Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
110 participants
INTERVENTIONAL
2013-04-30
2013-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.):
1. First visit:
1. Consent form
2. Medical health questionnaire to verify medical history, and lifestyle habits.
3. Symptoms log for previous 2-weeks symptomatology
4. Height, weight, and percent body fat (bioelectrical impedance, Tanita scale)
5. 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).
6. Blood sample (followed by a glass of orange juice)
7. 6-minute walk test (at the local YMCA track) (one practice trial, and then repeat for test).
8. Receive supplement organizer tray with 8-weeks supply (and instructions)
2. 8-week study:
a. Subjects will be contacted via email every 2 weeks to monitor compliance and fill in symptom logs.
3. Second lab visit:
1. 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.
1\. 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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Instaflex
Instaflex Joint Support supplement (3 capsules per day for 8 weeks)
Instaflex
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).
Placebo
Placebo (3 capsules per day for 8 weeks)
Placebo
The placebo capsules will contain magnesium stearate, an inert substance.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Instaflex
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).
Placebo
The placebo capsules will contain magnesium stearate, an inert substance.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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.
50 Years
75 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Direct Digital
INDUSTRY
Appalachian State University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
David C. Nieman, DrPH
Role: PRINCIPAL_INVESTIGATOR
Appalachian State University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
ASU Human Performance Laboratory, North Carolina Research Campus
Kannapolis, North Carolina, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Related Links
Access external resources that provide additional context or updates about the study.
Lab web site
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
13-0173
Identifier Type: -
Identifier Source: org_study_id