Measuring Effects of Prebiotics on Human Behavior and Cognition

NCT04055246 | Completed

• 1 other identifier: Pro00093322
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to test the effects of prebiotics on cognition, behavior and physiology in healthy volunteers.

Conditions

Prebiotics and Human Behavior and Cognition

Outcome Measures

Primary Outcomes (2)

• Change in cognitive test performance from baseline

  We will measure performance on a ten-domain cognitive battery (score out of 1000 for each domain) and compare the change from baseline between treatment and control groups.

  Baseline (Day 2, Day 5), Intervention (Day 9, Day 12), and Post-Intervention (Day 16, Day 19)

• Change in stool microbiota profile from baseline

  Stool samples will be analyzed to determine microbiota composition by 16S rRNA sequencing, and we will compare the change from baseline between treatment and control groups.

  Baseline (Day 2, Day 5), Intervention (Day 9, Day 12), and Post-Intervention (Day 16, Day 19)

Secondary Outcomes (6)

• Change in nighttime salivary cortisol from baseline

  Baseline (Day 1, Day 4), Intervention (Day 8, Day 11), and Post-Intervention (Day 15, Day 18)

• Change in blood metabolites from baseline

  Baseline (Day 2, Day 5), Intervention (Day 9, Day 12), and Post-Intervention (Day 16, Day 19)

• Change in sleep quality from baseline

  Baseline (Days 1-5), Intervention (Days 8-12), and Post-Intervention (Days 15-19)

• Change in sleep quality from baseline

  Baseline (Days 1-5), Intervention (Days 8-12), and Post-Intervention (Days 15-19)

• Change in heart rate from baseline

  Smart watches will be used to continuously monitor heart rate, and we will compare the change from baseline between treatment and control groups

Study Arms (2)

Prebiotic

EXPERIMENTAL

Participants receive prebiotics containing fiber bar to consume 2x daily for 1 week.

Dietary Supplement: Inulin

Placebo

PLACEBO COMPARATOR

Participants receive placebo bar containing no added prebiotics to consume 2x daily for 1 week.

Dietary Supplement: Placebo (maltodextrin)

Interventions

Inulin DIETARY_SUPPLEMENT

9 grams of food grade inulin added to custom made fiber bars.

Prebiotic

Placebo (maltodextrin) DIETARY_SUPPLEMENT

9 grams of food grade maltodextrin - replaces inulin in fiber bars.

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Between age 18 and 35
• Able to provide stool samples at no risk to yourself
• Weigh at least 110 pounds
• Physically able to perform a cognitive examination administered on a laptop with a trackpad (no significant language, hearing, visual or sensory-motor problems)

You may not qualify if:

• History or current diagnosis of acute or active major psychiatric disorder (major depressive disorder, generalized anxiety disorder, post-traumatic stress disorder, schizophrenia, bipolar disorder, alcohol or drug dependence, etc)
• History or current diagnosis of any neurological disorder (convulsion or seizure disorder, epilepsy, Huntington's Disease, Multiple Sclerosis, ALS, Parkinson's, dementia, stroke, etc)
• Use of steroid medications, including but not limited to steroid inhalers or creams or lotions that contain steroids, such as hydrocortisone
• Drink greater than 2 alcoholic beverages per day on average
• Recreational drug use, including but not limited to marijuana, cocaine, ecstasy, etc, within the past month
• Known food allergies to soy products
• Dietary restrictions/allergies of milk or dairy products including food products that do not contain nuts, peanuts, eggs, or shellfish, but was manufactured in the same space as these food allergens
• History or current diagnosis of autism or pervasive development disorder
• History or current diagnosis of any learning disability
• History of fainting during blood draws
• Use chewing tobacco
• Currently pregnant
• Currently breastfeeding
• BMI higher than 27.5 or less than 17
• History or current diagnosis of irritable bowel syndrome

Sponsors & Collaborators

• Duke University: lead
• Office of Naval Research (ONR): collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27708, United States

Location

MeSH Terms

Interventions

Inulin; maltodextrin

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Fructans; Polysaccharides

Study Officials

• Lawrence David, Ph. D.

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2019
• First Posted: August 13, 2019
• Study Start: June 4, 2019
• Primary Completion: March 23, 2020
• Study Completion: March 23, 2020
• Last Updated: February 3, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)