Status:
COMPLETED
Measuring Effects of Prebiotics on Human Behavior and Cognition
Lead Sponsor:
Duke University
Collaborating Sponsors:
Office of Naval Research (ONR)
Conditions:
Prebiotics and Human Behavior and Cognition
Eligibility:
All Genders
18-35 years
Phase:
NA
Brief Summary
This study is designed to test the effects of prebiotics on cognition, behavior and physiology in healthy volunteers.
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 23 2020
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT04055246
Start Date
June 4 2019
End Date
March 23 2020
Last Update
February 3 2022
Active Locations (1)
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1
Duke University
Durham, North Carolina, United States, 27708