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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03041077
• Other study ID #: 17-0081
• Status: Completed
• Phase: N/A
• First received: February 1, 2017
• Last updated: January 19, 2018
• Start date: February 1, 2017
• Est. completion date: September 30, 2017

Study information

• Verified date: January 2018
• Source: Appalachian State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: September 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Knee Discomfort

Intervention

Dietary Supplement:
• Instaflex Advanced
Joint function
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Appalachian State University Human Performance Lab, North Carolina Research Campus	Kannapolis	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Appalachian State University	Direct Digital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	WOMAC subscales of pain, stiffness, and physical function	WOMAC questionnaire subscale responses pre-study, 4 weeks, 8 weeks, 12 weeks	Change from baseline WOMAC subscales at 4 weeks, 8 weeks, 12 weeks
Secondary	Visual Pain Scale	10-point Likert-type scale for knee pain severity	Change from baseline visual pain scale at 4 weeks, 8 weeks, 12 weeks
Secondary	Profile of Mood States (POMS)	Assessment of mood state	Change from baseline POMS at 4 weeks, 8 weeks, 12 weeks
Secondary	6 minute Walk Test	Maximum distance covered during 6 minutes of walking	Change from baseline 6 minute walk test at 4 weeks, 8 weeks, 12 weeks