NCT04551937

Brief Summary

This research intervention aims to examine the effects of prebiotic consumption 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 Feb 2018

Shorter than P25 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

Study Start

First participant enrolled

February 14, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2018

Completed
2 years until next milestone

First Posted

Study publicly available on registry

September 16, 2020

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

7 months

First QC Date

July 6, 2018

Last Update Submit

September 9, 2020

Conditions

Physiological StressCognitive ChangeGastrointestinal Health

Outcome Measures

Primary Outcomes (2)

  • Biological markers of stress

    Changes in 24-hour urinary cortisol, inflammatory markers (e.g. IL-6, CRP).

    4-5 weeks

  • Behavioral markers of stress

    Change in reported questionnaire responses specific to depression, stress, and anxiety using the Depression, Anxiety, and Stress (DASS) Questionnaire.

    4-5 weeks

Secondary Outcomes (5)

  • Gastrointestinal Microbiota composition

    4-5 weeks

  • Gastrointestinal microbiota beta-diversity

    4-5 weeks

  • Gastrointestinal Microbiota alpha-diversity

    4-5 weeks

  • Cognitive function

    4-5 weeks

  • Sleep

    4-5 weeks

Study Arms (2)

Control

PLACEBO COMPARATOR

4-5 week period where participant will consume control beverage

Other: Lactose Free 1% Milk

Prebiotic

EXPERIMENTAL

4-5 week period where participant will consume the intervention beverage

Other: Lactose Free 1% Milk + 10 g prebiotic

Interventions

Lactose Free 1% MilkOTHER

8 oz of study beverage daily

Also known as: Control
Control
Lactose Free 1% Milk + 10 g prebioticOTHER

8 oz of study beverage supplemented with 5 grams of fructooligosaccharide and 5 grams of galactooligosaccharide

Prebiotic

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, antianxiety, 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, antispasmodics, diuretics, anticonvulsants).
  • Prior malabsorptive bariatric surgery (i.e. gastric bypass, sleeve gastrectomy) or restrictive bariatric surgery (i.e. adjustable gastric band)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois

Urbana, Illinois, 61801, United States

Location

Related Publications (1)

  • Mysonhimer AR, Cannavale CN, Bailey MA, Khan NA, Holscher HD. Prebiotic Consumption Alters Microbiota but Not Biological Markers of Stress and Inflammation or Mental Health Symptoms in Healthy Adults: A Randomized, Controlled, Crossover Trial. J Nutr. 2023 Apr;153(4):1283-1296. doi: 10.1016/j.tjnut.2023.02.015. Epub 2023 Feb 24.

    PMID: 36841506DERIVED

MeSH Terms

Interventions

MilkPrebiotics

Intervention Hierarchy (Ancestors)

BeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and BeveragesDietary FiberDietary CarbohydratesCarbohydratesPolysaccharides, BacterialPolysaccharidesDietary Supplements

Study Officials

  • Hannah Holscher, PhD, RD

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double blind (participant and investigative team)
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Participants will pass through 2 arms, control and prebiotic, in a randomized, counterbalanced order.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Nutrition

Study Record Dates

First Submitted

July 6, 2018

First Posted

September 16, 2020

Study Start

February 14, 2018

Primary Completion

September 18, 2018

Study Completion

September 18, 2018

Last Updated

September 16, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)