Randomized, Double-blind, Clinical Trial to Evaluate the Effect of a Fermented Dairy Food With Probiotics on Mental Performance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Cognitive performance
研究概览
简要总结
Single-center, randomized, double-blind, placebo-controlled clinical study with two study groups.
One group will consume a product with functional ingredients and the other group will consume a placebo product. will consume a placebo product.
详细描述
When individuals are included in the study they will be randomized in equal proportion to one of the 2 groups of the study. The randomization will be stratified by age taking into account 2 strata (1:1). The first stratum corresponds to an age range of 18 to 40 years and the second stratum to an age range of 41 to 60 years.
The subject must consume the product for 8 weeks and will have a visit 4 weeks later as a follow-up of the study.
At the visits the subject will perform a series of cognitive tests and the intestinal microbiota will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women aged 18-60 years.
- •Individuals with a diagnosis of mild-moderate stress according to the Cohen's perceived stress scale perceived stress scale (PSS-10).
- •Subjects with poor adherence to the Mediterranean diet according to the PREDIMED questionnaire (value below 9 points)*.
- •BMI between 19 and 30 kg/m2.
排除标准
- •Present chronic and/or acute digestive pathologies that may interfere in the absorption of nutrients (inflammatory intestinal diseases, inflammatory bowel absorption of nutrients (inflammatory intestinal diseases, etc.), etc.)
- •Intake of probiotics and/or prebiotics in the four weeks prior to the inclusion in the study.
- •Individuals who are on antibiotic treatment or have completed an antibiotic treatment during the 30 days prior to inclusion in the study.
- •Vegan diet.
- •Being taking any type of supplementation that interacts with cognitive level in the 2 weeks prior to the start of the study.
- •Individuals who had taken or were taking any medications or supplementation for stress management, mood, or to induce sleep in the 2 weeks prior to the start of the study.
- •A history of allergic hypersensitivity or poor tolerance to any component of the products under study.
- •Consumption of 2 or more Standard Drink Units (UBE) daily or 17 weekly in women, or consume 4 or more UBE daily or 28 weekly in men.
- •Smoking and non-smoking subjects who have modified their nicotinic habits in the last 3 months.
- •Pregnant or lactating women.
- •Been participating or have participated in another clinical trial in the 2 months prior to the study to the study.
- •Unwillingness or inability to comply with the procedures of the clinical trial.
- •Subjects with any diagnosed psychiatric disorder.
- •Subjects whose condition makes them ineligible for the study in accordance with the criteria of the investigator.
结局指标
主要结局
Cognitive performance
时间窗: Change in baseline cognitive performance after 8 weeks of consumption
COMPASS cognitive test panel
次要结局
- Gut microbiota(Day 1, at 4, 8 and 12 weeks later)
- Dietary survey(Day 1, at 4, 8 and 12 weeks later)
- Perceived Stress Scale(Day 1, at 4 and 8 weeks later)
- State of mind(Day 1, at 4 and 8 weeks later)
- Stress status using VAS scale(Day 1, at 4 and 8 weeks later)
- Sleep efficiency(It will be measured for 3 days, before starting the consumption of the product, after 30 days of consumption and at the end of consumption (60 days).)
- Sleep quality(Day 1, at 4 and 8 weeks later)
- Adverse events(At 4 weeks, 8 and 12 weeks after consumption)
- Concomitant medication(Day 1, at 4, 8 and 12 weeks later)
- Body weight(Day 1, at 8 weeks later)
- Liver safety variables(It will be measured twice, once at baseline or at the end of the consumption after 8 weeks.)
- Mood profile(Day 1, at 4 and 8 weeks later)
- Depression, Anxiety and Stress(Day 1, at 4 and 8 weeks later)
研究者
Francisco Javier López Román
Principal Investigator
Universidad Católica San Antonio de Murcia