AgingNCT03080818
Probiotic on Psychological and Cognitive Effects
A study testing Probiotic - Lactobacillus Rhamnosus GG in people with Aging, run by Kent State University at 1 site in United States.
Trial summary
This study will determine whether supplementation of probiotic Lactobacillus Rhamnosus GG improves psychological status in middle age and older adults through a 12-week, randomized, double-blind, placebo-controlled clinical trial. Read more about this study
- Who is it for?
- Ages 55 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Probiotic - Lactobacillus Rhamnosus GG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 1 Jul 2019
- 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 55 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 55-75 years
- Able to speak and read English
Who cannot join
- History of neurological, developmental, or severe psychiatric disorder (e.g. dementia, stroke, schizophrenia);
- Antibiotic use in the past 30 days;
- History of significant stomach or GI surgery (e.g. gastric bypass, cholecystectomy);
- History of alcohol or illicit drug dependence;
- History of severe heart, kidney, or liver problems (e.g. heart failure, liver failure);
- Regular use of an acid-blocking medication in the past 30 days (i.e. proton pump inhibitor, H2 blocker);
Show all 9Show fewer
- Likely immunosuppression (e.g. chemotherapy treatment);
- Regular use of other pre- or probiotic supplements in the past 30 days;
- Severe gastrointestinal conditions including celiac disease, Crohn's disease, or diverticulitis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Probiotic on Psychological and Cognitive Effects in Middle and Older Adults
This study will determine whether supplementation of probiotic Lactobacillus Rhamnosus GG improves psychological status in middle age and older adults through a 12-week, randomized, double-blind, placebo-controlled clinical trial. Secondary analyses will be conducted to examine the possible benefits of probiotic supplementation on cognitive function and markers of physical health.
- Conditions
- Aging
- Being tested
- Probiotic - Lactobacillus Rhamnosus GG, Placebo
- Keywords
- Probiotic, Cognitive Function, Mood
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic - Lactobacillus Rhamnosus GGDietary supplement
2 capsules per day for 90 days
PlaceboOther
2 placebo capsules per day for 90 days
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Participants in this arm will receive probiotic supplementation for 12 weeks (Lactobacillus Rhamnosus GG) Receives: Dietary Supplement: Probiotic - Lactobacillus Rhamnosus GG |
| Control | Placebo comparator | Participants in this arm will receive placebo that look similar to probiotics Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in score on Center for Epidemiologic Studies Depression - R (CES-D-R)
Depressive symptoms
Measured: Baseline and 12 week follow up
Change in score on State-Trait Anxiety Inventory
Anxiety symptoms
Measured: Baseline and 12 week follow up
Change in score on Perceived Stress Scale
Subjective stress
Measured: Baseline and 12 week follow up
Change in score on Positive and Negative Affect Schedule
Fluctuations in affect
Measured: Baseline and 12 week follow up
Change in score on Profile of Mood States
Fluctuations in affect - acute
Measured: Baseline and 12 week follow up
Change in score on Warwick-Edinburgh Mental Well-Being Scale
Subjective wellbeing
Measured: Baseline and 12 week follow up
Change in score on OECD Life Satisfaction scale (short)
Subjective wellbeing - general
Measured: Baseline and 12 week follow up
Change in score on Response to Stressful Events Scale
Emotion regulation
Measured: Baseline and 12 week follow up
Change in score on Connor-Davidson Resilience Scale
Emotional resilience
Measured: Baseline and 12 week follow up
Secondary outcomes (12)
Change in Picture Sequence Memory Test and Auditory Verbal Learning Test scores
Memory
Measured: Baseline and 12 week follow up
Change in Dimension Card Sort Test, Flanker Inhibitory Control, and List Sorting Working Memory Test scores
Executive function/Attention
Measured: Baseline and 12 week follow up
Change in Pattern Comparison Processing Speed Test scores
Processing Speed
Measured: Baseline and 12 week follow up
Change in SF-36 scores
Quality of Life
Measured: Baseline and 12 week follow up
Change in Pittsburgh Sleep Quality Index scores
Sleep patterns
Measured: Baseline and 12 week follow up
Change in Gastrointestinal Symptom Rating Scale scores
Subjective gastrointestinal symptoms
Measured: Baseline and 12 week follow up
Change in HbA1c and fasting glucose values
Laboratory measures of glycemic control
Measured: Baseline and 12 week follow up
Change in C-reactive protein, Interleukin-6, and TNF-alpha values
Laboratory measures of inflammation
Measured: Baseline and 12 week follow up
Change in Total Cholesterol, HDL, LDL, and VLDL values
Laboratory meausres of lipid levels
Measured: Baseline and 12 week follow up
Change in waking cortisol levels
Laboratory measure of cortisol
Measured: Baseline and 12 week follow up
Change in composition of the gut microbiome
Laboratory measure of gut microbiome
Measured: Baseline and 12 week follow up
Change in oral microbiome composition
Laboratory measure of oral microbiome
Measured: Baseline and 12 week follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study start1 Feb 2017
- Primary completion1 Jan 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AgingStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kent State University
- Sponsor type
- University, hospital or other
- Collaborators
- iHealth
- Responsible party
- Principal investigator, John Gunstad, Kent State University
- Investigators
- John Gunstad, Ph.D., Principal investigator, Kent State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03080818
- Sponsor's protocol ID
- Kent State University
- Status last verified
- Feb 2020
- First submitted
- 5 Mar 2017
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aljumaah MR, Bhatia U, Roach J, Gunstad J, Azcarate Peril MA. The gut microbiome, mild cognitive impairment, and probiotics: A randomized clinical trial in middle-aged and older adults. Clin Nutr. 2022 Nov;41(11):2565-2576. doi: 10.1016/j.clnu.2022.09.012. Epub 2022 Sep 28.
PubMed 36228569Sanborn V, Aljumaah M, Azcarate-Peril MA, Gunstad J. Examining the cognitive benefits of probiotic supplementation in physically active older adults: A randomized clinical trial. Appl Physiol Nutr Metab. 2022 Aug 1;47(8):871-882. doi: 10.1139/apnm-2021-0557. Epub 2022 May 26.
PubMed 35617704
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Probiotic on Psychological and Cognitive Effects in Middle and Older Adults
- ClinicalTrials.gov ID
- NCT03080818
- Acronym / sponsor ID
- Kent State University
- Conditions
- Aging
- Keywords
- Probiotic, Cognitive Function, Mood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Kent State UniversityUniversity, hospital or other
- Collaborators
- iHealth
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 15 Mar 2017 (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 will determine whether supplementation of probiotic Lactobacillus Rhamnosus GG improves psychological status in middle age and older adults through a 12-week, randomized, double-blind, placebo-controlled clinical trial. Secondary analyses will be conducted to examine the possible benefits of probiotic supplementation on cognitive function and markers of physical health.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: Probiotic - Lactobacillus Rhamnosus GGParticipants in this arm will receive probiotic supplementation for 12 weeks (Lactobacillus Rhamnosus GG) |
| Control | Placebo comparator | Other: PlaceboParticipants in this arm will receive placebo that look similar to probiotics |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 55-75 years
- Able to speak and read English
Key exclusion criteria (9 listed)
- History of neurological, developmental, or severe psychiatric disorder (e.g. dementia, stroke, schizophrenia);
- Antibiotic use in the past 30 days;
- History of significant stomach or GI surgery (e.g. gastric bypass, cholecystectomy);
- History of alcohol or illicit drug dependence;
- History of severe heart, kidney, or liver problems (e.g. heart failure, liver failure);
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 |
|---|---|---|
| Probiotic - Lactobacillus Rhamnosus GG2 capsules per day for 90 days | Dietary supplement | Probiotic |
| Placebo2 placebo capsules per day for 90 days | Other | Control |
Primary outcome
Change in score on Center for Epidemiologic Studies Depression - R (CES-D-R)
Time frame: Baseline and 12 week follow up
Depressive symptoms
Change in score on State-Trait Anxiety Inventory
Time frame: Baseline and 12 week follow up
Anxiety symptoms
Change in score on Perceived Stress Scale
Time frame: Baseline and 12 week follow up
Subjective stress
Change in score on Positive and Negative Affect Schedule
Time frame: Baseline and 12 week follow up
Fluctuations in affect
Change in score on Profile of Mood States
Time frame: Baseline and 12 week follow up
Fluctuations in affect - acute
Change in score on Warwick-Edinburgh Mental Well-Being Scale
Time frame: Baseline and 12 week follow up
Subjective wellbeing
Change in score on OECD Life Satisfaction scale (short)
Time frame: Baseline and 12 week follow up
Subjective wellbeing - general
Change in score on Response to Stressful Events Scale
Time frame: Baseline and 12 week follow up
Emotion regulation
Change in score on Connor-Davidson Resilience Scale
Time frame: Baseline and 12 week follow up
Emotional resilience
12 secondary outcomes
Change in Picture Sequence Memory Test and Auditory Verbal Learning Test scores
Time frame: Baseline and 12 week follow up
Change in Dimension Card Sort Test, Flanker Inhibitory Control, and List Sorting Working Memory Test scores
Time frame: Baseline and 12 week follow up
Change in Pattern Comparison Processing Speed Test scores
Time frame: Baseline and 12 week follow up
Change in SF-36 scores
Time frame: Baseline and 12 week follow up
Change in Pittsburgh Sleep Quality Index scores
Time frame: Baseline and 12 week follow up
Change in Gastrointestinal Symptom Rating Scale scores
Time frame: Baseline and 12 week follow up
Change in HbA1c and fasting glucose values
Time frame: Baseline and 12 week follow up
Change in C-reactive protein, Interleukin-6, and TNF-alpha values
Time frame: Baseline and 12 week follow up
Change in Total Cholesterol, HDL, LDL, and VLDL values
Time frame: Baseline and 12 week follow up
Change in waking cortisol levels
Time frame: Baseline and 12 week follow up
Change in composition of the gut microbiome
Time frame: Baseline and 12 week follow up
Change in oral microbiome composition
Time frame: Baseline and 12 week follow up
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 20 Feb 2020.
- Derived from this study: PubMed 36228569Aljumaah MR, Bhatia U, Roach J, Gunstad J, Azcarate Peril MA. The gut microbiome, mild cognitive impairment, and probiotics: A randomized clinical trial in middle-aged and older adults. Clin Nutr. 2022 Nov;41(11):2565-2576. doi: 10.1016/j.clnu.2022.09.012. Epub 2022 Sep 28.
- Derived from this study: PubMed 35617704Sanborn V, Aljumaah M, Azcarate-Peril MA, Gunstad J. Examining the cognitive benefits of probiotic supplementation in physically active older adults: A randomized clinical trial. Appl Physiol Nutr Metab. 2022 Aug 1;47(8):871-882. doi: 10.1139/apnm-2021-0557. Epub 2022 May 26.
- Individual participant dataSharing planned: No
Related trials for Aging
Enrolling by invitationPhase 2
Tirzepatide and Organ-specific Biological Aging
Longevity, Preventive Medicine
Active, not recruiting
Emotional Well-being and Measures of Healthy Aging
Aging, Aging, Healthy
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Active, not recruiting
Vascular Aging and Lp299v Study in Healthy Adults
Vascular Aging
RecruitingObservational study
Amyloid PET Imaging in the Baltimore Longitudinal Study of Aging
Aging
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.
John Gunstad, Ph.D. principal investigator
Kent State 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 Probiotic - Lactobacillus Rhamnosus GG in people with Aging, run by Kent State 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 2 inclusion and 9 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 20 Feb 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?
Change in score on Center for Epidemiologic Studies Depression - R (CES-D-R) (time frame: Baseline and 12 week follow up). The study lists 9 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 NCT03080818, which also lists 2 linked publications.
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 20 Feb 2020.