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

NCT05917925 | Unknown

• 1 other identifier: CE012308
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Hydrolyzed collagen; Post-exercise pain; Supplementation; Inflammation; Quality of life

Outcome Measures

Primary Outcomes (1)

• Intensity of knee pain

  It will be measured using a 100 mm long horizontal visual analogue scale (VAS) on which the participant must mark the pain he/she feels with 0 being "none" and 100 being "the most intense pain he/she can imagine". Once the level of pain is marked on the horizontal line, the length is measured from 0 in millimetres with a millimetre ruler. The results will be evaluated according to three levels of pain based on the marked values: \<40 mm: Values below 40 mm indicate mild or mild moderate pain 40-60 mm: If the measurement is between 40 and 60 mm, the pain is considered moderate to moderate-severe \>60 mm: If the values are greater than 60 mm, the pain is considered severe to unbearable.

  Throughout study completion, an average of 12 weeks

Secondary Outcomes (14)

• Physical activity data

  The following data will be recorded during the baseline visit

• Demographic data

  The following data will be recorded during the baseline visit

• Frequency of alcohol and tobacco consumption

  The following data will be recorded during the baseline visit

• Weight

  The following data will be recorded during the baseline visit

• Height

  The following data will be recorded during the baseline visit

Study Arms (2)

COLLAGEN (COL)

EXPERIMENTAL

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

Dietary Supplement: COLLAGEN (COL)

PLACEBO (PLA)

PLACEBO COMPARATOR

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

Dietary Supplement: PLACEBO (PLA)

Interventions

COLLAGEN (COL) DIETARY_SUPPLEMENT

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

COLLAGEN (COL)

PLACEBO (PLA) DIETARY_SUPPLEMENT

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

PLACEBO (PLA)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Individuals who exercise regularly and meet the WHO definition of being moderately active.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Francisco Javier Martínez Noguera: lead
• San Antonio Technologies - San Antonio Catholic University of Murcia: collaborator

Study Sites (1)

Research Center for High Performance Sport. Catholic University of Murcia

La Ñora, Murcia, 30830, Spain

RECRUITING

Related Links

• Website

MeSH Terms

Conditions

Acute Pain; Chronic Pain; Osteoarthritis, Knee; Knee Injuries; Inflammation

Interventions

Collagen

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Leg Injuries; Wounds and Injuries; Pathologic Processes

Intervention Hierarchy (Ancestors)

Biopolymers; Polymers; Macromolecular Substances; Extracellular Matrix Proteins; Scleroproteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Francisco Javier Martínez Noguera, PhD

  Research Center for High Performance Sport. Catholic University of Murcia

  STUDY CHAIR

Central Study Contacts

Francisco Javier Martínez Noguera, PhD

CONTACT

968278566; fjmartinez3@ucam.edu

Cristian Marín Pagán, PhD

CONTACT

968278566; cmarin@ucam.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: triple-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD (Head of the nutrition area of the Research Center for High Performance Sport)

Model Details: 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.

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: June 26, 2023
• Study Start: April 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: June 1, 2024
• Last Updated: July 6, 2023

Record last verified: 2023-07

Locations

ES (1)