Prebiotics and Human Behavior and CognitionNCT04055246
Measuring Effects of Prebiotics on Human Behavior and Cognition
A study testing Inulin in people with Prebiotics and Human Behavior and Cognition, run by Duke University at 1 site in United States.
Trial summary
This study is designed to test the effects of prebiotics on cognition, behavior and physiology in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Prebiotics and Human Behavior and Cognition
- What is being tested?
- Inulin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2019to 23 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
This study is designed to test the effects of prebiotics on cognition, behavior and physiology in healthy volunteers.
Read the 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. Discomfort as a result of consuming the bars is possible in the form of flatulence, bloating, constipation, diarrhea, or borborygmi (stomach rumbling). Participants weighing less than 140 pounds may be more likely to develop diarrhea than those weighing more. Should any such discomfort occur, it can be alleviated simply by discontinuing consumption of the prebiotic. Infection, fainting, and excess bleeding/clotting, though highly unlikely, are also possible. Participants also face risks associated with the loss of confidentiality.
- Being tested
- Inulin, Placebo (maltodextrin)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InulinDietary supplement
9 grams of food grade inulin added to custom made fiber bars.
Placebo (maltodextrin)Dietary supplement
9 grams of food grade maltodextrin - replaces inulin in fiber bars.
| Study group | Role | What they receive |
|---|---|---|
| Prebiotic | Experimental | Participants receive prebiotics containing fiber bar to consume 2x daily for 1 week. Receives: Dietary Supplement: Inulin |
| Placebo | Placebo comparator | Participants receive placebo bar containing no added prebiotics to consume 2x daily for 1 week. Receives: Dietary Supplement: Placebo (maltodextrin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Saliva samples will be analyzed for cortisol concentration, and we will compare the change from baseline between treatment and control groups.
Measured: Baseline (Day 1, Day 4), Intervention (Day 8, Day 11), and Post-Intervention (Day 15, Day 18)
Change in blood metabolites from baseline
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
Measured: Baseline (Day 2, Day 5), Intervention (Day 9, Day 12), and Post-Intervention (Day 16, Day 19)
Change in sleep quality from baseline
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
Measured: Baseline (Days 1-5), Intervention (Days 8-12), and Post-Intervention (Days 15-19)
Change in sleep quality from baseline
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
Measured: Baseline (Days 1-5), Intervention (Days 8-12), and Post-Intervention (Days 15-19)
Change in heart rate from baseline
Baseline (Days 1-5), Intervention (Days 8-12), and Post-Intervention (Days 15-19)
Measured: Smart watches will be used to continuously monitor heart rate, and we will compare the change from baseline between treatment and control groups
Change in stool short-chain fatty acid (SCFA) content from baseline
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
Measured: Baseline (Day 2, Day 5), Intervention (Day 9, Day 12), and Post-Intervention (Day 16, Day 19)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start4 Jun 2019
- Primary completion23 Mar 2020
- Study completion23 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prebiotics and Human Behavior and CognitionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Office of Naval Research (ONR)
- Responsible party
- Sponsor
- Investigators
- Lawrence David, Ph. D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04055246
- Sponsor's protocol ID
- Pro00093322
- Status last verified
- Jan 2022
- First submitted
- 26 Jul 2019
- Last updated
- 3 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share data at this time.
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Effects of Prebiotics on Human Behavior and Cognition
- ClinicalTrials.gov ID
- NCT04055246
- Acronym / sponsor ID
- Pro00093322
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Office of Naval Research (ONR)
- Study start
- 4 Jun 2019 (actual)
- Primary completion
- 23 Mar 2020 (actual)
- Study completion
- 23 Mar 2020 (actual)
- First posted
- 13 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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. Discomfort as a result of consuming the bars is possible in the form of flatulence, bloating, constipation, diarrhea, or borborygmi (stomach rumbling). Participants weighing less than 140 pounds may be more likely to develop diarrhea than those weighing more. Should any such discomfort occur, it can be alleviated simply by discontinuing consumption of the prebiotic. Infection, fainting, and excess bleeding/clotting, though highly unlikely, are also possible. Participants also face risks associated with the loss of confidentiality.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prebiotic | Experimental | Dietary Supplement: InulinParticipants receive prebiotics containing fiber bar to consume 2x daily for 1 week. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo (maltodextrin)Participants receive placebo bar containing no added prebiotics to consume 2x daily for 1 week. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inulin9 grams of food grade inulin added to custom made fiber bars. | Dietary supplement | Prebiotic |
| Placebo (maltodextrin)9 grams of food grade maltodextrin - replaces inulin in fiber bars. | Dietary supplement | Placebo |
Primary outcome
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.
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.
6 secondary outcomes
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)
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)
Change in sleep quality from baseline
Time frame: Baseline (Days 1-5), Intervention (Days 8-12), and Post-Intervention (Days 15-19)
Change in sleep quality from baseline
Time frame: Baseline (Days 1-5), Intervention (Days 8-12), and Post-Intervention (Days 15-19)
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
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
- Individual participant dataSharing planned: No. No plan to share data at this time.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence David, Ph. D. principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inulin in people with Prebiotics and Human Behavior and Cognition, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2022.