Effect of Agar/Collagen-based Compounds on Osteoarticular Pain: Randomized Triple-blind Clinical Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-70
SponsorFundació Eurecat

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Agar-Agar

    Dietary supplement

    2.4 g of agar-agar (Rhodophyceae group) presented in capsule form will be given.

  • Agar-Agar and undenatured collagen type II

    Dietary supplement

    2.4 g of agar- agar + 40 mg of undenatured collagen type II, presented in capsule form will be given.

  • undenatured collagen type II

    Dietary supplement

    40 mg of undenatured collagen type II + 2.4 g of maltodextrin will be given in capsule form

  • Placebo

    Dietary supplement

    2.4 g Maltodextrin will be given in capsule form

Treatment groups

80 Participants
are divided into 4 treatment groups
Group A: Agar-Agar (A-A)Experimental treatment 1 intervention
Group B: Agar-Agar + undenatured collagen type II (A+UC-II)Experimental treatment 1 intervention
Group C: undenatured collagen type II (UC-II)Active comparator 1 intervention
Group D: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
Before (baseline), during (6 weeks) and after treatment period (12 weeks).

Secondary outcomes

1

Body weight.

Body weight will be measured by Tanita TBF-300 (Body Composition Analyzer, Brooklyn NY, USA) as a descriptive variable.

Time frame
at week 1.
2

Height.

Height will be measured by standardized method.

Time frame
At week 1.
3

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.

Time frame
At week1.
4

Age.

Age will be recorded in years.

Time frame
At week 1.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fundació Eurecat

Lead sponsor

HISPANAGAR SA

Collaborator