Chondractiv Move on Activity-related Joint Discomfort

NCT06714851 | Completed

• 1 other identifier: C1750
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

Joint discomfort, manifested as knee pain or gonalgia, is a common problem not only among athletes, but also among people who regularly take part in physical activities and sports. This discomfort can limit mobility and flexibility, even in healthy people who do not suffer from osteoarthritis or other joint diseases. Functional joint discomfort is also due to joint stress and the short-term deterioration of cartilage. The processes of cartilage formation and degradation lose their balance under load, and discomfort is felt for some time after exercise. These conditions and symptoms occur long before the onset of a disease such as osteoarthritis. Dietary supplements based on herbs or collagen derivatives (a protein involved in maintaining the structure of tissues, including those of the joints) are frequently used to alleviate the discomfort associated with joint disorders and improve the balance between cartilage synthesis and degradation. This study aims to assess the effect of the dietary supplement "Chondractiv Move" (named "Chondractiv Boost" at the time of protocol writing) on joint discomfort induced by physical activity. This is a combination of rosehip extract and hydrolyzed chicken cartilage containing collagen type II, chondroitin sulfate, and hyaluronic acid as main actives. This combination is chosen based on the results of studies showing the beneficial effects on joints of the ingredients.

Conditions

Joint; Derangement

Keywords

Activity-related joint discomfort; Collagen hydrolysate

Outcome Measures

Primary Outcomes (1)

• Change from baseline of activity-related joint discomfort at 8 weeks

  The pain-related activity is assessed by 0-10 Visual Analogic Scale (VAS) during SLSD (Single-Leg-Step-Down) test.

  Baseline (Day 0), 8 weeks (Day 56)

Secondary Outcomes (16)

• Change from baseline of activity-related joint discomfort at 4 weeks.

  Baseline (Day 0), 4 weeks (Day 28)

• Change from baseline of activity-related joint discomfort at 12 weeks

  Baseline (Day 0), 4 weeks (Day 84)

• Activity-related pain at regular exercise/physical activity

  Baseline (Day 0), 4 weeks (Day 84)

• Change from baseline on overall physical function at 2 weeks

  Baseline (Day 0), 2 weeks (Day 14)

• Change from baseline on overall physical function at 4 weeks

  Baseline (Day 0), 4 weeks (Day 28)

Other Outcomes (16)

• Change from baseline of experience of joint pain at 2 weeks

  Baseline (Day 0), 2 weeks (Day 14)

• Change from baseline of experience of joint pain at 4 weeks

  Baseline (Day 0), 4 weeks (Day 28)

• Change from baseline of experience of joint pain at 6 weeks

  Baseline (Day 0), 6 weeks (Day 42)

Study Arms (2)

Chondractiv Move

EXPERIMENTAL

8-week supplementation (12 weeks in ancillary subgroup) with 4 capsules/day

Dietary Supplement: Chondractiv Move

Placebo

PLACEBO COMPARATOR

8-week supplementation (12 weeks in ancillary subgroup) with 4 capsules/day

Other: Placebo

Interventions

Chondractiv Move DIETARY_SUPPLEMENT

The dietary supplement under study (Chondractiv Move) is a combination of 2 active ingredients: Hydrolyzed chicken cartilage and Rosehip extract at the dose of 1580 mg/day.

Chondractiv Move

Placebo OTHER

Placebo contains 100% maltodextrins as non-active agent at the dose of 1800 mg/day.

Placebo

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index ≥ 18.5 and \< 30.0 kg/m2.
• Physically active: joint bearing sports (i.e., but not limited to soccer, basketball, handball, volleyball, tennis, running) for at least 3 hours per week or 2 times per week.
• Who self-report activity-related discomfort or reversible knee-joint discomfort during or immediately after physical activity over a period of at least 2 months.
• Who experience pain intensity of 5 (out of 10 on the 11 point-NRS) during the stress joint test (SLSD) and perform at least 25 repetitions.
• Who have no trouble swallowing capsules
• Having a smartphone allowing using the e-PRO App NursTrial®.
• Affiliated to a French Health insurance scheme.
• Signed informed consent.

You may not qualify if:

• With diagnosed injury/trauma or tendinopathy (wiper syndrome, patellofemoral syndrome, meniscopathy), algodystrophy, osteoarthritis, rheumatic arthritis or inflammation, or other knee or joint disease.
• Extreme pain symptoms that required high-dose analgesic therapy over a longer period (\>2 weeks) or intra-articular injection treatment.
• Untreated or unstable hypothyroidism, or evidence of any neurological disorders.
• Known hypersensitivity to one of the components of the experimental products (i.e., dog rose).
• Intra-articular injections or infiltrations with hyaluronic acid, plasma-rich platelet, glucosamine, chondroitin, or supplementation, with glucosamine, chondroitin, collagen-based products in the last 3 months, or spa therapy related to join health in the last 6 months.
• Current intake of corrective treatment, plant-based products or dietary supplements that could interfere with joint, tendon or bone metabolism.
• May not be compliant or may not respect the constraints imposed by the protocol (i.e., stable physical activities and dietary habits throughout the study).
• For woman of childbearing age (neither menopausal, nor hysterectomised, nor sterilized): not using effective contraception (oral contraceptives, intra-uterine device, contraceptive implant, or condoms).

Sponsors & Collaborators

• Symrise Group: lead
• CEN Biotech: collaborator

Study Sites (1)

Cen Experimental

Dijon, 21000, France

Location

Study Officials

• Christine JUHEL, Ph.D

  CEN Biotech

  STUDY CHAIR

• Carole PERRIN, MD

  CEN Biotech

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-blind, randomized, placebo-controlled, single-center study with stratification by gender (\~40% men, \~60% women) and menopausal status for women (\~50% non-menopausal women, \~50% menopausal women). An ancillary subgroup with extended duration of supplementation.

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: December 4, 2024
• Study Start: November 25, 2024
• Primary Completion: May 9, 2025
• Study Completion: May 9, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)