Impact of Yogurt on Gastrointestinal Health, Regularity, and Thoughts
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Intestinal transit time measured using colored dye markers
研究概览
简要总结
This study aims to test the central hypothesis that adding to the diet daily yogurt provides beneficial effects on digestive health and subjective mood in healthy adults.
详细描述
This clinical trial will include a 4-week lead-in period and a 2-week treatment period. The lead-in period will be devoid of all supplemental and dietary probiotics, fermented dairy products, and fermented foods. Participants will be asked to refrain from consuming all supplemental and dietary probiotics, fermented dairy products, and fermented foods throughout the entire study. During the treatment period, participants will be given yogurt with sugar. This trial will serve as a continuation of the NECTAR Study (NCT04187950).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
Participants will be blinded to the ingredient (sugar) added to the yogurt.
入排标准
- 年龄范围
- 22 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females
- •Between the ages of 22-64 years at the time of consent
- •Body mass index of 18.5 to 29.9 kg/m^
- •Normal or corrected-to-normal vision based on the minimal 20/20 standard in order to complete the cognitive task (below 20/20 vision).
- •Ability to drop off fecal sample within 30 minutes of defecation
- •Have between 3-6 bowel movements per week
- •Have completed the NECTAR Study (NCT04187950)
排除标准
- •Current pregnancy, lactation, or post-menopausal
- •Tobacco use
- •Honey allergy or intolerance
- •Dairy allergy, lactose intolerance
- •Food dye allergy/intolerance
- •Prior physician diagnosed gastrointestinal disease (chronic constipation, diarrhea, Crohn's disease, celiac disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers, hepatitis, or gastroesophageal reflux disease (GERD))
- •Current use or use of antibiotics in the past 3 months
- •Current use of any of the following types of medications: laxatives, anti-diarrhea medications, narcotics, enemas, antispasmodics, anticonvulsants, prescription proton pump inhibitors, prokinetic agents, histamine-2 Rc antagonists (prescription GERD medication)
- •Body mass index > 29.9 kg/m^2
- •Prior malabsorptive bariatric surgery (i.e. gastric bypass, sleeve gastrectomy)
- •Restrictive bariatric surgery (i.e. adjustable gastric band) within the past 5 years
- •Concurrent enrollment in another dietary, exercise, or medication study (except for the NECTAR Study (NCT04187950))
结局指标
主要结局
Intestinal transit time measured using colored dye markers
时间窗: 2 weeks
Determine the impact of consumption of daily yogurt with sugar on intestinal transit time in vivo. Intestinal transit time will be measured using colored dye markers.
次要结局
- Digestive health measured using daily stool records with the Bristol Stool Scale(2 weeks)
- Mood measured using the Emotional Image Task(2 weeks)
- Mood measured using the Positive and Negative Affect Schedule (PANAS) questionnaire(2 weeks)
- Mood measured using the Depression, Anxiety, and Stress Scales-42 (DASS-42) questionnaire(2 weeks)
- Mood measured using Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaires(2 weeks)
- Gastrointestinal microbiota assessed using relative abundances(2 weeks)
- Digestive health measured using rating scales of additional symptoms in daily stool records(2 weeks)
- Digestive health measured using the Gastrointestinal Tolerability questionnaire(2 weeks)
- Digestive health measured using the Gastrointestinal Quality of Life Index (GIQLI) questionnaire(2 weeks)
- Cognitive function measured using the Spatial Reconstruction Task(2 weeks)