Physiological StressEPOCHNCT02849275
Effects of Probiotics on Cognition and Health
A study testing Lactose Free 1% Milk and Probiotic Treatment in people with Physiological Stress and Cognition - Other, 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 a fermented dairy beverage 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, Cognition - Other
- What is being tested?
- Lactose Free 1% Milk and Probiotic Treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to 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, anti-anxiety, 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, antacids, antispasmodics, diuretics, anticonvulsants).
- Prior malabsorptive bariatric surgery (i.e. gastric bypass, sleeve gastrectomy) or restrictive bariatric surgery (i.e. adjustable gastric band) within the past 2 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Probiotics on Behavioral and Biological Markers of Cognition and Stress
This research intervention aims to examine the effects of a fermented dairy beverage 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 probiotics or foods containing healthful microbial cultures (e.g., fermented milk, yogurts, etc.) are increasingly being recognized as modulators of metabolism, cognition, and stress. 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 probiotic beverage consumption on changes in behavioral and biological measures of cognition and stress among adults.
- Conditions
- Physiological Stress, Cognition - Other
- Being tested
- Lactose Free 1% Milk, Probiotic Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactose Free 1% MilkOther
isocaloric study treatment containing lactose free 1% milk consumed once daily over 4-5 weeks as a control.
Probiotic TreatmentOther
Probiotic treatment, consumed once daily, over 4-5 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Lactose free 1% milk | Placebo comparator | Diet will be recorded with a 7-day diet record and participants will include an isocaloric study treatment containing lactose free 1% milk consumed once daily over 4-5 weeks as a control. Receives: Other: Lactose Free 1% Milk |
| Probiotic treatment | Experimental | Diet will be recorded with a 7-day diet record and participants will include an isocaloric fermented milk (probiotic), consumed once daily, over 4-5 weeks. Receives: Other: Probiotic Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cortisol as a biomarker of stress
The effects of probiotic consumption on biomarkers of stress
Measured: 4-5 weeks
Secondary outcomes (1)
Changes in fecal microbiota populations
The effects of probiotic consumption on fecal microbiota
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 posted29 Jul 2016 (estimated)
- Study startAug 2016
- Primary completionSep 2018
- Study completionSep 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 probiotic, in a randomized, counter-balanced order.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- 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, Ph.D., Principal investigator, University of Illinois at Urbana-ChampaignNaiman Khan, Ph.D., Principal investigator, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02849275
- Sponsor's protocol ID
- 16840-1
- Acronym
- EPOCH
- Status last verified
- Jul 2018
- First submitted
- 22 Jul 2016
- Last updated
- 17 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Results will be disseminated by journal articles, thesis or academic papers, conference presentations, and sharing with the funding organization. No subject's identity will be disclosed in any presentation or released without their written permission.
Publications
Cannavale CN, Mysonhimer AR, Bailey MA, Cohen NJ, Holscher HD, Khan NA. Consumption of a fermented dairy beverage improves hippocampal-dependent relational memory in a randomized, controlled cross-over trial. Nutr Neurosci. 2023 Mar;26(3):265-274. doi: 10.1080/1028415X.2022.2046963. Epub 2022 Mar 13.
PubMed 35282787
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Probiotics on Behavioral and Biological Markers of Cognition and Stress
- ClinicalTrials.gov ID
- NCT02849275
- Acronym / sponsor ID
- EPOCH / 16840-1
- Conditions
- Physiological Stress, Cognition - Other
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 29 Jul 2016 (estimated)
- 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 a fermented dairy beverage 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 probiotics or foods containing healthful microbial cultures (e.g., fermented milk, yogurts, etc.) are increasingly being recognized as modulators of metabolism, cognition, and stress. 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 probiotic 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
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants will pass through 2 arms, control and probiotic, in a randomized, counter-balanced order.
| Arm | Type | Receives |
|---|---|---|
| Lactose free 1% milk | Placebo comparator | Other: Lactose Free 1% MilkDiet will be recorded with a 7-day diet record and participants will include an isocaloric study treatment containing lactose free 1% milk consumed once daily over 4-5 weeks as a control. |
| Probiotic treatment | Experimental | Other: Probiotic TreatmentDiet will be recorded with a 7-day diet record and participants will include an isocaloric fermented milk (probiotic), consumed once daily, over 4-5 weeks. |
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% Milkisocaloric study treatment containing lactose free 1% milk consumed once daily over 4-5 weeks as a control. | Other | Lactose free 1% milk |
| Probiotic TreatmentProbiotic treatment, consumed once daily, over 4-5 weeks. | Other | Probiotic treatment |
Primary outcome
Changes in cortisol as a biomarker of stress
Time frame: 4-5 weeks
The effects of probiotic consumption on biomarkers of stress
1 secondary outcome
Changes in fecal microbiota populations
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 17 Oct 2018.
- Derived from this study: PubMed 35282787Cannavale CN, Mysonhimer AR, Bailey MA, Cohen NJ, Holscher HD, Khan NA. Consumption of a fermented dairy beverage improves hippocampal-dependent relational memory in a randomized, controlled cross-over trial. Nutr Neurosci. 2023 Mar;26(3):265-274. doi: 10.1080/1028415X.2022.2046963. Epub 2022 Mar 13.
- Individual participant dataSharing planned: Yes. Results will be disseminated by journal articles, thesis or academic papers, conference presentations, and sharing with the funding organization. No subject's identity will be disclosed in any presentation or released without their written permission.
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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, Ph.D. principal investigator
University of Illinois at Urbana-Champaign
Naiman Khan, Ph.D. principal investigator
University of Illinois at Urbana-Champaign
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 Probiotic Treatment in people with Physiological Stress and Cognition - Other, 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 17 Oct 2018. 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?
Changes in cortisol as a biomarker of stress (time frame: 4-5 weeks). 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 NCT02849275, 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 17 Oct 2018.