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

Francisco Javier Martínez Noguera

Status: Enrolling

Conditions: Knee Injuries; Pain, Acute; Pain, Chronic; Knee Osteoarthritis

Treatments: Dietary Supplement: COLLAGEN (COL); Dietary Supplement: PLACEBO (PLA)

Study type: Interventional

Funder types: Other

Identifiers

NCT05917925

CE012308

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

COLLAGEN (COL)

Experimental group

Description:

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

Treatment:

Dietary Supplement: COLLAGEN (COL)

PLACEBO (PLA)

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: PLACEBO (PLA)