Evaluation of the Effect of Agar and/or Collagen Based Compounds on Osteoarticular Pain. A Randomized, Parallel, Placebo Controlled, Triple Blind Clinical Trial (AGARTROSIS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in perception of knee joint pain.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Present body mass index (BMI) values <18.5 kg/m^2 or ≥30 kg/m^
- •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.
- •Take multivitamin or mineral supplements, collagen derivatives, or supplements containing bioactive compounds that may exert an anti-inflammatory effect, such as turmeric, ginger, omega-3, or polyphenol supplements.
- •(Individuals who consume multivitamin, mineral, or collagen-derived supplements or supplements will be eligible to participate in the study, provided they are willing to discontinue their intake for at least two weeks prior to the start of the study and throughout the entire study period).
- •Be an active smoker or have been one for less than 6 months.
- •Alcohol consumption:
- •Men: Consume 4 or more Standard Drink Units (SDU) daily or SDUs weekly.
- •Women: Consume 2 or more Standard Drink Units (SDU)* daily or SDUs weekly.
- •Have a diagnosis of osteoarthritis, active rheumatoid arthritis, and any inflammatory arthritic condition such as secondary inflammatory arthritis, gout, pseudogout, knee infection, marked angular deformities, or significant injury to the target joint within the 6 months prior to the start of the trial; arthroplasty and joint surgery of the target knee within the 2 years prior to the start of the study.
- •Have any gastrointestinal disease that affects the absorption of the compound and/or the study results, such as celiac disease, Crohn's disease, active cancer of any organ of the digestive or renal system, or hepatitis.
- •Be ineligible to participate in the study, according to the pre-screening evaluator's criteria.
- •Have lost 3 kg or more in the last 3 months.
- •Be pregnant or intend to become pregnant.
- •Be breastfeeding.
- •Be unable to follow the study guidelines.
- •Be participating or have participated in a clinical trial involving drug intervention or nutritional intervention within the last 30 days prior to inclusion in the study.
结局指标
主要结局
Change in perception of knee joint pain.
时间窗: Before (baseline), during (6 weeks) and after treatment period (12 weeks).
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).
次要结局
- Body weight.(at week 1.)
- Height.(At week 1.)
- Changes in the amount of total body water.(Before (baseline) and after treatment period (12 weeks).)
- Body mass index (BMI) (kg/m^2).(At week1.)
- Age.(At week 1.)
- Changes in body weight.(Before (baseline) and after treatment period (12 weeks).)
- Changes in the amount of bone mass.(Before (baseline) and after treatment period (12 weeks).)
- Changes in systolic and diastolic blood pressure and resting heart rate.(Before (baseline) and after treatment period (12 weeks).)
- Change in BMI.(Before (baseline) and after treatment period (12 weeks).)
- Change in the amount of lean mass.(Before (baseline) and after treatment period (12 weeks).)
- Changes in bone mineral content.(Before (baseline) and after treatment period (12 weeks).)
- Changes in segmental phase angle.(Before (baseline) and after treatment period (12 weeks).)
- Changes in segmental impedance.(Before (baseline) and after treatment period (12 weeks).)
- Change in perception of knee joint stiffness.(Before (baseline) during ( 6 weeks) and after treatment period (12 weeks).)
- Change in perception of knee functional capacity.(Before (baseline) during ( 6 weeks) and after treatment period (12 weeks).)
- Changes in the functional capacity of the hand joints(Before (baseline), and after treatment period (12 weeks))
- Changes in the perception of the general health status of the knee(Before (baseline) during ( 6 weeks) and after treatment period (12 weeks).)
- Perception of pain in the hand joint(Before (baseline) during ( 6 weeks) and after treatment period (12 weeks).)
- Changes in perception of hand joint stiffness(Before (baseline) during ( 6 weeks) and after treatment period (12 weeks).)
- Changes in perception of the functional capacity of the hand joint(Before (baseline) during ( 6 weeks) and after treatment period (12 weeks).)
- Changes in knee range of motion(Before (baseline) and after treatment period (12 weeks).)
- Changes in plasma interleukin 6 (IL-6) concentration.(Before (baseline) and after treatment period (12 weeks).)
- Changes in the speed when going up and down stairs.(Before (baseline) and after treatment period (12 weeks).)
- Changes in serum High-sensitivity C-reactive protein (hsCRP) concentration.(Before (baseline) and after treatment period (12 weeks).)
- Changes in pain perception at the end of the Stair Climb Test(Before (baseline) and after treatment period (12 weeks).)
- Changes in plasma monocyte chemotactic protein 1 (MCP-1) concentration(Before (baseline) and after treatment period (12 weeks).)
- Changes in plasma tumor necrosis alpha (TNF-a) concentration.(Before (baseline) and after treatment period (12 weeks).)
- Changes in serum levels of C-terminal telopeptide of type 1 collagen (CTX1).(Before (baseline) and after treatment period (12 weeks).)
- Changes in serum levels of N-terminal propeptide of type I collagen (PINP).(Before (baseline) and after treatment period (12 weeks).)
- Changes in serum levels of hyaluronic acid (HA).(Before (baseline) and after treatment period (12 weeks).)
- Changes in serum levels of cartilage oligomeric matrix protein (COMP).(Before (baseline) and after treatment period (12 weeks).)
- Changes in concomitant medications.(Before (baseline), during (6 week) and after treatment period (12 weeks).)
- Changes in pain-relieving medication use.(Before (baseline), during (6 week) and after treatment period (12 weeks).)
- Dietary control.(Before (baseline), during (6 week) and after treatment period (12 weeks).)
- Changes in dietary supplement use.(Before (baseline), during (6 week) and after treatment period (12 weeks).)
- Physical activity levels.(Before (baseline), and after treatment period (12 weeks).)
- Monitoring of adverse effects.(During (6 week) and after treatment period (12 weeks).)
- Treatment adherence rate.(During (6 week) and after treatment period (12 weeks).)
- Changes in the amount of body fat.(Before (baseline) and after treatment period (12 weeks).)
- Changes in the amount of muscle mass.(Before (baseline) and after treatment period (12 weeks).)