About this trial
Joints-comprising bone, cartilage, ligaments, and synovial fluid-enable stable daily movement but may deteriorate with age, excess body weight, overuse, injury, or disease. Such degeneration, common from age 40 onward, underlies joint disorders like osteoarthritis, particularly in the knees, hips, hands, and spine, and is a major cause of chronic pain and disability. While antiinflammatory analgesics remain the standard approach to symptom control, they neither cure disease nor regenerate cartilage and can produce significant long-term adverse effects (gastrointestinal, hepatic, renal, and cardiovascular). These limitations motivate interest in natural or complementary strategies with safer profiles.
Within this context, marine algae, especially agar derived from red seaweed, have attracted attention for potential intestinal, metabolic, and joint benefits, aided by their fiber content. Another promising option is undenatured type II collagen (UC-II), the principal structural component of articular cartilage, whose endogenous production declines with age; clinical studies indicate that a daily intake of 40 mg UC-II can improve mobility, reduce pain, and enhance quality of life in individuals with osteoarthritis or exercise-related joint discomfort. Based on these considerations, an agar-agar supplement has been developed to relieve knee joint symptoms.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men and women between 40 and 70 years of age.
Submit a score of 6 to 10 out of 20 on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) knee pain questionnaire.
Sign the informed consent form.
Know how to read, write, and speak Spanish and/or Catalan.
Disqualifiers
Present body mass index (BMI) values <18.5 kg/m² or ≥30 kg/m².
Present intolerances or allergies related to Agar-Agar, or any of the components of the products being evaluated, such as collagen or maltodextrin.
Take or have taken medications that may affect the study results. This is especially true for those who have been treated with oral or intra-articular corticosteroids within the 4 and 12 weeks prior to screening, respectively, or medications for osteoarthritis at the time of screening.
Patients who depend on prescription medications for pain control.
Trial design
Parallel
Treatments tested in this trial
Agar-Agar
Dietary supplement2.4 g of agar-agar (Rhodophyceae group) presented in capsule form will be given.
Agar-Agar and undenatured collagen type II
Dietary supplement2.4 g of agar- agar + 40 mg of undenatured collagen type II, presented in capsule form will be given.
undenatured collagen type II
Dietary supplement40 mg of undenatured collagen type II + 2.4 g of maltodextrin will be given in capsule form
Placebo
Dietary supplement2.4 g Maltodextrin will be given in capsule form
Treatment groups
Trial outcomes
Primary outcomes
Change in perception of knee joint pain.
This will be determined using the pain subscale of the Western Ontario and McMaster Universities Osteoarthritis Index questionnaire. The questionnaire assesses clinically meaningful changes in symptoms and physical disability in individuals with osteoarthritis or those experiencing joint discomfort. It evaluates the perceived intensity of knee pain using the Likert scale (0: no pain; 1: mild pain; 2: moderate pain; 3: severe pain; 4: extreme pain).
Secondary outcomes
Body weight.
Body weight will be measured by Tanita TBF-300 (Body Composition Analyzer, Brooklyn NY, USA) as a descriptive variable.
Height.
Height will be measured by standardized method.
Body mass index (BMI) (kg/m^2).
BMI will be determined using the Tanita TBF-300 (Body Composition Analyzer, Brooklyn, NY, USA) as a descriptive variable.
Age.
Age will be recorded in years.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Fundació Eurecat
Lead sponsor
HISPANAGAR SA
Collaborator