NCT02849275

Brief Summary

This research intervention aims to examine the effects of a fermented dairy beverage on changes in behavioral and biological measures of cognition and stress among adults.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 29, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

October 17, 2018

Status Verified

July 1, 2018

Enrollment Period

2.1 years

First QC Date

July 22, 2016

Last Update Submit

October 16, 2018

Conditions

Physiological StressCognition - Other

Outcome Measures

Primary Outcomes (1)

  • Changes in cortisol as a biomarker of stress

    The effects of probiotic consumption on biomarkers of stress

    4-5 weeks

Secondary Outcomes (1)

  • Changes in fecal microbiota populations

    4-5 weeks

Other Outcomes (1)

  • Changes in cognition

    4-5 weeks

Study Arms (2)

Lactose free 1% milk

PLACEBO COMPARATOR

Diet will be recorded with a 7-day diet record and participants will include an isocaloric study treatment containing lactose free 1% milk consumed once daily over 4-5 weeks as a control.

Other: Lactose Free 1% Milk

Probiotic treatment

EXPERIMENTAL

Diet will be recorded with a 7-day diet record and participants will include an isocaloric fermented milk (probiotic), consumed once daily, over 4-5 weeks.

Other: Probiotic Treatment

Interventions

Lactose Free 1% MilkOTHER

isocaloric study treatment containing lactose free 1% milk consumed once daily over 4-5 weeks as a control.

Lactose free 1% milk
Probiotic TreatmentOTHER

Probiotic treatment, consumed once daily, over 4-5 weeks.

Probiotic treatment

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Males and females
  • Between the ages of 25-45 years at the time of consent
  • BMI ≥18.5 kg/m2
  • Normal or corrected-to-normal vision based on the minimal 20/20 standard in order to complete the cognitive task.
  • Ability to drop-off fecal sample within 15 minutes of defecation

You may not qualify if:

  • Current pregnancy or lactation
  • Tobacco use
  • Dairy allergy or intolerance
  • Prior diagnosis of metabolic and gastrointestinal disease (cardiovascular disease and type 1 or type 2 diabetes, chronic constipation, diarrhea, Crohn's disease, celiac disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers, hepatitis, HIV, cancer, etc.)
  • Prior diagnosis of cognitive or physical disability, including ADHD, severe asthma, epilepsy, chronic kidney disease
  • Use of any anti-psychotic, anti-depressant, anti-anxiety, or ADD/ADHD medications
  • Use of medications that alter normal bowel function and metabolism (e.g., recent antibiotic use, laxatives, enemas, anti-diarrheal agents, narcotics, antacids, antispasmodics, diuretics, anticonvulsants).
  • Prior malabsorptive bariatric surgery (i.e. gastric bypass, sleeve gastrectomy) or restrictive bariatric surgery (i.e. adjustable gastric band) within the past 2 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois

Urbana, Illinois, 61801, United States

Location

Related Publications (1)

  • Cannavale CN, Mysonhimer AR, Bailey MA, Cohen NJ, Holscher HD, Khan NA. Consumption of a fermented dairy beverage improves hippocampal-dependent relational memory in a randomized, controlled cross-over trial. Nutr Neurosci. 2023 Mar;26(3):265-274. doi: 10.1080/1028415X.2022.2046963. Epub 2022 Mar 13.

    PMID: 35282787DERIVED

MeSH Terms

Interventions

Milk

Intervention Hierarchy (Ancestors)

BeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and Beverages

Study Officials

  • Hannah Holscher, Ph.D.

    University of Illinois at Urbana-Champaign

    PRINCIPAL INVESTIGATOR

  • Naiman Khan, Ph.D.

    University of Illinois at Urbana-Champaign

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Participants will pass through 2 arms, control and probiotic, in a randomized, counter-balanced order.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Nutrition

Study Record Dates

First Submitted

July 22, 2016

First Posted

July 29, 2016

Study Start

August 1, 2016

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

October 17, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will share

Results will be disseminated by journal articles, thesis or academic papers, conference presentations, and sharing with the funding organization. No subject's identity will be disclosed in any presentation or released without their written permission.

Locations

US(1)