treatment ingestion of day 15
osteocalcin
osteocalcin measured in blood
baseline day 1
osteocalcin
osteocalcin measured in blood
baseline day 15
osteocalcin
osteocalcin measured in blood
60 min after treatment ingestion of day 1
osteocalcin
osteocalcin measured in blood
60 min after treatment ingestion of day 15
osteocalcin
osteocalcin measured in blood
120 min after treatment ingestion of day 1
osteocalcin
osteocalcin measured in blood
120 min after treatment ingestion of day 15
alkaline phosphatase
alkaline phosphatase measured in blood
baseline day 1
alkaline phosphatase
alkaline phosphatase measured in blood
baseline day 15
alkaline phosphatase
alkaline phosphatase measured in blood
60 min after treatment ingestion of day 1
alkaline phosphatase
alkaline phosphatase measured in blood
60 min after treatment ingestion of day 15
alkaline phosphatase
alkaline phosphatase measured in blood
120 min after treatment ingestion of day 1
alkaline phosphatase
alkaline phosphatase measured in blood
120 min after treatment ingestion of day 15
Bone Morphogenetic Protein
Bone Morphogenetic Protein measured in blood
baseline day 1
Bone Morphogenetic Protein
Bone Morphogenetic Protein measured in blood
baseline day 15
Bone Morphogenetic Protein
Bone Morphogenetic Protein measured in blood
60 min after treatment ingestion of day 1
Bone Morphogenetic Protein
Bone Morphogenetic Protein measured in blood
60 min after treatment ingestion of day 15
Bone Morphogenetic Protein
Bone Morphogenetic Protein measured in blood
120 min after treatment ingestion of day 1
Bone Morphogenetic Protein
Bone Morphogenetic Protein measured in blood
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).
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).
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.
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.
Day 15 of treatment
Secondary Outcomes (2)
Dietary intake
Day 1 of treatment
Dietary intake
Day 15 of treatment
Study Arms (2)
Cyplexinol
EXPERIMENTAL900 mg daily (2 capsules) for 15 days
Placebo
PLACEBO COMPARATOR2 capsules daily for 15 days
Interventions
partially hydrolyzed Collagen and its associated proteins including Bone Morphogenetic Proteins (BMPs)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Memphislead
- ZyCal Bioceuticalscollaborator
Study Sites (1)
Center for Nutraceutical and Dietary Supplement Reseach
Memphis, Tennessee, 38152, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Bloomer, PhD
University of Memphis
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Double-blind
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dean of the College of Health Sciences
Study Record Dates
First Submitted
February 18, 2021
First Posted
February 21, 2021
Study Start
March 17, 2021
Primary Completion
January 28, 2022
Study Completion
January 28, 2022
Last Updated
August 22, 2022
Record last verified: 2022-08