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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-10

Study Completion Date

2027-02-28

Brief Summary

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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.

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Detailed Description

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The primary objective of this study was to evaluate the effect of agar-agar (A-A), the combination of A-A with undenatured type II collagen (A+UC-II), and undenatured type II collagen (UC-II) on knee joint pain, assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), in subjects with mild to moderate joint pain without a diagnosis of osteoarthritis, compared with a control compound.

The secondary objectives were to evaluate the effects of A-A, A+UC-II, and UC-II consumption on:

* Knee joint stiffness and functional capacity (subjective assessment).
* Overall perception of knee health (subjective assessment).
* Pain, stiffness, and functional capacity of the hand (subjective assessment).
* Range of motion of the knee.
* Functional capacity of the knee (objective assessment).
* Functional capacity of the hand (objective assessment).
* Frequency of medication use for joint pain relief (anti-inflammatories, analgesics).
* Inflammatory blood markers.
* Blood markers of collagen and bone metabolism.
* Body composition.

The primary endpoint is patient-reported knee joint pain, assessed using the Pain subscale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire.

This is a randomized, placebo-controlled, triple-blind, parallel-group nutritional intervention with an allocation ratio of 1:1:1:1. A total of 80 participants (men and women) will be enrolled. Following a pre-screening visit to verify inclusion and exclusion criteria, eligible participants will be randomly assigned to one of four groups (n=20 per group) to consume, once daily for 12 weeks, one of the following products: agar-agar (A-A), A-A+UC-II (A+UC-II), UC-II alone, or placebo.

Each participant will complete three in-person visits and one interim telephone follow-up: a pre-screening visit (eligibility assessment), a baseline visit to initiate the intervention, a mid-study telephone follow-up, and an end-of-study visit. The total duration per participant will be 13 weeks.

The primary endpoint is patient-reported knee joint pain, assessed using the Pain subscale of the WOMAC questionnaire.

Conditions

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Osteearthritis Joint Damage Inflammation Cartilage Damage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, parallel, placebo-controlled, triple-blind nutritional intervention clinical study, with a 1:1:1:1 ratio between interventions.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Agar-Agar (A-A)

Participants assigned to this group will receive agar-agar (A-A) supplementation and will take it for 12 weeks.

Group Type EXPERIMENTAL