Randomized Controlled Intervention Study to Analyze the Efficacy of a Dietary Ingredient Combination With Omega-3 for Joint Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Change in Pain from baseline at 8 weeks
研究概览
简要总结
Randomized, controlled, double-blind intervention study of four parallel branches depending on the product consumed, to analyze the efficacy of an Omega-3 based product on the mobility and functionality of the evaluated joint.
详细描述
The duration of the study will be 60 days (8 weeks). Each day they will have to consume the product under investigation. Subjects who meet the selection criteria will be randomized into each of the study groups (A, B, C o D, depending on the group in which they have been randomized). Each day the subjects will have to fill in a diary regarding pain and concomitant medication.
They will make a total of two visits to the research laboratory and will perform the tests pre-established in the protocol. In addition, a follow-up telephone call will be made after 30 days of consume. Subsequently, a statistical analysis will be performed with the variables measured in the study to obtain the results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults (age: 40-75 YO).
- •Subjects must have persistent knee pain with a baseline VAS pain assessment score of at least 30 mm.
- •Subjects should not present narcotic drugs or steroidal anti-inflammatory drugs or immunosuppressants in their treatment.
排除标准
- •Serious or terminal illnesses.
- •Subjects currently taking glucosamine, chondroitin sulfate, collagen or hyaluronic infiltrations or any supplement indicated for joint health.
- •Subjects who are currently consuming or have consumed in the last two months any Omega-3 based supplement and/or supplement based on the botanical ingredient under investigation.
- •Subjects with chronic inflammatory diseases that affect the musculoskeletal system (rheumatoid arthritis, gout, pseudo-gout, Paget's disease, chronic pain syndrome, etc.).
- •Subjects with a body mass index above
- •Subjects with known allergy to any of the study components.
- •Pregnant or lactating women.
- •Inability to understand informed consent.
研究组 & 干预措施
Combination of Omega-3 based product and botanical ingredient
Consumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon.
干预措施: Omega-3 and/or botanical ingredient (Dietary Supplement)
Omega-3 based product
Consumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon.
干预措施: Omega-3 and/or botanical ingredient (Dietary Supplement)
Botanical ingredient
Consumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon.
干预措施: Omega-3 and/or botanical ingredient (Dietary Supplement)
Control group
Consumption for 60 days. Subjects should consume two capsules in the morning and two capsules in the afternoon.
干预措施: Control product consumption (Other)
结局指标
主要结局
Change in Pain from baseline at 8 weeks
时间窗: The evolution of pain after consumption during 8 weeks will be measured.
Visual analog scale from 0 to 10. The higher the value, the more pain.
Quality of life test: WOMAC test
时间窗: Change in initial quality of life at 8 weeks.
The quality of life of the subjects will be measured with the WOMAC test. It is a 24-item test that will measure the degree of pain: nothing, little, enough and a lot, when performing activities in daily life.
次要结局
- Sleep quality(It will be measured twice, once at baseline or at the end of the study after 8 weeks of use)
- Waist - hip circumference(The test will be measured at baseline and after 8 weeks of consumption.)
- Body composition(The test will be measured at baseline and after 8 weeks of consumption.)
- Functional test(The test will be measured at baseline and after 8 weeks of consumption.)
- Sleep efficiency(The test will be measured at baseline and after 8 weeks of consumption. It will be measured during 3 weekdays and one weekend day.)
- Physical activity(The test will be measured at baseline and after 8 weeks of consumption. It will be measured during 3 weekdays and one weekend day.)
- Physical activity control(The test will be measured at baseline and after 8 weeks of consumption.)
- Change in Pain from baseline at 8 weeks(Pain will be measured with a daily scale, from baseline to 8 weeks.)
- Change in concomitant analgesic medication(The test will be measured at baseline and after 8 weeks of consumption. It will also be evaluated on a daily basis)
- Liver safety variables(It will be measured twice, once at baseline or at the end of the study after 8 weeks.)
- Muscle function(The test will be measured at baseline and after 8 weeks of consumption.)
- Omega-3 Bioavailability(It will be measured twice, once at baseline or at the end of the study after 8 weeks.)
研究者
Francisco Javier López Román
Principal Investigator
Universidad Católica San Antonio de Murcia