Actively Recruiting
Evaluation of the Effect of Agar and/or Collagen Based Compounds on Osteoarticular Pain A Randomized, Parallel, Placebo Controlled, Triple Blind Clinical Trial
Led by Fundació Eurecat · Updated on 2026-01-06
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
F
Fundació Eurecat
Lead Sponsor
H
HISPANAGAR SA
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the effects of agar-agar, undenatured type II collagen (UC-II), and their combination on knee joint pain in adults aged 40 to 70 with mild to moderate joint pain but without an osteoarthritis diagnosis. This study aims to assess improvements in pain, stiffness, functional capacity, and overall knee health using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The trial is randomized, placebo-controlled, triple-blind, and parallel-group in design, involving 80 participants. Participants are randomly assigned to one of four groups to receive daily capsules for 12 weeks: agar-agar alone, agar-agar combined with UC-II, UC-II alone, or placebo. Each supplement and placebo is given in capsule form with precise dosing: 2.4 g of agar-agar, 40 mg of UC-II plus 2.4 g maltodextrin for the UC-II group, or 2.4 g maltodextrin for placebo. The study includes a pre-screening visit, a baseline visit to start treatment, a mid-study telephone follow-up, and an end-of-study visit. The total participation duration is 13 weeks. During the study, participants will undergo assessments of knee pain, stiffness, functional capacity, and range of motion at baseline, 6 weeks, and 12 weeks. Additional evaluations include hand joint assessments, medication use, inflammatory and collagen metabolism blood markers, body composition, dietary intake, physical activity, safety monitoring, and treatment adherence. The primary outcome is the change in knee joint pain perception measured by the WOMAC Pain subscale throughout the treatment period.
CONDITIONS
Brief Title
Effect of Agar/Collagen-based Compounds on Osteoarticular Pain: Randomized Triple-blind Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women between 40 and 70 years of age.
- Score 6 to 10 out of 20 on the WOMAC knee pain questionnaire.
- Sign the informed consent form.
- Able to read, write, and speak Spanish and/or Catalan.
You will not qualify if you...
- Body mass index (BMI) less than 18.5 or 30 kg/m² or higher.
- Allergies or intolerances to agar-agar, collagen, maltodextrin, or study product components.
- Use of medications affecting study results, including recent corticosteroid treatment or osteoarthritis drugs.
- Dependence on prescription pain medications.
- Use of multivitamins, collagen derivatives, or anti-inflammatory supplements unless discontinued at least two weeks before and during the study.
- Active smokers or those who quit less than 6 months ago.
- Excessive alcohol consumption (men: 4 or more standard drinks daily or weekly; women: 2 or more daily or weekly).
- Diagnosis of osteoarthritis, rheumatoid arthritis, other inflammatory arthritis, gout, knee infection, recent joint injury or surgery.
- Gastrointestinal diseases affecting absorption, active cancer in digestive or renal organs, or hepatitis.
- Significant weight loss of 3 kg or more in the last 3 months.
- Pregnancy, breastfeeding, or intention to become pregnant.
- Unable to follow study guidelines.
- Participation in another clinical trial involving drug or nutritional intervention within 30 days prior to inclusion.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment
Duration - 12 weeks
Participants take their assigned supplement once daily for 12 weeks to evaluate its effect on knee joint pain and other health measures.
1 baseline visit (in-person), 1 mid-study telephone follow-up, and 1 end-of-study visit (in-person)
Trial Site Locations
Total: 1 location
1
Eurecat, Technological Center of Catalonia, Nutrition and Health Unit
Reus, Tarragona, Spain, 43204
Actively Recruiting
Research Team
A
Antoni Caimari Palou, PhD
A
Anna Crescenti, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here