CompletedNot Applicable

Influence of Instaflex Advanced Supplement on Joint Function

United States66 participantsStarted 2017-02-01

Plain-language 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. 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.

Who can participate

Age range

50 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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-mel…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in WOMAC total score

Timeframe: Change from baseline WOMAC total score at 4 weeks, 8 weeks, 12 weeks

Trial details

NCT IDNCT03041077

SponsorAppalachian State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-06-30

View on ClinicalTrials.gov More Knee Discomfort trials