Physiological StressEPOCH-2NCT04551937
Effects of Prebiotics on Cognition and Health
A study testing Lactose Free 1% Milk and Lactose Free 1% Milk + 10 g prebiotic in people with Physiological Stress and Cognitive Change, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
This research intervention aims to examine the effects of prebiotic consumption on changes in behavioral and biological measures of cognition and stress among adults. Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Physiological Stress, Cognitive Change, Gastrointestinal Health
- What is being tested?
- Lactose Free 1% Milk and Lactose Free 1% Milk + 10 g prebiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2018to 18 Sep 2018
- 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 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Prebiotics on Behavioral and Biological Markers of Cognition and Stress
This research intervention aims to examine the effects of prebiotic consumption on changes in behavioral and biological measures of cognition and stress among adults.
Read the detailed description
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.
- Being tested
- Lactose Free 1% Milk, Lactose Free 1% Milk + 10 g prebiotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactose Free 1% MilkOther
Also called Control
8 oz of study beverage daily
Lactose Free 1% Milk + 10 g prebioticOther
8 oz of study beverage supplemented with 5 grams of fructooligosaccharide and 5 grams of galactooligosaccharide
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | 4-5 week period where participant will consume control beverage Receives: Other: Lactose Free 1% Milk |
| Prebiotic | Experimental | 4-5 week period where participant will consume the intervention beverage Receives: Other: Lactose Free 1% Milk + 10 g prebiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biological markers of stress
Changes in 24-hour urinary cortisol, inflammatory markers (e.g. IL-6, CRP).
Measured: 4-5 weeks
Behavioral markers of stress
Change in reported questionnaire responses specific to depression, stress, and anxiety using the Depression, Anxiety, and Stress (DASS) Questionnaire.
Measured: 4-5 weeks
Secondary outcomes (5)
Gastrointestinal Microbiota composition
Impact on bacterial genera abundances.
Measured: 4-5 weeks
Gastrointestinal microbiota beta-diversity
Impact on beta-diversity measures
Measured: 4-5 weeks
Gastrointestinal Microbiota alpha-diversity
Impact on alpha-diversity measures
Measured: 4-5 weeks
Cognitive function
Computer tasks will be used to assess working memory, interference control, cognitive flexibility, and hippocampal function/relational memory
Measured: 4-5 weeks
Sleep
The Pittsburg Sleep Quality Index (PSQI) will also be used to assess sleep, as will actigraphy.
Measured: 4-5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start14 Feb 2018
- Primary completion18 Sep 2018
- Study completion18 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physiological StressStudies of the same condition, open and under way.
- 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
- Crossover
- Model description
- Participants will pass through 2 arms, control and prebiotic, in a randomized, counterbalanced order.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hannah Holscher, University of Illinois at Urbana-Champaign
- Investigators
- Hannah Holscher, PhD, RD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04551937
- Sponsor's protocol ID
- 16840
- Acronym
- EPOCH-2
- Status last verified
- Sep 2020
- First submitted
- 6 Jul 2018
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mysonhimer AR, Cannavale CN, Bailey MA, Khan NA, Holscher HD. Prebiotic Consumption Alters Microbiota but Not Biological Markers of Stress and Inflammation or Mental Health Symptoms in Healthy Adults: A Randomized, Controlled, Crossover Trial. J Nutr. 2023 Apr;153(4):1283-1296. doi: 10.1016/j.tjnut.2023.02.015. Epub 2023 Feb 24.
PubMed 36841506
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Prebiotics on Behavioral and Biological Markers of Cognition and Stress
- ClinicalTrials.gov ID
- NCT04551937
- Acronym / sponsor ID
- EPOCH-2 / 16840
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- 14 Feb 2018 (actual)
- Primary completion
- 18 Sep 2018 (actual)
- Study completion
- 18 Sep 2018 (actual)
- First posted
- 16 Sep 2020 (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 research intervention aims to examine the effects of prebiotic consumption on changes in behavioral and biological measures of cognition and stress among adults.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will pass through 2 arms, control and prebiotic, in a randomized, counterbalanced order.
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: Lactose Free 1% Milk4-5 week period where participant will consume control beverage |
| Prebiotic | Experimental | Other: Lactose Free 1% Milk + 10 g prebiotic4-5 week period where participant will consume the intervention beverage |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Lactose Free 1% MilkAlso: Control8 oz of study beverage daily | Other | Control |
| Lactose Free 1% Milk + 10 g prebiotic8 oz of study beverage supplemented with 5 grams of fructooligosaccharide and 5 grams of galactooligosaccharide | Other | Prebiotic |
Primary outcome
Biological markers of stress
Time frame: 4-5 weeks
Changes in 24-hour urinary cortisol, inflammatory markers (e.g. IL-6, CRP).
Behavioral markers of stress
Time frame: 4-5 weeks
Change in reported questionnaire responses specific to depression, stress, and anxiety using the Depression, Anxiety, and Stress (DASS) Questionnaire.
5 secondary outcomes
Gastrointestinal Microbiota composition
Time frame: 4-5 weeks
Gastrointestinal microbiota beta-diversity
Time frame: 4-5 weeks
Gastrointestinal Microbiota alpha-diversity
Time frame: 4-5 weeks
Cognitive function
Time frame: 4-5 weeks
Sleep
Time frame: 4-5 weeks
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 16 Sep 2020.
- Derived from this study: PubMed 36841506Mysonhimer AR, Cannavale CN, Bailey MA, Khan NA, Holscher HD. Prebiotic Consumption Alters Microbiota but Not Biological Markers of Stress and Inflammation or Mental Health Symptoms in Healthy Adults: A Randomized, Controlled, Crossover Trial. J Nutr. 2023 Apr;153(4):1283-1296. doi: 10.1016/j.tjnut.2023.02.015. Epub 2023 Feb 24.
- Individual participant dataSharing planned: No
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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.
Hannah Holscher, PhD, RD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactose Free 1% Milk and Lactose Free 1% Milk + 10 g prebiotic in people with Physiological Stress and Cognitive Change, run by University of Illinois at Urbana-Champaign 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 5 inclusion and 8 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 16 Sep 2020. 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?
Biological markers of stress (time frame: 4-5 weeks). 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?
On the ClinicalTrials.gov record for NCT04551937, which also lists 1 linked publication.
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 16 Sep 2020.