NCT01956500

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 8, 2013

Completed
Last Updated

October 8, 2013

Status Verified

October 1, 2013

Enrollment Period

2 months

First QC Date

September 27, 2013

Last Update Submit

October 7, 2013

Conditions

Joint Pain, Stiffness, Function

Keywords

glucosamineinflammationquality of lifephysical function

Outcome Measures

Primary Outcomes (1)

  • Joint pain and function

    Assessed through questionnaires

    Change in joint pain and function at 8 weeks

Secondary Outcomes (2)

  • Systemic inflammation

    Change in systemic inflammation at 8 weeks

  • Safety

    Change in safety outcomes at 8 weeks

Study Arms (2)

Instaflex

EXPERIMENTAL

Instaflex Joint Support supplement (3 capsules per day for 8 weeks)

Dietary Supplement: Instaflex

Placebo

PLACEBO COMPARATOR

Placebo (3 capsules per day for 8 weeks)

Dietary Supplement: Placebo

Interventions

InstaflexDIETARY_SUPPLEMENT

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).

Also known as: Instaflex Joint Support dietary supplement
Instaflex
PlaceboDIETARY_SUPPLEMENT

The placebo capsules will contain magnesium stearate, an inert substance.

Also known as: Placebo supplement
Placebo

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ASU Human Performance Laboratory, North Carolina Research Campus

Kannapolis, North Carolina, 28081, United States

Location

Related Publications (1)

  • 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.

    PMID: 24274358DERIVED

Related Links

MeSH Terms

Conditions

ArthralgiaInflammation

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Study Officials

  • David C. Nieman, DrPH

    Appalachian State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2013

First Posted

October 8, 2013

Study Start

April 1, 2013

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

October 8, 2013

Record last verified: 2013-10

Locations

US(1)