Dairy Products to Your Gut and Brain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Difference in change from baseline in defecation frequency between the interventions
研究概览
简要总结
The goal of this intervention study is to compare the effects of fermented dairy and non-fermented dairy on bowel habits and cognitive performance in healthy women with defecations every other day or less. Furthermore, the study aims to explore underlying mechanisms linking the gut and the brain.
In addition, a sub-study will be conducted to explore differences in gut and brain measures between women with daily (reference group) and few (intervention group) weekly bowel movements, respectively, and to explore associations between measures of gut- and brain function.
详细描述
Participants in the intervention study (n=60) will consume 300g of fermented dairy (yogurt) or non-fermented dairy (milk) daily for 4 weeks. After a washout period of at least 4 weeks, the participants will consume the alternative dairy product (yogurt or milk) for 4 weeks. The participants will collect samples at home and be tested at the institute before and after each condition (yogurt or milk).
Participants in the sub-study (n=40) will not undergo any dairy interventions and they will only take part in the baseline assessments.
Prior to all visits at the institute, the participants are asked to complete some study activities at home, including:
- consumption of sweet corns to estimate whole gut transit time
- collection of fecal- and urine samples
- measurement of methane and hydrogen in breath
- reporting of gastrointestinal symptoms, including stool frequency and Bristol Stool Scale
During all visits at the institute, the participants will undergo tests and measurements, including:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Self-reported defecations every second day or less (intervention study only)
- •Willing to consume 300g milk/yogurt on a daily basis (intervention study only)
- •Owns a smartphone (iOS 11.0 and later or Android 5.0 and up)
- •Understand Danish or English
排除标准
- •Current pregnancy or lactation
- •Dairy allergy or intolerance
- •Prior diagnosis of psychiatric or neurological illness
- •Current diagnosis of depression, anxiety, or stress
- •Prior diagnosis of metabolic or gastrointestinal disease (e.g., cardiovascular disease, diabetes, chronic constipation or diarrhea, inflammatory bowel diseases (IBD), celiac disease, small intestinal bacterial overgrowth (SIBO), cancer, etc.)
- •Use of antibiotics within the last month
- •Use of peroral corticosteroids (inhalers excepted)
- •Use of medications that alter normal bowel function and metabolism (e.g., laxatives, antidiarrheal agents, narcotics, diuretics, anticonvulsants, etc.)
- •Use of neuroactive medications (e.g., antidepressants, anxiolytics, anticonvulsants, antipsychotics, antiparkinsonian, etc.)
- •Concurrent participation in another trial
- •Any condition that makes the project responsible researcher doubt the feasibility of the volunteer´s participation
研究组 & 干预措施
Fermented dairy
The fermented dairy product is Arla A38® naturel 1,5% yogurt. The yogurt contains Lactobacillus acidophilus culture.
干预措施: Fermented dairy (Other)
Non-fermented dairy
The non-fermented dairy product is Arla® Letmælk 1,5% (semi-skimmed milk). The fermented- and non-fermented dairy products are isocaloric and matched in macronutrient content.
干预措施: Non-fermented dairy (Other)
结局指标
主要结局
Difference in change from baseline in defecation frequency between the interventions
时间窗: Baseline and 4 weeks
Participants will report all bowel movements in a defecation diary in the week leading up to the intervention (baseline) and in the last week of the intervention (week 4)
次要结局
- Difference in change from baseline in phase-amplitude coupling between gastric slow-wave activity and cortical alpha activity between the interventions(Baseline and 4 weeks)
- Difference in change from baseline in cognitive performance between the interventions(Baseline and 4 weeks)
- Difference in change from baseline in self-reported gastrointestinal symptoms between the interventions(Baseline and 4 weeks)
- Difference in change from baseline in stool consistency between the interventions(Baseline and 4 weeks)
- Difference in change from baseline in fecal abundance of Lactobacillus acidophilus between the interventions(Baseline and 4 weeks)
- Difference in change from baseline in whole gut transit time between the interventions(Baseline and 4 weeks)
- Difference in change from baseline in stool moisture between the interventions(Baseline and 4 weeks)
研究者
Henrik Munch Roager
Associate Professor
University of Copenhagen