Influence of Instaflex Advanced Supplement on Joint Function

Knee Discomfort Clinical Trial

Official title: Influence of Instaflex Advanced Supplement on Joint Function: A Randomized, Placebo-controlled Community Trial

Status Completed

Clinical Trial 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.

Clinical Trial Description

The research procedures will be conducted at the Human Performance Laboratory (Room 1201, Plants for Human Health Institute Building, 600 Laureate Way), operated by Appalachian State University at the North Carolina Research Campus (NCRC) in Kannapolis, NC. Subjects will come here for orientation/baseline testing and then 3 other lab visits (each session will take about 30 minutes). The total amount of time study participants will be asked to volunteer for this study is about 2 hours at the Human Performance Laboratory (over a 12-week period). Participants will also take a daily supplement for 12 weeks and keep compliant with this regimen.

Lab visit testing sequence:

1. First visit:

1. Consent form

2. Medical health questionnaire to verify medical history, and lifestyle habits.

3. Questionnaire for previous 4-weeks symptoms.

4. Height, weight, and percent body fat (BIA).Testing will take place behind a screened area of the lab to maintain privacy.

5. Questionnaires: WOMAC, visual pain scale, POMS.

6. Receive supplement organizer tray with 4-weeks supply (and instructions).

7. After a practice trial, study participants will walk as quickly and far as they can on a track for 6 minutes. Total distance covered in 6 minutes will be recorded.

2. 4 weeks, 8-weeks, 12 weeks (second, third, and fourth lab visits):

1. Symptoms log for previous 4-weeks symptomatology.

2. Height, weight, and percent body fat.

3. Questionnaires: WOMAC, visual pain scale, POMS.

4. Receive supplement organizer tray with 4-weeks supply (and instructions) during second and third lab visits.

5. 6-minute walk test

Supplements:

Supplements (Instaflex Advanced, placebo) will be contained in identical looking capsules and organized by day of the week in supplement organizer trays. Study participants will take 1 capsule each day in the morning. The placebo capsules contain magnesium stearate, an inert substance. The Instaflex Advanced supplement ingredients include: turmeric, resveratrol, Boswellia serrata, collagen, hyaluronic acid, and black pepper extract. Compliance will be monitored with bi-weekly email messages, and by counting unused capsules when the supplement trays every 4 weeks. Acetaminophen, as found in Tylenol, will be allowed as a rescue medicine for pain during the study as needed. ;

Related Conditions & MeSH terms

• Knee Discomfort

• NCT number: NCT03041077
• Study type: Interventional
• Source: Appalachian State University
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Completion date: September 30, 2017