Effects of Prebiotics on Cognition and Health

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-14

Study Completion Date

2018-09-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This research intervention aims to examine the effects of prebiotic consumption on changes in behavioral and biological measures of cognition and stress among adults.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Probiotics on Cognition and Health

NCT02849275

Physiological Stress Cognition - Other

COMPLETED NA

Effect of a Fermented Dairy Food With Probiotics on Mental Performance

NCT05323825

Cognitive Change

COMPLETED NA

Evaluating the Effects of Prebiotics on Sleep, the Gut Microbiome, Cognition, Immune Function and Stress

NCT05239845

Sleep

ACTIVE_NOT_RECRUITING NA

Prebiotics and Mental Health: Behavioural

NCT04616937

Emotion Regulation Anxiety

COMPLETED NA

Probiotic Intervention on Gut Microbiota and Cognitive Functioning in Older Adults With a Mild Cognitive Impairment

NCT05859230

Mild Cognitive Impairment

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Evidence-based dietary strategies provide behavioral means benefiting physical and cognitive function. Pertinent to the proposed work, dietary intake has been recently shown to have the potential to directly influence the gut microbiota composition as well as brain function. Specifically, the consumption of prebiotics or fibers metabolized by gut bacteria may also play a role. These foods are readily available in the marketplace, however, their implications for physical and cognitive function are not clear. Accordingly, the proposed study aims to investigate effects of prebiotic beverage consumption on changes in behavioral and biological measures of cognition and stress among adults.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Physiological Stress Cognitive Change Gastrointestinal Health

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Participants will pass through 2 arms, control and prebiotic, in a randomized, counterbalanced order.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double blind (participant and investigative team)

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

4-5 week period where participant will consume control beverage

Group Type PLACEBO_COMPARATOR

Lactose Free 1% Milk

Intervention Type OTHER

8 oz of study beverage daily

Prebiotic

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

Group Type EXPERIMENTAL

Lactose Free 1% Milk + 10 g prebiotic

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lactose Free 1% Milk

8 oz of study beverage daily

Intervention Type OTHER

Lactose Free 1% Milk + 10 g prebiotic

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Control

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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)

Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes