Effect of Collavant® n2 in Healthy Male Adults With Exercise-induced Joint Discomfort.

NCT07561203 | Not Yet Recruiting

• 1 other identifier: PJ-00186 / COLLMOTION
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The present clinical study has been designed to evaluate the effect of Collavant® n2 at a daily dose of 40 mg on joint function and performance in healthy, amateur male runners with exercise-induced knee discomfort.

Conditions

Healthy Adult Male

Keywords

Native type II collagen; Undenatured type II collagen; Collavant® n2; Joint discomfort; Knee discomfort; Joint function; Cartilage biomarkers; Healthy active adults; Amateur runners; Knee function; Exercise-induced joint discomfort

Outcome Measures

Primary Outcomes (1)

• Change in Exercise-Induced Knee Joint Discomfort

  Joint discomfort will be assessed using a Visual Analogue Scale (VAS) to quantify knee pain intensity associated with physical activity. The primary endpoint is the change in knee joint discomfort from baseline, comparing Collavant® n2 versus placebo. VAS scores will be collected under standardized conditions after the running test, to capture exercise-induced discomfort.

  Baseline (week 0) to week 24

Secondary Outcomes (8)

• Change in joint pain intensity after physical activity

  Baseline (week 0) to week 12

• Change in joint pain intensity before physical activity

  Baseline (week 0) to week 12, baseline (week 0) to week 24

• Time to recovery of knee pain after exercise

  Baseline (week 0) to week 12, baseline (week 0) to week 24

• Change in physical performance during the running test

  Baseline (week 0) to week 12, baseline (week 0) to week 24

• Change in perceived exertion during physical activity

  Baseline (week 0) to week 12, baseline (week 0) to week 24

Other Outcomes (8)

• Change in clinical knee examination

  Baseline (week 0) to week 12, baseline (week 0) to week 24

• Incidence of Adverse Events

  Baseline (week 0) to week 24

• Changes in Vital Signs

  Baseline (week 0) to week 24

Study Arms (2)

Collavant® n2

EXPERIMENTAL

Native type II collagen (Collavant® n2)

Dietary Supplement: Native type II collagen (Collavant® n2)

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Native type II collagen (Collavant® n2) DIETARY_SUPPLEMENT

Native type II collagen (Collavant® n2). 1 capsule 40 mg / day

Collavant® n2

Placebo OTHER

Placebo. 1 capsule / day

Placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Gender Eligibility Details: Male gender
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy physically active male adults (amateur runners) with exercise-induced joint discomfort, aged between 40 and 65 years
• Activity level: Amateur runners who train regularly a minimum of 150 minutes per week, divided into 2 or more sessions per week during at least 3 months. Principally, subjects training for popular running events of 10 Kms.
• Joint discomfort after activity: Self-reports target knee discomfort after training by a score of at least 20 mm VAS at screening. Discomfort persistent for at least 2w.
• Be willing to refrain from starting any new dietary supplements during the entire study that have any underlying joint benefits (collagen, glucosamine, chondroitin, MSM, Hyaluronic Acid, Turmeric, Natural Eggshell Membrane, Omega-3 fatty acids, PEA, Boswellia,..). If any of these supplements (except collagen) or any other dietary supplement has been taken consistently for at least 6 months prior to enrollment, participants should maintain the same stable intake pattern throughout the 24 week study period.
• Have individual devices to monitor training with GPS
• Sign informed consent

You may not qualify if:

• Diagnostic of knee osteoarthritis or any pathology or surgical intervention associated with the knee.
• Hypersensitivity to any component of the supplement or the placebo
• Chronic treatment with analgesic or anti-inflammatory (NSAIDs and corticosteroids families) drugs
• Treatment with any type of collagen supplement
• Treatment with probiotics or antibiotics
• Inability to train for the next 24 weeks
• Follow a vegan diet

Sponsors & Collaborators

• Bioiberica: lead
• Universidad Politecnica de Madrid: collaborator

Study Sites (1)

Universidad Politecnica de Madrid

Madrid, Madrid, 28040, Spain

Location

Study Officials

• Marcela González-Gross, Professor

  Universidad Politecnica de Madrid

  PRINCIPAL INVESTIGATOR

• Javier Modrego-Martin, Doctor

  Universidad Politecnica de Madrid

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mónica García-López, Doctor

CONTACT

+34 93 765 03 90; monicagarcia@bioiberica.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: May 1, 2026
• Study Start: April 13, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)