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| Name | Class |
|---|---|
| CEN Biotech | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chondractiv Move | Experimental | 8-week supplementation (12 weeks in ancillary subgroup) with 4 capsules/day |
|
| Placebo | Placebo Comparator | 8-week supplementation (12 weeks in ancillary subgroup) with 4 capsules/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of activity-related joint discomfort at 4 weeks. | The pain-related activity is assessed by 0-10 Visual Analogic Scale (VAS) during SLSD (Single-Leg-Step-Down) test. | Baseline (Day 0), 4 weeks (Day 28) |
| Change from baseline of activity-related joint discomfort at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of experience of joint pain at 2 weeks | Pain is measured using the Intermittent and Constant Osteoarthritis Pain (ICOAP) questionnaire, that consists of 11 items divided into two domains: a 5-item scale for constant pain and a 6-item scale for intermittent pain. ICOAP is a self-assessed questionnaire. | Baseline (Day 0), 2 weeks (Day 14) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine JUHEL, Ph.D | CEN Biotech | Study Chair |
| Carole PERRIN, MD | CEN Biotech | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cen Experimental | Dijon | 21000 | France |
Subjects data is not anonymized. To comply with European regulations and national provisions, subjects are informed that no sharing of IPD is planned in order to protect their personal data. If data is to be shared, patients must be informed individually, and their consent obtained.
At this stage, only aggregated data can be shared
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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.
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| Placebo | Other | Placebo contains 100% maltodextrins as non-active agent at the dose of 1800 mg/day. |
|
The pain-related activity is assessed by 0-10 Visual Analogic Scale (VAS) during SLSD (Single-Leg-Step-Down) test.This outcome is only measured in ancillary group. |
| Baseline (Day 0), 4 weeks (Day 84) |
| Activity-related pain at regular exercise/physical activity | Average weekly pain intensity at exercise measured using 0-100 VAS (0 meaning no pain, 100 worst possible pain). At each training session or competition, the subject rates the intensity of pain perceived at exercise. | Baseline (Day 0), 4 weeks (Day 84) |
| Change from baseline on overall physical function at 2 weeks | Overall physical function is measured using the Knee injury and Osteoarthritis Outcome Score (KOOS), that consists of 42 items assessing 5 dimensions: pain, other symptoms, activities of daily living, function in sport/recreation, knee related Quality of Life (QoL). KOOS is a self-assessed questionnaire. | Baseline (Day 0), 2 weeks (Day 14) |
| Change from baseline on overall physical function at 4 weeks | Overall physical function is measured using the Knee injury and Osteoarthritis Outcome Score (KOOS), that consists of 42 items assessing 5 dimensions: pain, other symptoms, activities of daily living, function in sport/recreation, knee related Quality of Life (QoL). KOOS is a self-assessed questionnaire. | Baseline (Day 0), 4 weeks (Day 28) |
| Change from baseline on overall physical function at 6 weeks | Overall physical function is measured using the Knee injury and Osteoarthritis Outcome Score (KOOS), that consists of 42 items assessing 5 dimensions: pain, other symptoms, activities of daily living, function in sport/recreation, knee related Quality of Life (QoL). KOOS is a self-assessed questionnaire. | Baseline (Day 0), 6 weeks (Day 42) |
| Change from baseline on overall physical function at 8 weeks | Overall physical function is measured using the Knee injury and Osteoarthritis Outcome Score (KOOS), that consists of 42 items assessing 5 dimensions: pain, other symptoms, activities of daily living, function in sport/recreation, knee related Quality of Life (QoL). KOOS is a self-assessed questionnaire. | Baseline (Day 0), 8 weeks (Day 56) |
| Change from baseline on overall physical function at 10 weeks | Overall physical function is measured using the Knee injury and Osteoarthritis Outcome Score (KOOS), that consists of 42 items assessing 5 dimensions: pain, other symptoms, activities of daily living, function in sport/recreation, knee related Quality of Life (QoL). KOOS is a self-assessed questionnaire. At week 10, outcome is only measured in ancillary subgroup. | Baseline (Day 0), 10 weeks (Day 70) |
| Change from baseline on overall physical function at 12 weeks | Overall physical function is measured using the Knee injury and Osteoarthritis Outcome Score (KOOS), that consists of 42 items assessing 5 dimensions: pain, other symptoms, activities of daily living, function in sport/recreation, knee related Quality of Life (QoL). KOOS is a self-assessed questionnaire. At week 12, outcome is only measured in ancillary subgroup. | Baseline (Day 0), 12 weeks (Day 84) |
| Change from baseline of knee mobility at 4 weeks | Flexion and extension degrees of the knee measured using the Knee Range of Motion (ROM). Measures is carried out by the investigator using a goniometer. | Baseline (Day 0), 4 weeks (Day 28) |
| Change from baseline of knee mobility at 8 weeks | Flexion and extension degrees of the knee measured using the Knee Range of Motion (ROM). Measures is carried out by the investigator using a goniometer. | Baseline (Day 0), 8 weeks (D56) |
| Change from baseline of knee mobility at 12 weeks | Flexion and extension degrees of the knee measured using the Knee Range of Motion (ROM). Measures is carried out by the investigator using a goniometer. At week 12, outcome is only measured in ancillary subgroup. | Baseline (Day 0), 12 weeks (Day 84) |
| Change from baseline of quality of life at 4 weeks | Quality of life measured using the SF-12, that consists of 12 item-short form of the generic Health-related Quality of Life SF-36. The questionnaire is a self-assessment. | Baseline (Day 0), 4 weeks (Day 28) |
| Change from baseline of quality of life at 8 weeks | Quality of life measured using the SF-12, that consists of 12 item-short form of the generic Health-related Quality of Life SF-36. The questionnaire is a self-assessment. | Baseline (Day 0), 8 weeks (Day 56) |
| Change from baseline of quality of life at 12 weeks | Quality of life measured using the SF-12, that consists of 12 item-short form of the generic Health-related Quality of Life SF-36. The questionnaire is a self-assessment. At week 12, outcome is only measured in ancillary subgroup. | Baseline (Day 0), 12 weeks (Day 84) |
| Satisfaction with the supplementation | Satisfaction is assessed using a questionnaire with 5-point Likert scale ((1) Strongly disagree; (2) Disagree; (3) Neither agree nor disagree; (4) Agree; (5) Strongly agree)) or 4-point Likert scale ((1) Entirely satisfied; (2) Satisfied; (3) Not satisfied; (4) Not satisfied at all), to questions related to the perceived effectiveness. | 8 weeks (Day 56) or 12 weeks (D84) for ancillary group |
| Change from baseline of experience of joint pain at 4 weeks | Pain is measured using the Intermittent and Constant Osteoarthritis Pain (ICOAP) questionnaire, that consists of 11 items divided into two domains: a 5-item scale for constant pain and a 6-item scale for intermittent pain. ICOAP is a self-assessed questionnaire. | Baseline (Day 0), 4 weeks (Day 28) |
| Change from baseline of experience of joint pain at 6 weeks | Pain is measured using the Intermittent and Constant Osteoarthritis Pain (ICOAP) questionnaire, that consists of 11 items divided into two domains: a 5-item scale for constant pain and a 6-item scale for intermittent pain. ICOAP is a self-assessed questionnaire. | Baseline (Day 0), 6 weeks (Day 42) |
| Change from baseline of experience of joint pain at 8 weeks | Pain is measured using the Intermittent and Constant Osteoarthritis Pain (ICOAP) questionnaire, that consists of 11 items divided into two domains: a 5-item scale for constant pain and a 6-item scale for intermittent pain. ICOAP is a self-assessed questionnaire. | Baseline (Day 0), 8 weeks (Day 56) |
| Change from baseline of experience of joint pain at 10 weeks | Pain is measured using the Intermittent and Constant Osteoarthritis Pain (ICOAP) questionnaire, that consists of 11 items divided into two domains: a 5-item scale for constant pain and a 6-item scale for intermittent pain. ICOAP is a self-assessed questionnaire. At week 10, outcome is only measured in ancillary subgroup. | Baseline (Day 0), 10 weeks (Day 70)] |
| Change from baseline of experience of joint pain at 12 weeks | Pain is measured using the Intermittent and Constant Osteoarthritis Pain (ICOAP) questionnaire, that consists of 11 items divided into two domains: a 5-item scale for constant pain and a 6-item scale for intermittent pain. ICOAP is a self-assessed questionnaire. At week 12, outcome is only measured in ancillary subgroup. | Baseline (Day 0), 12 weeks (Day 84) |
| Change from baseline in cartilage synthesis at 8 weeks | Serum concentrations of Type IIA collagen N-propeptide are measured using ELISA assays. | Baseline (Day 0), 8 weeks (Day 56) |
| Change from baseline in cartilage degradation at 8 weeks | Serum concentrations of Cartilage oligomeric matrix protein (COMP) are measured using ELISA assays. | Baseline (Day 0), 8 weeks (Day 56)] |
| Impression improvement of joint function/discomfort at 2 weeks | Subjective impression of improvement is self-assessed by the subject using a 5-point Likert scale: ((1) Strongly disagree; (2) Disagree; (3) Neither agree nor disagree; (4) Agree; (5) Strongly agree)) in response to "Since I started the supplementation, I am feeling an improvement: of my knee mobility/ knee stiffness/ joint comfort during physical activity/ joint comfort during daily activities". | Baseline (Day 0), 2 weeks (Day 14) |
| Impression improvement of joint function/discomfort at 4 weeks | Subjective impression of improvement is self-assessed by the subject using a 5-point Likert scale: ((1) Strongly disagree; (2) Disagree; (3) Neither agree nor disagree; (4) Agree; (5) Strongly agree)) in response to "Since I started the supplementation, I am feeling an improvement: of my knee mobility/ knee stiffness/ joint comfort during physical activity/ joint comfort during daily activities". | Baseline (Day 0), 4 weeks (Day 28) |
| Impression improvement of joint function/discomfort at 6 weeks | Subjective impression of improvement is self-assessed by the subject using a 5-point Likert scale: ((1) Strongly disagree; (2) Disagree; (3) Neither agree nor disagree; (4) Agree; (5) Strongly agree)) in response to "Since I started the supplementation, I am feeling an improvement: of my knee mobility/ knee stiffness/ joint comfort during physical activity/ joint comfort during daily activities". | Baseline (Day 0), 6 weeks (Day 42) |
| Impression improvement of joint function/discomfort at 8 weeks | Subjective impression of improvement is self-assessed by the subject using a 5-point Likert scale: ((1) Strongly disagree; (2) Disagree; (3) Neither agree nor disagree; (4) Agree; (5) Strongly agree)) in response to "Since I started the supplementation, I am feeling an improvement: of my knee mobility/ knee stiffness/ joint comfort during physical activity/ joint comfort during daily activities". | Baseline (Day 0), 8 weeks (Day 56) |
| Impression improvement of joint function/discomfort at 10 weeks | Subjective impression of improvement is self-assessed by the subject using a 5-point Likert scale: ((1) Strongly disagree; (2) Disagree; (3) Neither agree nor disagree; (4) Agree; (5) Strongly agree)) in response to "Since I started the supplementation, I am feeling an improvement: of my knee mobility/ knee stiffness/ joint comfort during physical activity/ joint comfort during daily activities". At week 10, outcome is only measured in ancillary subgroup. | Baseline (Day 0), 10 weeks (Day 70) |
| Impression improvement of joint function/discomfort at 12 weeks | Subjective impression of improvement is self-assessed by the subject using a 5-point Likert scale: ((1) Strongly disagree; (2) Disagree; (3) Neither agree nor disagree; (4) Agree; (5) Strongly agree)) in response to "Since I started the supplementation, I am feeling an improvement: of my knee mobility/ knee stiffness/ joint comfort during physical activity/ joint comfort during daily activities". At week 12, outcome is only measured in ancillary subgroup. | Baseline (Day 0), 12 weeks (Day 84) |
| Evaluation of therapeutic saving | Consumption of anti-inflammatory and analgesic drugs taken to relieve knee pain (name, number, dose) and recorded by the subject from Day 0 to Day 56, and Day 0 to Day 84 in ancillary subgroup. Drug consumption is expressed as equivalent doses of ibuprofen or paracetamol. | 8 weeks (Day 56) or 12 weeks (Day 84) in ancillary subgroup |
| Adverse effect | Adverse events are described using the MedDRA dictionary. Adverse event with possible relation to the experimental products are classified by type of adverse reaction. | 8 weeks (Day 56) or 12 weeks (Day 84) in ancillary subgroup |