Impact of Yogurt on Gastrointestinal Health, Regularity, and Thoughts

NCT04901390 | Completed

• 1 other identifier: 20665
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Dysfunction; Physiological Stress; Cognition - Other

Keywords

gastrointestinal transit time; mood; emotion

Outcome Measures

Primary Outcomes (1)

• 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.

  2 weeks

Secondary Outcomes (10)

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

  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

• Mood measured using the Emotional Image Task

  2 weeks

Study Arms (1)

Yogurt with B. lactis and added cane sugar

EXPERIMENTAL

Participants will consume yogurt with B. lactis and added cane sugar twice daily for 14 days.

Dietary Supplement: Yogurt with B. lactis and added cane sugar

Interventions

Yogurt with B. lactis and added cane sugar DIETARY_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.

Yogurt with B. lactis and added cane sugar

Eligibility Criteria

• Age: 22 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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))

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead
• National Honey Board: collaborator

Study Sites (1)

University of Illinois at Urbana-Champaign

Urbana, Illinois, 61801, United States

Location

Related Publications (1)

• Mysonhimer AR, Brown MD, Alvarado DA, Cornman E, Esmail M, Abdiel T, Gutierrez K, Vasquez J, Cannavale CN, Miller MJ, Khan NA, Holscher HD. Honey Added to Yogurt with Bifidobacterium animalis subsp. lactis DN-173 010/CNCM I-2494 Supports Probiotic Enrichment but Does Not Reduce Intestinal Transit Time in Healthy Adults: A Randomized, Controlled, Crossover Trial. J Nutr. 2024 Aug;154(8):2396-2410. doi: 10.1016/j.tjnut.2024.05.028. Epub 2024 Jun 1.

  PMID: 38830472 DERIVED

MeSH Terms

Interventions

Yogurt

Intervention Hierarchy (Ancestors)

Cultured Milk Products; Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Fermented Foods; Dairy Products; Food; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participants will be blinded to the ingredient (sugar) added to the yogurt.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: May 25, 2021
• Study Start: September 20, 2021
• Primary Completion: November 23, 2022
• Study Completion: November 23, 2022
• Last Updated: July 21, 2023

Record last verified: 2023-07

Locations

US (1)