Influence of Instaflex Joint Support Supplement on Joint Pain, Stiffness, Function, and Inflammation: a Randomized, Placebo-controlled Community Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Appalachian State University
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Joint pain and function
Study Overview
Brief 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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Arms & Interventions
Instaflex
Instaflex Joint Support supplement (3 capsules per day for 8 weeks)
Intervention: Instaflex (Dietary Supplement)
Placebo
Placebo (3 capsules per day for 8 weeks)
Intervention: Placebo (Dietary Supplement)
Outcomes
Primary Outcomes
Joint pain and function
Time Frame: Change in joint pain and function at 8 weeks
Assessed through questionnaires
Secondary Outcomes
- Systemic inflammation(Change in systemic inflammation at 8 weeks)
- Safety(Change in safety outcomes at 8 weeks)