NCT07729657尚未招募不适用
Verification Study of the Effects of Consumption of the Test Food on the Musculoskeletal System: a Randomized, Placebo-controlled, Double-blind, Parallel-group Comparison Study
Bloomage Biotechnology Corp., Ltd.2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2026年9月9日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Knee pain intensity evaluated by Visual Analogue Scale (VAS)
研究概览
简要总结
The goal of this clinical trial is to test the effects of the test products on the locomotor system in healthy Japanese adults with low muscle mass and knee joint discomfort. The main question it aims to answer is:
• Does the daily consumption of the test product improve subjective knee symptoms, quality of life (QOL), and physical function?
Participants will be asked to:
- Take 3 capsules of the test product daily for 12 weeks.
- Complete questionnaires regarding subjective knee symptoms and QOL.
- Undergo bilateral X-ray imaging.
- Undergo assessment of lower limb extension strength.
- Perform the stand-up test to evaluate lower limb muscle endurance.
- Perform the 10-meter walk test to evaluate walking ability.
- Undergo anthropometric and physical measurements. Researchers will compare Test Product 1, Test Product 2, and Test Product 3, against a placebo group to see if consumption of the study products improves knee symptoms, QOL, and physical function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women
- •Healthy individuals
- •Individuals whose body mass index is ≥18.5 and <30 kg/m2
- •Individuals who have low whole-body muscle mass
- •Individuals with KL grades of 0 or I on radiographic examination
- •Individuals with high knee pain intensity using the JKOM, as measured by VAS
排除标准
- •Individuals receiving treatment for or have a history of malignant tumors, heart failure, or myocardial infarction
- •Individuals with an implanted pacemaker or implantable cardioverter-defibrillator
- •Individuals undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
- •Individuals consuming Foods for Specified Health Uses (FOSHU) or FFC
- •Individuals taking or using medications (including herbal medicines) or supplements
- •Individuals who are allergic to medications or foods related to the test product
- •Individuals engaging at least 60 minutes per week in physical activity that induces heavy breathing and sweating
- •Individuals engaging in strength training (including bodyweight exercises such as push-ups), running, walking, cycling, or swimming at least twice a week
- •Individuals who are pregnant, lactating, or planning to become pregnant during the study period
- •Individuals usually taking FOSHU or FFC, e.g., NAG, proteoglycan from salmon nasal cartilage (SNC), undenatured type II collagen from SNC, glucosamine hydrochloride, curcumin, elastin peptide from skipjack, or collagen peptide
- •Individuals engaging in intense knee joint-loading exercise (e.g., ball sports, such as soccer, baseball, and basketball, jogging, running, skiing, or snowboarding)
- •Individuals who use a cane or joint support, or may use them during this study
- •Individuals deemed unsuitable to participate in this study by the principal investigator
研究组 & 干预措施
NAG + HA group
Active Comparator
Participants in this arm will consume the active study product containing NAG and HA.
干预措施: Food containing NAG and HA (Dietary Supplement)
NAG group
Active Comparator
Participants in this arm will consume the active study product containing NAG.
干预措施: Food containing NAG (Dietary Supplement)
Placebo group
Placebo Comparator
Participants in this arm will consume a placebo product visually and organoleptically identical to the active products but without the active ingredients.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Knee pain intensity evaluated by Visual Analogue Scale (VAS)
时间窗: Baseline and Week 12
Knee pain intensity will be assessed using the VAS component of the Japanese Knee Osteoarthritis Measure (JKOM). The VAS scores range from 0 mm (no pain) to 100 mm (worst possible pain), with higher scores indicating greater pain intensity.
次要结局
- Total score based on the JKOM(Baseline, Week 1, and Week 12)
- Knee pain and stiffness subscale score based on the JKOM(Baseline, Week 1, and Week 12)
- Condition of daily life subscale score based on the JKOM(Baseline, Week 1, and Week 12)
- General activity subscale score based on the JKOM(Baseline, Week 1, and Week 12)
- Health conditions subscale score based on the JKOM(Baseline, Week 1, and Week 12)
- Number of participants showing an improvement of >= 1 grade in the JKOM questionnaire items(Week 1 and Week 12)
- Serum interleukin-6 (IL-6) level(Baseline and Week 12)
- Walking parameters evaluated by 10 m walk test(Baseline and Week 12)
- Lower limb muscle strength parameters evaluated by LocomoScan G(Baseline and Week 12)
- Number of stand-ups in the 30-second sit-to-stand test(Baseline and Week 12)
- Body composition parameters(Baseline and Week 12)
- Body composition parameters (body height)(Baseline)
- Body composition parameters (body mass index (BMI))(Baseline and Week 12)
- Changes from baseline in body composition parameters(Baseline and Week 12)
- Percentage changes from baseline in body composition parameters(Baseline and Week 12)
- Individuals who experienced adverse events(Intervention period)
- Individuals whose values of urinalysis and peripheral blood test are outside the reference range after intervention despite within the reference range at baseline(Baseline and Week 12)
- Systolic and diastolic blood pressure(Baseline and Week 12)
- Parameters evaluated by urinalysis(Baseline and Week 12)
- Parameters evaluated by peripheral blood tests(Baseline and Week 12)
研究者
研究点 (2)
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