Effects of Dietary Supplementation With Exten(d) Blend on Training Ability in Recreational Runners: A Pilot Randomized, Triple-blind, Placebo Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Effects of Exten(d) herbal blend on knee and popliteus inflammation
研究概览
简要总结
The study will assess running biomechanics and joint inflammation of physically active males between 40 and 60 years of age, mainly runners, suffering from knee joint inflammation and pain after training. Participants were split into two groups, intervention and placebo, to evaluate the safety and efficacy of Exten(d) supplementation during 4 weeks.
详细描述
Triple-blind, randomized, placebo-controlled, parallel group, pilot safety, and efficacy study.
30 healthy physically active males (40 to 60 years old) suffering from knee joint inflammation and pain after training were randomly assigned to the Exten(d) or Placebo group. During the first visit and after 4 weeks supplementation (either 2 g daily of Exten(d) capsules or placebo capsules) the participants were subjected to a three-stage exercise session: (i) running biomechanical assessment, (ii) exercise physiology maximal effort test and (iii) running biomechanical assessment after the incremental exercise to exhaustion. The volunteers have been assessed to determine: (1) inflammation by I-R thermography and pain perception, (2) running technics though biomechanic analysis and (3) performance.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Each pill bottle was assigned a five characters numeric code and a letter (A or B). Then, the codes were randomly distributed to the participants. Once the study finished, an external person to the study revealed the placebo and controlled group for each letter.
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male recreational runners who run for at least 150 minutes per week divided into two or more sessions.
- •The participants were expected to describe some degree of knee inflammation and/or discomfort after training in order to be accepted. Knee discomfort was considered significant whenever a subject referred to a punctuation of ≥ 2 in a Visual Analogue Scale (VAS).
- •Agree not to initiate any new exercise or diet programs during the entire study period
- •Agree not to change their current diet or exercise program during the entire study period
- •Agree not to stretch, utilize ice massage, take anti-inflammatory medications (eg, aspirin, ibuprofen), or use any other treatment during the trial.
排除标准
- •Use of anti-inflammatory medications or pain medications 1 week before the screening visit and during the study
- •Daily use of dietary supplements and herbal supplements beginning at the screening visit and during the study
- •Antibiotic use in the past 3 months
- •Chronic disease
研究组 & 干预措施
Exten(d)
Subjects have to take Exten(d) capsules (3 times a day, total 2 g/day) during breakfast, lunch and diner, during 4 weeks.
干预措施: Polyherbal Exten(d) vs Placebo (Dietary Supplement)
Placebo
Subjects have to take Placebo capsules (3 times a day, total 2 g/day) during breakfast, lunch and diner, during 4 weeks.
干预措施: Polyherbal Exten(d) vs Placebo (Dietary Supplement)
结局指标
主要结局
Effects of Exten(d) herbal blend on knee and popliteus inflammation
时间窗: Changes from baseline at week 4
Knee and popliteus inflammation assessment by IR Thermography after the warm-up, after the first Biomechanical test, after the incremental test to exhaustion and after the second biomechanical test.
Effects of Exten(d) on biomechanicals running technique
时间窗: Changes from baseline running technique at week 4
Biomechanics techniques assessment by VICON technology before and after the incremental test to exhaustion
次要结局
- Enzymes safety variables(Changes from baseline at week 4)
- Impedancemetric variables(Changes from baseline at week 4)
- VO2max(Changes from baseline at week 4)
- knee pain perception(Changes from baseline at week 4)
- Biochemical variables(Changes from baseline at week 4)
- Hematological variables(Changes from baseline at week 4)
研究者
Marcela González-Gross
Proffessor Doctor
Universidad Politecnica de Madrid