Knee DiscomfortNCT03041077
Influence of Instaflex Advanced Supplement on Joint Function
A study testing Instaflex Advanced in people with Knee Discomfort, run by Appalachian State University at 1 site in United States.
Trial summary
Joint discomfort is reported by 32% of U.S. adults, and increases with age. The knee is the most common site of joint discomfort regardless of age. Nearly half of people with knee joint discomfort use natural supplements to alleviate symptoms, but more research is needed to determine their effectiveness. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Discomfort
- What is being tested?
- Instaflex Advanced
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 30 Sep 2017
- 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 adult
- Age 50-75 years
- Self-reported history (>3 months) of joint discomfort in the knees. NOTE: the severity of knee discomfort will be determined through a questionnaire called the WOMAC, and should be at least 2 points (indicating mild knee discomfort or greater).
- No history of regular use of non-steroidal anti-inflammatory drugs (NSAIDs) use (e.g., ibuprofen, aspirin) during the previous two weeks, and willingness to avoid the use of NSAIDs during the 12-week study.
- Not on other medications (e.g., analgesic gels, arthritis medications, other anti-inflammatory drugs) or supplements (in particular, glucosamine and chondroitin) for joint discomfort during the previous two weeks, and a willingness to avoid use of these during the 12-week study.
- No serious medical problems (current cancer case, severe rheumatoid arthritis, recent heart attack, recent stroke, congestive heart failure, ulcers, kidney disease, or other disease that would interfere with study participation).
- No psychiatric disorder or other condition that might interfere with self-assessment ability.
- Willingness to follow all study procedures including randomization to one of two groups, and to stay weight stable during the study.
Who cannot join
- Inability to comply with study requirements including avoidance of NSAIDs, other anti-inflammatory medications, or discomfort supplements.
- Current diagnosis of cardiovascular disease, cancer (except for non-melanoma skin cancer), severe rheumatoid arthritis, ulcers, kidney disease, psychiatric disorder.
- For female subjects: Pregnant or nursing, or planning to be pregnant or nursing during the study.
- On a weight loss program during the study.
- Vegetarian or vegan.
Trial locations and contacts
1 site in 1 country.
United States1 site
Appalachian State University Human Performance Lab, North Carolina Research Campus
Kannapolis, North Carolina, 28081
About this study
Official title: Influence of Instaflex Advanced Supplement on Joint Function: A Randomized, Placebo-controlled Community Trial
Joint discomfort is reported by 32% of U.S. adults, and increases with age. The knee is the most common site of joint discomfort regardless of age. Nearly half of people with knee joint discomfort use natural supplements to alleviate symptoms, but more research is needed to determine their effectiveness. In a previous study, we measured the effect of 8-weeks ingestion of a commercialized joint support dietary supplement (InstaflexTM Joint Support, Direct Digital, Charlotte, NC) compared to placebo on joint discomfort, stiffness, and function in adults with self-reported joint discomfort. This study will be repeated using Instaflex Advanced, with a longer 12-week time period. The Instaflex Advanced supplement includes six products: turmeric, resveratrol, Boswellia serrata, collagen, hyaluronic acid, and black pepper extract. This unique blend may improve joint function and increase mobility, but has not yet been tested in humans using a randomized, double-blinded, placebo-controlled research design. The primary purpose of this study is to assess the effect of 12-weeks ingestion of the Instaflex Advanced supplement compared to placebo in improving knee function in adults with self-reported knee joint discomfort.
Read the detailed description
The research procedures will be conducted at the Human Performance Laboratory (Room 1201, Plants for Human Health Institute Building, 600 Laureate Way), operated by Appalachian State University at the North Carolina Research Campus (NCRC) in Kannapolis, NC. Subjects will come here for orientation/baseline testing and then 3 other lab visits (each session will take about 30 minutes). The total amount of time study participants will be asked to volunteer for this study is about 2 hours at the Human Performance Laboratory (over a 12-week period). Participants will also take a daily supplement for 12 weeks and keep compliant with this regimen.
Lab visit testing sequence:
- First visit:
- Consent form
- Medical health questionnaire to verify medical history, and lifestyle habits.
- Questionnaire for previous 4-weeks symptoms.
- Height, weight, and percent body fat (BIA).Testing will take place behind a screened area of the lab to maintain privacy.
- Questionnaires: WOMAC, visual pain scale, POMS.
- Receive supplement organizer tray with 4-weeks supply (and instructions).
- After a practice trial, study participants will walk as quickly and far as they can on a track for 6 minutes. Total distance covered in 6 minutes will be recorded.
- 4 weeks, 8-weeks, 12 weeks (second, third, and fourth lab visits):
- Symptoms log for previous 4-weeks symptomatology.
- Height, weight, and percent body fat.
- Questionnaires: WOMAC, visual pain scale, POMS.
- Receive supplement organizer tray with 4-weeks supply (and instructions) during second and third lab visits.
- 6-minute walk test
Supplements:
Supplements (Instaflex Advanced, placebo) will be contained in identical looking capsules and organized by day of the week in supplement organizer trays. Study participants will take 1 capsule each day in the morning. The placebo capsules contain magnesium stearate, an inert substance. The Instaflex Advanced supplement ingredients include: turmeric, resveratrol, Boswellia serrata, collagen, hyaluronic acid, and black pepper extract. Compliance will be monitored with bi-weekly email messages, and by counting unused capsules when the supplement trays every 4 weeks. Acetaminophen, as found in Tylenol, will be allowed as a rescue medicine for pain during the study as needed.
- Conditions
- Knee Discomfort
- Being tested
- Instaflex Advanced, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instaflex AdvancedDietary supplement
Joint function
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Instaflex Advanced | Experimental | Dietary supplement: Joint function Receives: Dietary Supplement: Instaflex Advanced |
| Placebo | Placebo comparator | Dietary supplement: Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in WOMAC total score
WOMAC questionnaire responses pre-study, 4 weeks, 8 weeks, 12 weeks
Measured: Change from baseline WOMAC total score at 4 weeks, 8 weeks, 12 weeks
Secondary outcomes (4)
WOMAC subscales of pain, stiffness, and physical function
WOMAC questionnaire subscale responses pre-study, 4 weeks, 8 weeks, 12 weeks
Measured: Change from baseline WOMAC subscales at 4 weeks, 8 weeks, 12 weeks
Visual Pain Scale
10-point Likert-type scale for knee pain severity
Measured: Change from baseline visual pain scale at 4 weeks, 8 weeks, 12 weeks
Profile of Mood States (POMS)
Assessment of mood state
Measured: Change from baseline POMS at 4 weeks, 8 weeks, 12 weeks
6 minute Walk Test
Maximum distance covered during 6 minutes of walking
Measured: Change from baseline 6 minute walk test at 4 weeks, 8 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study start1 Feb 2017
- Primary completion30 Jun 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee DiscomfortStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 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
- NCT03041077
- Sponsor's protocol ID
- 17-0081
- Status last verified
- Jan 2018
- First submitted
- 1 Feb 2017
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD sharing plan
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Instaflex Advanced Supplement on Joint Function: A Randomized, Placebo-controlled Community Trial
- ClinicalTrials.gov ID
- NCT03041077
- Acronym / sponsor ID
- 17-0081
- Conditions
- Knee Discomfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Appalachian State UniversityUniversity, hospital or other
- Collaborators
- Direct Digital
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 2 Feb 2017 (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.
Joint discomfort is reported by 32% of U.S. adults, and increases with age. The knee is the most common site of joint discomfort regardless of age. Nearly half of people with knee joint discomfort use natural supplements to alleviate symptoms, but more research is needed to determine their effectiveness. In a previous study, we measured the effect of 8-weeks ingestion of a commercialized joint support dietary supplement (InstaflexTM Joint Support, Direct Digital, Charlotte, NC) compared to placebo on joint discomfort, stiffness, and function in adults with self-reported joint discomfort. This study will be repeated using Instaflex Advanced, with a longer 12-week time period. The Instaflex Advanced supplement includes six products: turmeric, resveratrol, Boswellia serrata, collagen, hyaluronic acid, and black pepper extract. This unique blend may improve joint function and increase mobility, but has not yet been tested in humans using a randomized, double-blinded, placebo-controlled research design. The primary purpose of this study is to assess the effect of 12-weeks ingestion of the Instaflex Advanced supplement compared to placebo in improving knee function in adults with self-reported knee joint discomfort.
Detailed description
The research procedures will be conducted at the Human Performance Laboratory (Room 1201, Plants for Human Health Institute Building, 600 Laureate Way), operated by Appalachian State University at the North Carolina Research Campus (NCRC) in Kannapolis, NC. Subjects will come here for orientation/baseline testing and then 3 other lab visits (each session will take about 30 minutes). The total amount of time study participants will be asked to volunteer for this study is about 2 hours at the Human Performance Laboratory (over a 12-week period). Participants will also take a daily supplement for 12 weeks and keep compliant with this regimen.
Lab visit testing sequence:
- First visit:
- Consent form
- Medical health questionnaire to verify medical history, and lifestyle habits.
- Questionnaire for previous 4-weeks symptoms.
- Height, weight, and percent body fat (BIA).Testing will take place behind a screened area of the lab to maintain privacy.
- Questionnaires: WOMAC, visual pain scale, POMS.
- Receive supplement organizer tray with 4-weeks supply (and instructions).
- After a practice trial, study participants will walk as quickly and far as they can on a track for 6 minutes. Total distance covered in 6 minutes will be recorded.
- 4 weeks, 8-weeks, 12 weeks (second, third, and fourth lab visits):
- Symptoms log for previous 4-weeks symptomatology.
- Height, weight, and percent body fat.
- Questionnaires: WOMAC, visual pain scale, POMS.
- Receive supplement organizer tray with 4-weeks supply (and instructions) during second and third lab visits.
- 6-minute walk test
Supplements:
Supplements (Instaflex Advanced, placebo) will be contained in identical looking capsules and organized by day of the week in supplement organizer trays. Study participants will take 1 capsule each day in the morning. The placebo capsules contain magnesium stearate, an inert substance. The Instaflex Advanced supplement ingredients include: turmeric, resveratrol, Boswellia serrata, collagen, hyaluronic acid, and black pepper extract. Compliance will be monitored with bi-weekly email messages, and by counting unused capsules when the supplement trays every 4 weeks. Acetaminophen, as found in Tylenol, will be allowed as a rescue medicine for pain during the study as needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Instaflex Advanced | Experimental | Dietary Supplement: Instaflex AdvancedDietary supplement: Joint function |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboDietary supplement: Placebo |
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 adult
- Age 50-75 years
- Self-reported history (>3 months) of joint discomfort in the knees. NOTE: the severity of knee discomfort will be determined through a questionnaire called the WOMAC, and should be at least 2 points (indicating mild knee discomfort or greater).
- No history of regular use of non-steroidal anti-inflammatory drugs (NSAIDs) use (e.g., ibuprofen, aspirin) during the previous two weeks, and willingness to avoid the use of NSAIDs during the 12-week study.
- Not on other medications (e.g., analgesic gels, arthritis medications, other anti-inflammatory drugs) or supplements (in particular, glucosamine and chondroitin) for joint discomfort during the previous two weeks, and a willingness to avoid use of these during the 12-week study.
Key exclusion criteria (5 listed)
- Inability to comply with study requirements including avoidance of NSAIDs, other anti-inflammatory medications, or discomfort supplements.
- Current diagnosis of cardiovascular disease, cancer (except for non-melanoma skin cancer), severe rheumatoid arthritis, ulcers, kidney disease, psychiatric disorder.
- For female subjects: Pregnant or nursing, or planning to be pregnant or nursing during the study.
- On a weight loss program during the study.
- Vegetarian or vegan.
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 |
|---|---|---|
| Instaflex AdvancedJoint function | Dietary supplement | Instaflex Advanced |
| PlaceboPlacebo | Dietary supplement | Placebo |
Primary outcome
Change in WOMAC total score
Time frame: Change from baseline WOMAC total score at 4 weeks, 8 weeks, 12 weeks
WOMAC questionnaire responses pre-study, 4 weeks, 8 weeks, 12 weeks
4 secondary outcomes
WOMAC subscales of pain, stiffness, and physical function
Time frame: Change from baseline WOMAC subscales at 4 weeks, 8 weeks, 12 weeks
Visual Pain Scale
Time frame: Change from baseline visual pain scale at 4 weeks, 8 weeks, 12 weeks
Profile of Mood States (POMS)
Time frame: Change from baseline POMS at 4 weeks, 8 weeks, 12 weeks
6 minute Walk Test
Time frame: Change from baseline 6 minute walk test at 4 weeks, 8 weeks, 12 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 23 Jan 2018.
- Individual participant dataSharing planned: No. No IPD sharing plan
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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 Advanced in people with Knee Discomfort, 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 5 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 23 Jan 2018. 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?
Change in WOMAC total score (time frame: Change from baseline WOMAC total score at 4 weeks, 8 weeks, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2018.