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

August 28, 2024 updated by: Bioiberica

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Spain
      • Barcelona, Spain
        • Instituto Poal de Reumatología

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in joint discomfort onset
Time Frame: Change in joint discomfort onset at 6 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Joint discomfort
Time Frame: Day 0 to day 60, 90, 120, 180
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
Time Frame: Day 0 to day 60, 90, 120, 180
Knee injury and Osteoarthritis Outcome Score (KOOS) test
Day 0 to day 60, 90, 120, 180
Time to Joint discomfort
Time Frame: Day 0 to day 60, 90, 120, 180
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)
Time Frame: Day 0 and 180
Distance a person is capable of walking on a flat, hard surface in 6 minutes
Day 0 and 180
Rescue medication consumption
Time Frame: Day 0 to 180, anytime
Rescue medication: Paracetamol 500mg. max 2 pills/day
Day 0 to 180, anytime
Cartilage turnover biomarkers
Time Frame: Day 0 and 180
Cartilage turnover biomarkers will be measured in blood and urine (CTX-II, C2C, CPII)
Day 0 and 180

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Daily activity levels
Time Frame: Day 0 to 180, anytime
A fitness tracker will monitor the steps taken daily
Day 0 to 180, anytime
Muscle quality
Time Frame: Day 0 and 180
Muscle quality will be evaluated by an ultrasound index
Day 0 and 180
Safety assessment
Time Frame: Day 0 to 180, anytime
Adverse events
Day 0 to 180, anytime
Safety assessment
Time Frame: Day 0 to day 60, 90, 120, 180
Medical exams (weight in kilograms, height in meters, BMI in kg/m^2)
Day 0 to day 60, 90, 120, 180
Safety assessment
Time Frame: Day 0 to day 60, 90, 120, 180
Vital signs (heart rate in bpm and blood pressure mmHg)
Day 0 to day 60, 90, 120, 180
Safety assessment
Time Frame: Day 0 and 180
Laboratory analysis (total blood count, glucose, AST, ALT, Cholesterol, Creatinine, BUN, triglycerides, alkaline phosphatase)
Day 0 and 180

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bioiberica

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 3, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 14, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 18, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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