NECTAR Study: Nectar (Honey) Effects on Comfort, Thoughts, and Regularity
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 with honey provides beneficial effects on digestive health and subjective mood in healthy adults.
详细描述
This clinical trial will be a randomized, controlled, double-blind, crossover study with two 2-week treatment conditions separated by at least a 4-week washout period between conditions. Participant flow through the study conditions will be counterbalanced. Participants will be randomly allocated to yogurt with honey first or control first. Before beginning the first intervention period, participants will undergo a 2-week lead-in period that is 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.
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 (Participant)
盲法说明
Participants will be blinded to the order in which they receive the study treatments.
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
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
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 honey on intestinal transit time in vivo compared to control, yogurt containing heat-inactivated B.lactis with added sugar. Intestinal transit time will be measured using colored dye markers.
次要结局
- Mood measured using the Depression, Anxiety, and Stress Scales-42 (DASS-42) questionnaire(2 weeks)
- Gastrointestinal microbiota assessed using relative abundances(2 weeks)
- Mood measured using the Emotional Image Task(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)
- Digestive health measured using daily stool records with the Bristol Stool Scale(2 weeks)
- Mood measured using Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaires(2 weeks)
- Mood measured using the Positive and Negative Affect Schedule (PANAS) questionnaire(2 weeks)
- Cognitive function assessed using the Spatial Reconstruction Task(2 weeks)