Influence of Instaflex Advanced Supplement on Joint Function

NCT03041077 | Completed

• 1 other identifier: 17-0081
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Discomfort

Outcome Measures

Primary Outcomes (1)

• Change in WOMAC total score

  WOMAC questionnaire responses pre-study, 4 weeks, 8 weeks, 12 weeks

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

Secondary Outcomes (4)

• WOMAC subscales of pain, stiffness, and physical function

  Change from baseline WOMAC subscales at 4 weeks, 8 weeks, 12 weeks

• Visual Pain Scale

  Change from baseline visual pain scale at 4 weeks, 8 weeks, 12 weeks

• Profile of Mood States (POMS)

  Change from baseline POMS at 4 weeks, 8 weeks, 12 weeks

• 6 minute Walk Test

  Change from baseline 6 minute walk test at 4 weeks, 8 weeks, 12 weeks

Study Arms (2)

Instaflex Advanced

EXPERIMENTAL

Dietary supplement: Joint function

Dietary Supplement: Instaflex Advanced

Placebo

PLACEBO COMPARATOR

Dietary supplement: Placebo

Dietary Supplement: Placebo

Interventions

Instaflex Advanced DIETARY_SUPPLEMENT

Joint function

Instaflex Advanced

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

• Age: 50 Years - 75 Years
• Gender Eligibility Details: Self-reported on questionnaire
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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-melanoma skin cancer), severe rheumatoid arthritis, ulcers, kidney disease, psychiatric disorder.
• For female subjects: Pregnant or nursing, or planning to be pregnant or nursing during the study.
• On a weight loss program during the study.
• Vegetarian or vegan.

Sponsors & Collaborators

• Appalachian State University: lead
• Direct Digital: collaborator

Study Sites (1)

Appalachian State University Human Performance Lab, North Carolina Research Campus

Kannapolis, North Carolina, 28081, United States

Location

Study Officials

• David C Nieman, DrPH

  Appalachian State University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 1, 2017
• First Posted: February 2, 2017
• Study Start: February 1, 2017
• Primary Completion: June 30, 2017
• Study Completion: September 30, 2017
• Last Updated: January 23, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)