Clinical trial NCT01956500: Instaflex and Joint Pain in Community Adults
Official title: Influence of Instaflex Joint Support Supplement on Joint Pain, Stiffness, Function, and Inflammation: a Randomized, Placebo-controlled Community Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Joint Pain, Stiffness, Function
Keywords: glucosamine
inflammation
quality of life
physical function
Lead sponsor: Appalachian State University
Sponsor class: OTHER
Collaborators: name: Direct Digital
First posted: 2013-10-08
Enrollment: 110
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Joint pain and function
timeFrame: Change in joint pain and function at 8 weeks
Secondary outcomes:
measure: Systemic inflammation
timeFrame: Change in systemic inflammation at 8 weeks
measure: Safety
timeFrame: Change in safety outcomes at 8 weeks
Other outcomes:
Locations:
city: Kannapolis
country: United States
facility: ASU Human Performance Laboratory, North Carolina Research Campus
state: North Carolina
Study officials:
affiliation: Appalachian State University
name: David C. Nieman, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.