Joint Pain, Stiffness, FunctionNCT01956500
Instaflex and Joint Pain in Community Adults
A study testing Instaflex in people with Joint Pain, Stiffness, Function, run by Appalachian State University at 1 site in United States.
Trial summary
The primary purpose of this study is to assess the effect of 8-weeks ingestion of the Instaflex Joint Support supplement (Direct Digital, Charlotte, NC) compared to placebo on joint pain, stiffness, and function (questionnaires and 6-min walk test) and blood inflammation biomarkers in adults with self-reported joint… Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Joint Pain, Stiffness, Function
- What is being tested?
- Instaflex
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female
- ages 50-75 years
- history (>3 months) joint pain, knees, hip, ankles, shoulders, or hands
- willingness to avoid NSAIDs use during the 8-week study
- willingness to avoid other anti-inflammatory medications
- agree to stay weight stable during the 8-week study
- willing to follow all study procedures, including randomization to one of two groups
- able to walk for at least 6 min at a moderate-to-brisk pace
Who cannot join
- history of regular NSAID use during the previous two weeks
- use of other medications (e.g., analgesic gels, arthritis medications, other anti-inflammatory drugs) or supplements (in particular, glucosamine and chondroitin) for joint pain for the previous two weeks
- serious medical problems (current cancer case, severe rheumatoid arthritis, recent heart attack, recent stroke, congestive heart failure, ulcers, kidney disease, or other disease that will interfere with study participation).
- psychiatric disorder or other condition that might interfere with self-assessment ability.
- history of allergic reactions to shellfish products.
- history of allergic reactions to products containing aspirin.
Trial locations and contacts
1 site in 1 country.
United States1 site
ASU Human Performance Laboratory, North Carolina Research Campus
Kannapolis, North Carolina, 28081
About this study
Official title: Influence of Instaflex Joint Support Supplement on Joint Pain, Stiffness, Function, and Inflammation: a Randomized, Placebo-controlled Community Trial
The primary purpose of this study is to assess the effect of 8-weeks ingestion of the Instaflex Joint Support supplement (Direct Digital, Charlotte, NC) compared to placebo on joint pain, stiffness, and function (questionnaires and 6-min walk test) and blood inflammation biomarkers in adults with self-reported joint pain.
Read the detailed description
Allocation: Randomized. Subjects will be randomized to one of two groups: placebo or Instaflex Joint Support. Supplements will be administered in double-blinded fashion.
Intervention Model: Instaflex Joint Support supplement for 8 weeks versus placebo.
Sample Size: N=100, with N=50 per group.
Statistical Procedures: 2 x 2 repeated measures analysis of variance (ANOVA).
Study Duration (per subject): 8 weeks.
Blood sample schedule: Blood draws pre- and post-study.
Monitoring adverse events: Subjects will fill in bi-weekly symptom logs to monitor untoward symptoms. Diagnostic chemistry panels will be measured pre- and post-study.
Rescue medication: Paracetamol (i.e., acetaminophen as found in Tylenol) will be allowed as a rescue medicine for pain during the study as needed. Subjects will record paracetamol usage. Paracetamol can relieve pain in mild arthritis but has no effect on the underlying inflammation, redness, and swelling of the joint.
Lab visit testing sequence (at the Kannapolis YMCA, in the afternoon by appointment.):
- First visit:
- Consent form
- Medical health questionnaire to verify medical history, and lifestyle habits.
- Symptoms log for previous 2-weeks symptomatology
- Height, weight, and percent body fat (bioelectrical impedance, Tanita scale)
- Questionnaires: Western Ontario and McMaster Universities Arthritis Index (WOMAC), Short Form (36) Health Survey (SF-36), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP).
- Blood sample (followed by a glass of orange juice)
- 6-minute walk test (at the local YMCA track) (one practice trial, and then repeat for test).
- Receive supplement organizer tray with 8-weeks supply (and instructions)
- 8-week study:
- Subjects will be contacted via email every 2 weeks to monitor compliance and fill in symptom logs.
- Second lab visit:
- Same as first lab visit, except for removal of steps "a,b, and h".
Supplements:
Supplements (Instaflex, placebo) will be prepared in colored gel capsules (3 per day, identical looking), and given to the subjects in supplement organizer trays. Subjects will take 3 capsules/day: one capsule each in the morning, at noontime, and in the evening. The placebo capsules will contain magnesium stearate, an inert substance.
Compliance:
Compliance will be monitored with bi-weekly email messages, and by counting unused capsules when subjects return the supplement trays at the end of the 8-week study. If subjects miss one, two, or three days of taking supplements, subjects will be asked to double up usage until back on schedule. Subjects missing more than three days of taking the supplements will be asked to leave the study.
- Instaflex Joint Support Supplement
A serving size is 3 capsules, and contains the following ingredients:
Glucosamine Sulfate 1500 mg Methylsulfonylmethane 500 mg White Willow Bark Extract (standardized to 15% salicin) 250 mg Ginger Root Concentrate 50 mg Boswella Serrata Extract (Standardized to 65% boswellic acid) 125 mg Turmeric Root Extract 50 mg Cayenne 40m H.U. 50 mg Hyaluronic Acid 4.0 mg Other Ingredients: Rice Flour, Gelatin, Vegetable Magnesium Stearate, Silicon Dioxide
- Conditions
- Joint Pain, Stiffness, Function
- Being tested
- Instaflex, Placebo
- Keywords
- glucosamine, inflammation, quality of life, physical function
- Medical subject headings
- Arthralgia, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InstaflexDietary supplement
Also called Instaflex Joint Support dietary supplement
The Instaflex supplement contained the following ingredients (in 3 capsules): Glucosamine sulfate (1500 mg), methylsulfonylmethane (MSM) (500 mg), white willow bark extract (standardized to 15% salicin) (250 mg), ginger root concentrate (50 mg), boswella serrata extract (standardized to 65% boswellic acid) (125 mg), turmeric root extract (50 mg), cayenne 40m H.U. (50 mg), and hyaluronic acid (4.0 mg).
PlaceboDietary supplement
Also called Placebo supplement
The placebo capsules will contain magnesium stearate, an inert substance.
| Study group | Role | What they receive |
|---|---|---|
| Instaflex | Experimental | Instaflex Joint Support supplement (3 capsules per day for 8 weeks) Receives: Dietary Supplement: Instaflex |
| Placebo | Placebo comparator | Placebo (3 capsules per day for 8 weeks) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Joint pain and function
Assessed through questionnaires
Measured: Change in joint pain and function at 8 weeks
Secondary outcomes (2)
Systemic inflammation
Serum CRP and plasma cytokines (9 total)
Measured: Change in systemic inflammation at 8 weeks
Safety
Symptoms logs and diagnostic chemistries
Measured: Change in safety outcomes at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startApr 2013
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Joint Pain, Stiffness, FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Appalachian State University
- Sponsor type
- University, hospital or other
- Collaborators
- Direct Digital
- Responsible party
- Sponsor
- Investigators
- David C. Nieman, DrPH, Principal investigator, Appalachian State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01956500
- Sponsor's protocol ID
- 13-0173
- Status last verified
- Oct 2013
- First submitted
- 27 Sep 2013
- Last updated
- 8 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Nieman DC, Shanely RA, Luo B, Dew D, Meaney MP, Sha W. A commercialized dietary supplement alleviates joint pain in community adults: a double-blind, placebo-controlled community trial. Nutr J. 2013 Nov 25;12(1):154. doi: 10.1186/1475-2891-12-154.
PubMed 24274358
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Instaflex Joint Support Supplement on Joint Pain, Stiffness, Function, and Inflammation: a Randomized, Placebo-controlled Community Trial
- ClinicalTrials.gov ID
- NCT01956500
- Acronym / sponsor ID
- 13-0173
- Conditions
- Joint Pain, Stiffness, Function
- Keywords
- glucosamine, inflammation, quality of life, physical function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Appalachian State UniversityUniversity, hospital or other
- Collaborators
- Direct Digital
- Study start
- Apr 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 8 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to assess the effect of 8-weeks ingestion of the Instaflex Joint Support supplement (Direct Digital, Charlotte, NC) compared to placebo on joint pain, stiffness, and function (questionnaires and 6-min walk test) and blood inflammation biomarkers in adults with self-reported joint pain.
Detailed description
Allocation: Randomized. Subjects will be randomized to one of two groups: placebo or Instaflex Joint Support. Supplements will be administered in double-blinded fashion.
Intervention Model: Instaflex Joint Support supplement for 8 weeks versus placebo.
Sample Size: N=100, with N=50 per group.
Statistical Procedures: 2 x 2 repeated measures analysis of variance (ANOVA).
Study Duration (per subject): 8 weeks.
Blood sample schedule: Blood draws pre- and post-study.
Monitoring adverse events: Subjects will fill in bi-weekly symptom logs to monitor untoward symptoms. Diagnostic chemistry panels will be measured pre- and post-study.
Rescue medication: Paracetamol (i.e., acetaminophen as found in Tylenol) will be allowed as a rescue medicine for pain during the study as needed. Subjects will record paracetamol usage. Paracetamol can relieve pain in mild arthritis but has no effect on the underlying inflammation, redness, and swelling of the joint.
Lab visit testing sequence (at the Kannapolis YMCA, in the afternoon by appointment.):
- First visit:
- Consent form
- Medical health questionnaire to verify medical history, and lifestyle habits.
- Symptoms log for previous 2-weeks symptomatology
- Height, weight, and percent body fat (bioelectrical impedance, Tanita scale)
- Questionnaires: Western Ontario and McMaster Universities Arthritis Index (WOMAC), Short Form (36) Health Survey (SF-36), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP).
- Blood sample (followed by a glass of orange juice)
- 6-minute walk test (at the local YMCA track) (one practice trial, and then repeat for test).
- Receive supplement organizer tray with 8-weeks supply (and instructions)
- 8-week study:
- Subjects will be contacted via email every 2 weeks to monitor compliance and fill in symptom logs.
- Second lab visit:
- Same as first lab visit, except for removal of steps "a,b, and h".
Supplements:
Supplements (Instaflex, placebo) will be prepared in colored gel capsules (3 per day, identical looking), and given to the subjects in supplement organizer trays. Subjects will take 3 capsules/day: one capsule each in the morning, at noontime, and in the evening. The placebo capsules will contain magnesium stearate, an inert substance.
Compliance:
Compliance will be monitored with bi-weekly email messages, and by counting unused capsules when subjects return the supplement trays at the end of the 8-week study. If subjects miss one, two, or three days of taking supplements, subjects will be asked to double up usage until back on schedule. Subjects missing more than three days of taking the supplements will be asked to leave the study.
- Instaflex Joint Support Supplement
A serving size is 3 capsules, and contains the following ingredients:
Glucosamine Sulfate 1500 mg Methylsulfonylmethane 500 mg White Willow Bark Extract (standardized to 15% salicin) 250 mg Ginger Root Concentrate 50 mg Boswella Serrata Extract (Standardized to 65% boswellic acid) 125 mg Turmeric Root Extract 50 mg Cayenne 40m H.U. 50 mg Hyaluronic Acid 4.0 mg Other Ingredients: Rice Flour, Gelatin, Vegetable Magnesium Stearate, Silicon Dioxide
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Instaflex | Experimental | Dietary Supplement: InstaflexInstaflex Joint Support supplement (3 capsules per day for 8 weeks) |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo (3 capsules per day for 8 weeks) |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female
- ages 50-75 years
- history (>3 months) joint pain, knees, hip, ankles, shoulders, or hands
- willingness to avoid NSAIDs use during the 8-week study
- willingness to avoid other anti-inflammatory medications
Key exclusion criteria (6 listed)
- history of regular NSAID use during the previous two weeks
- use of other medications (e.g., analgesic gels, arthritis medications, other anti-inflammatory drugs) or supplements (in particular, glucosamine and chondroitin) for joint pain for the previous two weeks
- serious medical problems (current cancer case, severe rheumatoid arthritis, recent heart attack, recent stroke, congestive heart failure, ulcers, kidney disease, or other disease that will interfere with study participation).
- psychiatric disorder or other condition that might interfere with self-assessment ability.
- history of allergic reactions to shellfish products.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InstaflexAlso: Instaflex Joint Support dietary supplementThe Instaflex supplement contained the following ingredients (in 3 capsules): Glucosamine sulfate (1500 mg), methylsulfonylmethane (MSM) (500 mg), white willow bark extract (standardized to 15% salicin) (250 mg), ginger root concentrate (50 mg), boswella serrata extract (standardized to 65% boswellic acid) (125 mg), turmeric root extract (50 mg), cayenne 40m H.U. (50 mg), and hyaluronic acid (4.0 mg). | Dietary supplement | Instaflex |
| PlaceboAlso: Placebo supplementThe placebo capsules will contain magnesium stearate, an inert substance. | Dietary supplement | Placebo |
Primary outcome
Joint pain and function
Time frame: Change in joint pain and function at 8 weeks
Assessed through questionnaires
2 secondary outcomes
Systemic inflammation
Time frame: Change in systemic inflammation at 8 weeks
Safety
Time frame: Change in safety outcomes at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2013.
- Derived from this study: PubMed 24274358Nieman DC, Shanely RA, Luo B, Dew D, Meaney MP, Sha W. A commercialized dietary supplement alleviates joint pain in community adults: a double-blind, placebo-controlled community trial. Nutr J. 2013 Nov 25;12(1):154. doi: 10.1186/1475-2891-12-154.
- Lab web siteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David C. Nieman, DrPH principal investigator
Appalachian State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Instaflex in people with Joint Pain, Stiffness, Function, run by Appalachian State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Joint pain and function (time frame: Change in joint pain and function at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01956500, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2013.