NAtive Collagen Type II In Healthy VoluntEers With Joint Discomfort

Last updated: August 28, 2024
Sponsor: Bioiberica
Overall Status: Completed

Phase

N/A

Condition

Arthritis And Arthritic Pain

Chronic Pain

Rheumatoid Arthritis

Treatment

Placebo

Native type II collagen

Clinical Study ID

NCT05282992
PJ-00081
  • Ages 30-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Collagen Supplement is a natural ingredient that contains native collagen derived from chicken sternum. Collagen Supplement is efficacious and safe on healthy subjects as compared to placebo.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Males and non-pregnant females 30-65 years old with a Body Mass Index (BMI) ofapproximately 18 to 30 kg/m2. (see Section 4.0)

  • Unilateral or bilateral knee discomfort for greater than 3 months.

  • VAS score during knee movement between 30-50 mm after 7-day withdrawal of excludedmedications.

  • Reach joint discomfort of 5/10 on a 11-point Likert scale ( score 0 to 10) within 10minutes of going up and down stairs.

  • Clinical laboratory results that are within normal range or considered notclinically significant by the Principal Investigator.

  • Be willing to participate in all scheduled visits, tests, and other trial proceduresaccording to the clinical protocol. To do so and be able of using the fitnesstracker, a phone or tablet compatible with the Fitbit app is required. (Apple iOS 12.2 or higher, Android OS 7.0 or higher.)

  • Be willing to refrain from taking ibuprofen, aspirin or other Non-steroidalanti-inflammatory drugs (NSAIDs), or any other pain reliever (OTC (Over the Counter)or prescription) during the entire study other than acetaminophen (paracetamol) asrescue medication.

  • Provide a signed and dated informed consent indicating that the subject has beeninformed of all pertinent aspects and possible risks associated with participationin the study.

  • Be willing to refrain from taking dietary supplements during the entire study thathave any underlying joint benefit (collagen, glucosamine, chondroitin, MSM,Hyaluronic Acid, Turmeric, Natural Eggshell Membrane, Omega-3 fatty acids, PEA,Boswellia,...)

Exclusion

Exclusion Criteria:

  • History of hypersensitivity to the rescue medication or any of the products used inthe study.

  • Requirement of drugs to control joint discomfort.

  • Regular drug intake to control any kind of pain.

  • History of hypersensitivity to eggs, chicken, or fowl.

  • History of Knee OA (OsteoArthritis), inflammatory arthropathy, RA (RheumatoidArthritis), OA (VAS score greater than 50), or Systemic Lupus Erythematosus.

  • Hyperuricemia (>440 μmol/L), history of gout, or both.

  • Exercising (intentionally) for more than 10 hours a week

  • High intensity exercise for more than 5 hours a week

  • Anticipation of surgery within the next 6 months.

  • Recent injury in the target knee (past 4 months).

  • History of congestive heart failure.

  • Anticipated problems with product consumption.

  • Evidence or history of clinically significant haematological, renal, endocrine,pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, ormalignancies within the last 5 years.

  • High alcohol intake (>2 standard drinks per day) or use of recreational drugs (e.g.,cocaine, methamphetamine, marijuana, etc.).

  • Females who are pregnant or lactating or planning to become pregnant.

  • History of any mental illness that might impair the ability of subjects to provide awritten informed consent.

  • Use of oral corticosteroid, indomethacin, SYSADOAs (symptomatic slow action drugosteoarthritis) within 3 months of Visit 1; topical treatment with corticosteroidswithin 1 week of visit 1, and consumption of Omega 3 fatty acids or any other jointhealth dietary supplements within 2 weeks preceding the treatment period.

  • Consumed, ibuprofen, aspirin or other NSAIDS, or any other pain reliever (OTC orprescription), or any natural health product, (excluding vitamins) within 7 days offirst visit.

  • Consumed acetaminophen (paracetamol) within 48 hours of randomization visit.

  • Participation in any clinical trials within 30 days prior to first visit.

  • Individuals following an energy restricted diet for weight loss

Study Design

Total Participants: 75
Treatment Group(s): 2
Primary Treatment: Placebo
Phase:
Study Start date:
March 03, 2022
Estimated Completion Date:
March 18, 2024

Study Description

This study will include 100 healthy volunteers in which will be evaluated if the collagen supplement is able to obtain differences versus placebo in pain and function. It will be a randomized, double-blind, placebo-controlled study with proportion 1:1 between treatments

Connect with a study center

  • Instituto Poal de Reumatología

    Barcelona,
    Spain

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.