Impact of Yogurt on Gastrointestinal Health, Regularity, and Thoughts

University of Illinois at Urbana-Champaign66 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Gastrointestinal Dysfunction Physiological Stress Cognition - Other

Interventions

Yogurt with B. lactis and added cane sugarDIETARY_SUPPLEMENT

The intervention condition will utilize a commercially available yogurt (Activia) that contains Bifidobacterium animalis lactis DN-173 010/CNCM I-2494 (B. lactis). Participants will consume 170 g of yogurt with cane sugar twice daily for 14 days.

Eligibility

Sex: ALLMin age: 22 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

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))

Locations (1)

University of Illinois at Urbana-Champaign

Urbana, Illinois, United States

Outcomes

Primary Outcomes

Intestinal transit time measured using colored dye markers

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.

Time frame: 2 weeks

Secondary Outcomes

Digestive health measured using daily stool records with the Bristol Stool Scale

Determine the impact of consumption of daily yogurt with sugar on digestive health using daily stool records. Within the records, participants rate stool consistency using the Bristol Stool Scale (1=hard to 7=watery).

Time frame: 2 weeks

Digestive health measured using rating scales of additional symptoms in daily stool records

Determine the impact of consumption of daily yogurt with sugar on other measures of digestive health using daily stool records. Within the records, ratings of additional gastrointestinal symptoms include ease of passage (1=very easy to 5=very difficult, abdominal pain, bloating, burping, flatulence, nausea, reflux, and rumblings (1=absent to 4=severe).

Time frame: 2 weeks

Digestive health measured using the Gastrointestinal Tolerability questionnaire

Determine the impact of consumption of daily yogurt with sugar on other measures of digestive health using the Gastrointestinal Tolerability questionnaire. This questionnaire assesses gastrointestinal health through 6 questions related to gastrointestinal health including nausea, bloating, rumblings, gas/flatulence, abdominal pain, and diarrhea ("no more than usual" to "much more than usual"). Each of the questions pertains to experience of symptoms in the past 7 days.

Time frame: 2 weeks

Digestive health measured using the Gastrointestinal Quality of Life Index (GIQLI) questionnaire

Determine the impact of consumption of daily yogurt with sugar on other measures of digestive health using the Gastrointestinal Quality of Life Index (GIQLI) questionnaire. The GIQLI assesses gastrointestinal health through a series of 36 questions pertaining to daily life and gastrointestinal symptoms experienced in the past 2 weeks.

Data from ClinicalTrials.gov

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