Clinical trial NCT04901390: Impact of Yogurt on Gastrointestinal Health, Regularity, and Thoughts
Official title: Impact of Yogurt on Gastrointestinal Health, Regularity, and Thoughts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Dysfunction
Physiological Stress
Cognition - Other
Keywords: gastrointestinal transit time
mood
emotion
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
Collaborators: name: National Honey Board
First posted: 2021-05-25
Enrollment: 66
Sex: ALL
Minimum age (years): 22
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Controlled single-group trial with a 4-week lead-in period and a 2-week treatment period. The treatment will consist of yogurt with sugar.
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* 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\^2.
* 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)

Exclusion Criteria:

* 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))

Primary outcomes:
measure: Intestinal transit time measured using colored dye markers
timeFrame: 2 weeks
Secondary outcomes:
measure: Digestive health measured using daily stool records with the Bristol Stool Scale
timeFrame: 2 weeks
measure: Digestive health measured using rating scales of additional symptoms in daily stool records
timeFrame: 2 weeks
measure: Digestive health measured using the Gastrointestinal Tolerability questionnaire
timeFrame: 2 weeks
measure: Digestive health measured using the Gastrointestinal Quality of Life Index (GIQLI) questionnaire
timeFrame: 2 weeks
measure: Mood measured using the Emotional Image Task
timeFrame: 2 weeks
measure: Mood measured using the Positive and Negative Affect Schedule (PANAS) questionnaire
timeFrame: 2 weeks
measure: Mood measured using the Depression, Anxiety, and Stress Scales-42 (DASS-42) questionnaire
timeFrame: 2 weeks
measure: Mood measured using Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaires
timeFrame: 2 weeks
measure: Cognitive function measured using the Spatial Reconstruction Task
timeFrame: 2 weeks
measure: Gastrointestinal microbiota assessed using relative abundances
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Urbana
country: United States
facility: University of Illinois at Urbana-Champaign
state: Illinois
Study officials:
References: