Evaluation of the Effect of a Food Supplement Based on Hydrolyzed Collagen on Joint Function.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2024-06-30

Brief Summary

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This clinical study evaluates the effect of taking a hydrolyzed collagen-based supplement on pain, function and quality of life in a moderately physically active population. Non-pathological knee pain is a common occurrence in many healthy people and can limit the quality of life. Therefore, the resolution of this problem can bring many benefits in terms of quality of life.

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Detailed Description

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Study design

Randomized, double-blind, placebo-controlled clinical trial with 2 parallel study groups (collagen-based formulation and placebo). Participants will take the study products for 12 weeks.

Conditions

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Pain, Acute Pain, Chronic Knee Osteoarthritis Knee Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized parallel study will be conducted in which 80 subjects will be divided into 2 groups: COL) 10 g/d hydrolyzed collagen-based supplement; PLA) 10 g/d placebo (maltodextrin) for 12 weeks.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

triple-blind

Study Groups

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COLLAGEN (COL)

Subjects in this group will intake 10 g/day of a hydrolyzed collagen-based supplement.

Group Type EXPERIMENTAL

COLLAGEN (COL)

Intervention Type DIETARY_SUPPLEMENT

The collagen-based supplement will be ingested every day for 12 weeks at the same time.

PLACEBO (PLA)

Subjects in this group will intake 10 g/day of placebo (maltodextrin).

Group Type PLACEBO_COMPARATOR

PLACEBO (PLA)

Intervention Type DIETARY_SUPPLEMENT

The placebo will be ingested every day for 12 weeks at the same time.

Interventions

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COLLAGEN (COL)

The collagen-based supplement will be ingested every day for 12 weeks at the same time.

Intervention Type DIETARY_SUPPLEMENT

PLACEBO (PLA)

The placebo will be ingested every day for 12 weeks at the same time.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Individuals who exercise regularly and meet the WHO definition of being moderately active.
* Persistent exercise-associated knee pain lasting at least 2 months prior to study inclusion.
* Knee pain score on the visual analogue pain scale of at least 30 mm, taking into account that the scale has a maximum range of 100 mm.

Exclusion Criteria

* Individuals with severe illness.
* Subjects who are taking or have been treated within the last 7 days with glucosamine, chondroitin sulphate, collagen or hyaluronic acid injections or any dietary supplement indicated for joint health.
* Subjects with chronic inflammatory diseases affecting the musculoskeletal apparatus.
* Subjects with obesity (BMI ≥ 30 Kg/m2).
* Allergy or known hypersensitivity to any of the ingredients in the investigational product.
* Phenylketonuria.
* Treatment with narcotics, steroidal anti-inflammatory drugs or immunosuppressants. - Symptoms of extreme pain requiring high doses of analgesic therapy for a period of time longer than 2 weeks or intra-articular injection treatment.
* Individuals with diabetes.
* Pregnant women.
* Lactating women.
* Subjects who are participating in a clinical trial.
* Subjects who have participated in a clinical trial for pain in the last month.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes