A Double-blind Randomized Clinical Study Investigating Lactobacillus Reuteri Supplementations Influence on Testosterone Levels in Healthy Men
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- BioGaia AB
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Concentration of total testosterone
研究概览
简要总结
This study evaluates the effect of L. reuteri ATCC PTA 6475 supplementation on testosterone in men.
详细描述
The probiotic Lactobacillus reuteri ATCC PTA 6475 has been shown to modulate testosterone levels in mice. It is not known if these effects are seen in humans and this trial is intended to study this.
The aim of this study is to investigate if L. reuteri ATCC PTA 6475 will effect blood testosterone levels in in healthy male subjects 50-65 years of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Willing and able to give signed informed consent for participation in the study.
- •Healthy males aged between 50-65 with no known underlying medical conditions
- •Subjects who are capable of taking themselves to testing centre at 3 separate timepoints (Baseline, week 6 and week 12).
- •Subjects who are available to give fasting blood samples before 10am on day of blood sample collection
- •No history of androgen or testosterone supplementation within 6 months prior to study start.
- •Subjects who have not been taking antibiotics or probiotic supplements 4 weeks prior to study start
- •Able and willing to comply with the restirictions defined for the study period
- •Ability to understand and comply with the requirements of the study, as judged by the investigator physician
排除标准
- •Subjects who presently have or have had cardiovascular issues in the past 2 years.
- •Subjects who have a Body Mass Index of < 18 or > 30
- •Known elevated Prostate Specific Antigen levels.
- •History of prostate or testicular cancer.
- •Nicotine abuse
- •Alcohol abuse
研究组 & 干预措施
L. reuteri Low Dose
L. reuteri will be delivered in a capsule at a low dose including Vitamin D3. Administration twice daily.
干预措施: Lactobacillus reuteri (L. reuteri) (Dietary Supplement)
L. reuteri High Dose
L. reuteri will be delivered in a capsule at a high dose including Vitamin D3. Administration twice daily.
干预措施: Lactobacillus reuteri (L. reuteri) (Dietary Supplement)
Placebo
The placebo product will be identical to the active product in taste and appearance and include Vitamin D3 but without the L. reuteri. Administration twice daily.
干预措施: Lactobacillus reuteri (L. reuteri) (Dietary Supplement)
结局指标
主要结局
Concentration of total testosterone
时间窗: Baseline, 6 weeks, 12 weeks
Change in total testosterone concentration over time
次要结局
- Free testosterone index(Baseline, 6 weeks, 12 weeks)
- Number of adverse events(Continously 12 weeks)
- Percentage of hematokrit(Baseline, 6 weeks, 12 weeks)