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Trial record 31 of 98 for:    grams | maltodextrin

Measuring Effects of Prebiotics on Human Behavior and Cognition

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ClinicalTrials.gov Identifier: NCT04055246
Recruitment Status : Recruiting
First Posted : August 13, 2019
Last Update Posted : August 15, 2019
Sponsor:
Collaborator:
Office of Naval Research (ONR)
Information provided by (Responsible Party):
Duke University

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

Condition or disease Intervention/treatment Phase
Prebiotics and Human Behavior and Cognition Dietary Supplement: Inulin Dietary Supplement: Placebo (maltodextrin) Not Applicable

Detailed Description:

The purpose of this study is to determine the effects of dietary carbohydrate supplements (prebiotics) on cognition, behavior and physiology in healthy individuals.

This study will be separated into one pre-study visit + three consecutive weeks: Baseline (week 1), Intervention (week 2) and Assessment (week 3). For these three weeks, participants will be asked to take diet surveys and make in-person visits to complete online cognitive assessments and provide samples of blood and saliva to assess levels of serotonin and cortisol in addition to other basic metabolites. During the Intervention week, participants will be given snack bars that they will be asked to eat twice a day, for five days in a row. There will be two treatment groups that participants will be randomly assigned to, which vary according to the carbohydrate makeup of snack bars. For the entire three-week study period, participants will also be asked to collect samples of their stool at home every Tuesday and Friday. They will also be provided with wearable devices (a watch) to track their daily heart rate and activity level (including sleep) for the entirety of the study. Participants will be compensated for their time for each stage of the study, once in-person visits begin.

The greatest risks of this study include the possibility of infection while sampling your own stool, and momentary discomfort and/or bruising associated with blood draws. Infection, fainting and excess bleeding/clotting, though highly unlikely, are possible. Participants also face risks associated with the loss of confidentiality.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Measuring Effects of Prebiotics on Human Behavior and Cognition
Actual Study Start Date : May 23, 2019
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Inulin

Arm Intervention/treatment
Experimental: Prebiotic
Participants receive prebiotics containing fiber bar to consume 2x daily for 1 week.
Dietary Supplement: Inulin
9 grams of food grade inulin added to custom made fiber bars.

Placebo Comparator: Placebo
Participants receive placebo bar containing no added prebiotics to consume 2x daily for 1 week.
Dietary Supplement: Placebo (maltodextrin)
9 grams of food grade maltodextrin - replaces inulin in fiber bars.




Primary Outcome Measures :
  1. Change in cognitive test performance from baseline [ Time Frame: Baseline (Day 2, Day 5), Intervention (Day 9, Day 12), and Post-Intervention (Day 16, Day 19) ]
    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.

  2. Change in stool microbiota profile from baseline [ Time Frame: Baseline (Day 2, Day 5), Intervention (Day 9, Day 12), and Post-Intervention (Day 16, Day 19) ]
    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.


Secondary Outcome Measures :
  1. Change in nighttime salivary cortisol from baseline [ Time Frame: Baseline (Day 1, Day 4), Intervention (Day 8, Day 11), and Post-Intervention (Day 15, Day 18) ]
    Saliva samples will be analyzed for cortisol concentration, and we will compare the change from baseline between treatment and control groups.

  2. Change in blood metabolites from baseline [ Time Frame: Baseline (Day 2, Day 5), Intervention (Day 9, Day 12), and Post-Intervention (Day 16, Day 19) ]
    Blood samples will be analyzed for a panel of metabolites that may be influenced by the intestinal microbiota, and we will compare the change from baseline between treatment and control groups

  3. Change in sleep quality from baseline [ Time Frame: Baseline (Days 1-5), Intervention (Days 8-12), and Post-Intervention (Days 15-19) ]
    Smart watches will be used to monitor time asleep each night and we will compare the change in this variable from baseline between treatment and control groups

  4. Change in sleep quality from baseline [ Time Frame: Baseline (Days 1-5), Intervention (Days 8-12), and Post-Intervention (Days 15-19) ]
    Smart watches will be used to monitor percent of time spent in deep sleepwe will compare the change in this variable from baseline between treatment and control groups

  5. Change in heart rate from baseline [ Time Frame: Smart watches will be used to continuously monitor heart rate, and we will compare the change from baseline between treatment and control groups ]
    Baseline (Days 1-5), Intervention (Days 8-12), and Post-Intervention (Days 15-19)

  6. Change in stool short-chain fatty acid (SCFA) content from baseline [ Time Frame: Baseline (Day 2, Day 5), Intervention (Day 9, Day 12), and Post-Intervention (Day 16, Day 19) ]
    Stool samples will be analyzed to determine initial concentrations of SCFAs and capacity to produce SCFAs in response to a prebiotic intervention in vitro, and we will compare the change from baseline in these variables between treatment and control groups



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  • History or current diagnosis of inflammatory bowel disease
  • History or current diagnosis of type 2 diabetes
  • History or current diagnosis of chronic kidney disease with decreased kidney function
  • History or current diagnosis of intestinal obstruction
  • History or current diagnosis of untreated colorectal cancer
  • Colonoscopy within the past month
  • Oral antibiotics within the past month

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04055246


Contacts
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Contact: Heather Durand, MS 919-681-8767 microcog@duke.edu

Locations
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United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27708
Contact: Heather Durand    919-681-8767    microcog@duke.edu   
Principal Investigator: Lawrence David         
Sponsors and Collaborators
Duke University
Office of Naval Research (ONR)
Investigators
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Principal Investigator: Lawrence David, Ph. D. Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04055246     History of Changes
Other Study ID Numbers: Pro00093322
First Posted: August 13, 2019    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share data at this time.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No