NAtive Collagen Type II In Healthy VoluntEers With Joint Discomfort (ACTIVE)

A Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Tolerability of a Food Supplement in Healthy Volunteers With Joint Discomfort

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.

Study Overview

• Status: Completed
• Conditions: Joint Pain
• Intervention / Treatment: Dietary supplement: Native type II collagen; Dietary supplement: Placebo

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
    • Instituto Poal de Reumatología

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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,…)

Exclusion Criteria:

• 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.
• History of any mental illness that might impair the ability of subjects to provide a written informed consent.
• Use of oral corticosteroid, indomethacin, SYSADOAs (symptomatic slow action drug osteoarthritis) within 3 months of Visit 1; topical treatment with corticosteroids within 1 week of visit 1, and consumption of Omega 3 fatty acids or any other joint health dietary supplements within 2 weeks preceding the treatment period.
• Consumed, ibuprofen, aspirin or other NSAIDS, or any other pain reliever (OTC or prescription), or any natural health product, (excluding vitamins) within 7 days of first 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; 1 capsule/day
Experimental: Native type II collagen	Dietary supplement: Native type II collagen; 1 capsule/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Joint discomfort	Visual Analog Scale (VAS, 0-10cm) pain at rest and during activity. A higher VAS means higher pain levels	Day 0 to day 60, 90, 120, 180
Joint function	Knee injury and Osteoarthritis Outcome Score (KOOS) test	Day 0 to day 60, 90, 120, 180
Time to Joint discomfort	Time to joint discomfort and to recover from pain in 3 different exercises	Day 0 to day 60, 90, 120, 180
6 minute walking timed test (6MWT)	Distance a person is capable of walking on a flat, hard surface in 6 minutes	Day 0 and 180
Rescue medication consumption	Rescue medication: Paracetamol 500mg. max 2 pills/day	Day 0 to 180, anytime
Cartilage turnover biomarkers	Cartilage turnover biomarkers will be measured in blood and urine (CTX-II, C2C, CPII)	Day 0 and 180

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily activity levels	A fitness tracker will monitor the steps taken daily	Day 0 to 180, anytime
Muscle quality	Muscle quality will be evaluated by an ultrasound index	Day 0 and 180
Safety assessment	Adverse events	Day 0 to 180, anytime
Safety assessment	Medical exams (weight in kilograms, height in meters, BMI in kg/m^2)	Day 0 to day 60, 90, 120, 180
Safety assessment	Vital signs (heart rate in bpm and blood pressure mmHg)	Day 0 to day 60, 90, 120, 180
Safety assessment	Laboratory analysis (total blood count, glucose, AST, ALT, Cholesterol, Creatinine, BUN, triglycerides, alkaline phosphatase)	Day 0 and 180

Collaborators and Investigators

• Sponsor: Bioiberica

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2022
• Primary Completion (Actual): November 14, 2023
• Study Completion (Actual): March 18, 2024

Study Registration Dates

• First Submitted: February 23, 2022
• First Submitted That Met QC Criteria: March 7, 2022
• First Posted (Actual): March 16, 2022

Study Record Updates

• Last Update Posted (Actual): August 29, 2024
• Last Update Submitted That Met QC Criteria: August 28, 2024
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia
• Other Study ID Numbers: PJ-00081

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No