An Exploratory Study on the Effect of Fermented Dairy Protein With Prebiotic Fiber in Athletes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Change in daily self-reported digestive comfort
研究概览
简要总结
Healthy participants with self-reported GI complaints will consume the protein supplement that they normally use for recovery purposes after exercise during a 3-week baseline period, followed by a 3-week intervention period in which they maintain usage of their product, but replace a part of this product with a fermented dairy protein with prebiotic fiber. In addition, a group of healthy participants without self-reported GI complaints will serve as a reference group by consuming the protein supplement that they normally use for recovery purposes after exercise during a 3-week period.
详细描述
A substantial number of athletes suffer from gastro-intestinal problems, which may impair performance and/or subsequent recovery. Also, gut barrier integrity is impaired with high-intensity training. Emerging studies are showing a positive correlation between the gut microbiome and muscle function, athletic performance, body composition, and natural energy levels. This study will perform an exploratory analysis of the well-being and digestive health of well-trained athletes, and assess the potential effect of fermented dairy protein with prebiotic fiber on these parameters.
Question 1: Does the 3-week supplementation of a fermented dairy protein with prebiotic fiber affect the self-reported digestive comfort compared to a 3-week baseline period? And additionally, will the quality of life (self-reported general well-being and states of mood) change with the use of this type of product?
Question 2: Does the 3-week supplementation of a fermented dairy protein with prebiotic fiber show an alteration in gut microbiota in comparison to a 3-week baseline period, while dietary intake remains unaffected?
Question 3: How is the 3-week supplementation of a fermented dairy protein with prebiotic fiber experienced by the participants (taste and concept liking)?
Question 4: Is there a difference in baseline gut microbiota between athletes with and athletes without self-reported GI complaints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects living in Arizona in the USA
- •Women/Men aged between 18-35 years
- •Serious athletes (exercise at least 3 x per week)
- •With or without GI tract issues due to sport or protein/diet intake
- •18.5 ≤ BMI ≤ 40 kg/m2
- •No physical limitations (i.e. able to perform all activities associated with daily living in an independent manner).
- •Use of a protein supplement or sports food after at least one training per day 3 x per week
- •Willing to slightly increase their protein supplement intake during the intervention phase for 21 consecutive days
- •Stable weight during the last 4 weeks, without a focus on body weight reduction through limiting caloric intake
- •Written informed consent
排除标准
- •Daily use of (sport) supplements containing probiotics and/or prebiotics
- •Self-reported cow's milk protein allergy
- •Clinical lactose intolerance
- •Clinical milk protein allergy
- •House dust mite allergy
- •Diagnosed GI tract disorders or diseases
- •Musculoskeletal disorders
- •Metabolic disorders (such as diabetes)
- •Use of any medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescribed acne medications).
- •Chronic use of gastric acid-suppressing medication or anti-coagulants
- •Use of antibiotics or anti-inflammatory medication the past 2 weeks
- •Blood donation in the past 2 months
- •Pregnant/lactating women
- •Athletes should not aim to lose body weight by reducing energy intake during the study
结局指标
主要结局
Change in daily self-reported digestive comfort
时间窗: Study period covering day 1 to day 21 compared to day 22-42.
Daily variation of GI complaints (averaged itemized score 1-10)
Change in self-reported digestive comfort
时间窗: Baseline (day 0), after 21 days and after 42 days.
Gastrointestinal Symptoms Rating Scores (GSRS-score: Average of all 5 sub-scores)
次要结局
- Change in self-reported general wellbeing - Psychological Distress(Baseline (day 0), after 21 days and after 42 days.)
- Change in dietary intake(Baseline (day 0), after 21 days and after 42 days.)
- Change in self-reported general wellbeing - Physical Health(Baseline (day 0), after 21 days and after 42 days.)
- Chane in self-reported states of mood(Baseline (day 0), after 21 days and after 42 days.)
- Change in participants microbiota composition of fecal samples(Baseline (day 0), after 21 days and after 42 days.)