Impact of Yogurt on Gastrointestinal Health, Regularity, and Thoughts

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-20

Study Completion Date

2022-11-23

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Gastrointestinal Dysfunction Physiological Stress Cognition - Other

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Participants will be blinded to the ingredient (sugar) added to the yogurt.

Study Groups

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Yogurt with B. lactis and added cane sugar

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

Group Type EXPERIMENTAL

Yogurt with B. lactis and added cane sugar

Intervention Type 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.

Interventions

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Yogurt with B. lactis and added cane sugar

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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))

Minimum Eligible Age

22 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes