NAtive Collagen Type II In Healthy VoluntEers With Joint Discomfort

NCT05282992 | Completed

• 1 other identifier: PJ-00081
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Joint Pain

Outcome Measures

Primary Outcomes (1)

• Change in joint discomfort onset

  Determine differences from baseline on reaching a joint pain of 5/1 while going up and down stairs (max 10 min).

  Change in joint discomfort onset at 6 months

Secondary Outcomes (6)

• Joint discomfort

  Day 0 to day 60, 90, 120, 180

• Joint function

  Day 0 to day 60, 90, 120, 180

• Time to Joint discomfort

  Day 0 to day 60, 90, 120, 180

• 6 minute walking timed test (6MWT)

  Day 0 and 180

• Rescue medication consumption

  Day 0 to 180, anytime

Other Outcomes (6)

• Daily activity levels

  Day 0 to 180, anytime

• Muscle quality

  Day 0 and 180

• Safety assessment

  Day 0 to 180, anytime

Study Arms (2)

Native type II collagen

EXPERIMENTAL

Native type II collagen

Dietary Supplement: Native type II collagen

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

Native type II collagen DIETARY_SUPPLEMENT

1 capsule/day

Native type II collagen

Placebo DIETARY_SUPPLEMENT

1 capsule/day

Placebo

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and non-pregnant females 30-65 years old with a Body Mass Index (BMI) of approximately 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 excluded medications.
• Reach joint discomfort of 5/10 on a 11-point Likert scale ( score 0 to 10) within 10 minutes of going up and down stairs.
• Clinical laboratory results that are within normal range or considered not clinically significant by the Principal Investigator.
• Be willing to participate in all scheduled visits, tests, and other trial procedures according to the clinical protocol. To do so and be able of using the fitness tracker, 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-steroidal anti-inflammatory drugs (NSAIDs), or any other pain reliever (OTC (Over the Counter) or prescription) during the entire study other than acetaminophen (paracetamol) as rescue medication.
• Provide a signed and dated informed consent indicating that the subject has been informed of all pertinent aspects and possible risks associated with participation in the study.
• Be willing to refrain from taking dietary supplements during the entire study that have any underlying joint benefit (collagen, glucosamine, chondroitin, MSM, Hyaluronic Acid, Turmeric, Natural Eggshell Membrane, Omega-3 fatty acids, PEA, Boswellia,…)

You may not qualify if:

• History of hypersensitivity to the rescue medication or any of the products used in the 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 (Rheumatoid Arthritis), 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, or malignancies 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.

Sponsors & Collaborators

• Bioiberica: lead

Study Sites (1)

Instituto Poal de Reumatología

Barcelona, Spain

Location

MeSH Terms

Conditions

Arthralgia

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: March 16, 2022
• Study Start: March 3, 2022
• Primary Completion: November 14, 2023
• Study Completion: March 18, 2024
• Last Updated: August 29, 2024

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)