Clinical trial NCT06714851: Chondractiv Move on Activity-related Joint Discomfort
Official title: Effect of Chondractiv Move (Dietary Supplement) on Activity-related Joint Discomfort in Physically Active Subjects: a Double-blind, Randomized, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Joint; Derangement
Keywords: Activity-related joint discomfort
Collagen hydrolysate
Lead sponsor: Symrise Group
Sponsor class: INDUSTRY
Collaborators: name: CEN Biotech
First posted: 2024-12-04
Enrollment: 144
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: BASIC_SCIENCE

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.

Detailed description: This study requires the inclusion of about 140 participants who regularly take part in sporting activities and report knee pain during and/or after this activity.

Participants are randomly assigned to the control group receiving a placebo (a neutral product based on maltodextrins with no effect), or to the test group receiving the dietary supplement. This study is a double-blind, randomized controlled trial. This means that participants as well as assessors do not know the allocation group. This is a necessary procedure to guarantee impartiality in clinical trials.

Participants ingest placebo or dietary supplement for 8 consecutive weeks (or 12 weeks in the ancillary group with extended supplementation duration).

To assess the effect of supplementation, participants are asked to attend medical check-ups and complete questionnaires, before starting the treatment to determine basal values, and then at regular intervals, i.e. every 2 weeks or every month.

Throughout their participation, participants are monitored by the study doctor and must go to a clinical investigation center for doctors visits.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).
* Enrolled in another clinical trial or being in a period of exclusion from a previous clinical trial.
* For woman of childbearing age (neither menopausal, nor hysterectomised, nor sterilized): not using effective contraception (oral contraceptives, intra-uterine device, contraceptive implant, or condoms).
* Belonging to a population covered by articles L.1121-5 (pregnant confirmed by urinary test at inclusion or breastfeeding women), L.1121-6 (persons deprived of their liberty by judicial or administrative decision, persons under psychiatric care), and L.1121.8 (adults under legal protection or unable to express their consent) of the CSP (French Public Health Code).

Primary outcomes:
measure: Change from baseline of activity-related joint discomfort at 8 weeks
timeFrame: Baseline (Day 0), 8 weeks (Day 56)
Secondary outcomes:
measure: Change from baseline of activity-related joint discomfort at 4 weeks.
timeFrame: Baseline (Day 0), 4 weeks (Day 28)
measure: Change from baseline of activity-related joint discomfort at 12 weeks
timeFrame: Baseline (Day 0), 4 weeks (Day 84)
measure: Activity-related pain at regular exercise/physical activity
timeFrame: Baseline (Day 0), 4 weeks (Day 84)
measure: Change from baseline on overall physical function at 2 weeks
timeFrame: Baseline (Day 0), 2 weeks (Day 14)
measure: Change from baseline on overall physical function at 4 weeks
timeFrame: Baseline (Day 0), 4 weeks (Day 28)
measure: Change from baseline on overall physical function at 6 weeks
timeFrame: Baseline (Day 0), 6 weeks (Day 42)
measure: Change from baseline on overall physical function at 8 weeks
timeFrame: Baseline (Day 0), 8 weeks (Day 56)
measure: Change from baseline on overall physical function at 10 weeks
timeFrame: Baseline (Day 0), 10 weeks (Day 70)
measure: Change from baseline on overall physical function at 12 weeks
timeFrame: Baseline (Day 0), 12 weeks (Day 84)
measure: Change from baseline of knee mobility at 4 weeks
timeFrame: Baseline (Day 0), 4 weeks (Day 28)
measure: Change from baseline of knee mobility at 8 weeks
timeFrame: Baseline (Day 0), 8 weeks (D56)
measure: Change from baseline of knee mobility at 12 weeks
timeFrame: Baseline (Day 0), 12 weeks (Day 84)
measure: Change from baseline of quality of life at 4 weeks
timeFrame: Baseline (Day 0), 4 weeks (Day 28)
measure: Change from baseline of quality of life at 8 weeks
timeFrame: Baseline (Day 0), 8 weeks (Day 56)
measure: Change from baseline of quality of life at 12 weeks
timeFrame: Baseline (Day 0), 12 weeks (Day 84)
measure: Satisfaction with the supplementation
timeFrame: 8 weeks (Day 56) or 12 weeks (D84) for ancillary group
Other outcomes:
measure: Change from baseline of experience of joint pain at 2 weeks
timeFrame: Baseline (Day 0), 2 weeks (Day 14)
measure: Change from baseline of experience of joint pain at 4 weeks
timeFrame: Baseline (Day 0), 4 weeks (Day 28)
measure: Change from baseline of experience of joint pain at 6 weeks
timeFrame: Baseline (Day 0), 6 weeks (Day 42)
measure: Change from baseline of experience of joint pain at 8 weeks
timeFrame: Baseline (Day 0), 8 weeks (Day 56)
measure: Change from baseline of experience of joint pain at 10 weeks
timeFrame: Baseline (Day 0), 10 weeks (Day 70)]
measure: Change from baseline of experience of joint pain at 12 weeks
timeFrame: Baseline (Day 0), 12 weeks (Day 84)
measure: Change from baseline in cartilage synthesis at 8 weeks
timeFrame: Baseline (Day 0), 8 weeks (Day 56)
measure: Change from baseline in cartilage degradation at 8 weeks
timeFrame: Baseline (Day 0), 8 weeks (Day 56)]
measure: Impression improvement of joint function/discomfort at 2 weeks
timeFrame: Baseline (Day 0), 2 weeks (Day 14)
measure: Impression improvement of joint function/discomfort at 4 weeks
timeFrame: Baseline (Day 0), 4 weeks (Day 28)
measure: Impression improvement of joint function/discomfort at 6 weeks
timeFrame: Baseline (Day 0), 6 weeks (Day 42)
measure: Impression improvement of joint function/discomfort at 8 weeks
timeFrame: Baseline (Day 0), 8 weeks (Day 56)
measure: Impression improvement of joint function/discomfort at 10 weeks
timeFrame: Baseline (Day 0), 10 weeks (Day 70)
measure: Impression improvement of joint function/discomfort at 12 weeks
timeFrame: Baseline (Day 0), 12 weeks (Day 84)
measure: Evaluation of therapeutic saving
timeFrame: 8 weeks (Day 56) or 12 weeks (Day 84) in ancillary subgroup
measure: Adverse effect
timeFrame: 8 weeks (Day 56) or 12 weeks (Day 84) in ancillary subgroup
Locations:
city: Dijon
country: France
facility: Cen Experimental
Study officials:
affiliation: CEN Biotech
name: Christine JUHEL, Ph.D
role: STUDY_CHAIR
affiliation: CEN Biotech
name: Carole PERRIN, MD
role: PRINCIPAL_INVESTIGATOR
References: