Cognitive DeclineNCT04643080
Dairy Based Probiotic Intervention and Cognitive, Emotional, and Inflammatory Outcomes
A study testing Yogurt in people with Cognitive Decline and Cognitive Change, run by University of Idaho at 4 sites in United States.
Trial summary
The purpose of this study was to determine the effect of dairy-based probiotics on cognitive function, emotional wellbeing, and inflammation. Subjects were assigned to either consume 6 oz of yogurt/day or abstain from consuming yogurt and other probiotic-containing foods for 12 weeks. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Decline, Cognitive Change, Inflammation
- What is being tested?
- Yogurt
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 4 sitesUnited States
- Study dates
- 7 Mar 2019to 15 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ability to participate in a 12-week study
- at least 50 years of age
- not currently taking a probiotic dietary supplement
- willing to refrain from consuming probiotic dietary supplements or fermented foods for 12-weeks
- willing to have blood drawn twice
- willing to consume yogurt daily for 12 weeks
Who cannot join
- -
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Idaho
Boise, Idaho, 83702
University of Idaho
Coeur d'Alene, Idaho, 83814
Kansas State University
Manhattan, Kansas, 66506
University of Idaho
Pocatello, Idaho, 83201
About this study
Official title: Effects of a 12-week Dairy-based Probiotic Dietary Intervention on Cognitive Performance, Emotional Well-being, and Inflammation in Older Adults
The purpose of this study was to determine the effect of dairy-based probiotics on cognitive function, emotional wellbeing, and inflammation. Subjects were assigned to either consume 6 oz of yogurt/day or abstain from consuming yogurt and other probiotic-containing foods for 12 weeks. Subjects completed baseline testing and 12-week follow-up testing consisting of a laboratory blood draw to assess inflammatory biomarkers, and a computerized assessment to evaluate cognitive and emotional wellbeing measures.
- Conditions
- Cognitive Decline, Cognitive Change, Inflammation, Emotions
- Being tested
- Yogurt
- Keywords
- Probiotics, Cognition, Emotional Wellbeing, Inflammation, Older Adults, Yogurt
- Medical subject headings
- Cognitive Dysfunction, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogurtOther
6 oz. of a commercially available yogurt were provided daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Subjects were asked to avoid consuming fermented foods for 12 weeks. |
| Yogurt | Experimental | Subjects were asked to consume 6 oz. of yogurt daily for 12 weeks. Receives: Other: Yogurt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fluid Cognition Composite from Baseline to 12-weeks
Subjects completed a battery of computerized cognitive assessments at baseline and 12-weeks, using the NIHToolbox for Assessment of Neurological and Behavioral Function application. The fluid cognition composite score was derived from scores on the Flanker Inhibitory Control and Attention Test, Dimensional Change Card Sort Test, Picture Sequence Memory Test, Pattern Comparison Processing Speed Test, and List Sorting Working Memory test.
Measured: Change from baseline fluid cognition composite score at 12-weeks
Change in Executive Function from Baseline to 12-weeks
Subjects completed a battery of computerized cognitive assessments at baseline and 12-weeks, using the NIHToolbox for Assessment of Neurological and Behavioral Function application. Executive function was assessed by the Flanker Inhibitory Control and Attention Test and the Dimensional Change Card Sort Test.
Measured: Change from baseline executive function test scores at 12 weeks
Change in Attention from Baseline to 12-weeks
Subjects completed a battery of computerized cognitive assessments at baseline and 12-weeks, using the NIHToolbox for Assessment of Neurological and Behavioral Function application. Attention was assessed by the Flanker Inhibitory Control and Attention Test.
Measured: Change from baseline attention test scores at 12 weeks
Change in Working Memory from Baseline to 12-weeks
Subjects completed a battery of computerized cognitive assessments at baseline and 12-weeks, using the NIHToolbox for Assessment of Neurological and Behavioral Function application. Working Memory was assessed by the List Sorting Working Memory test.
Measured: Change from baseline working memory test scores at 12 weeks
Change in Processing Speed from Baseline to 12-weeks
Subjects completed a battery of computerized cognitive assessments at baseline and 12-weeks, using the NIHToolbox for Assessment of Neurological and Behavioral Function application. Processing Speed was assessed by the Pattern Comparison Processing Speed test.
Measured: Change from baseline processing speed test scores at 12 weeks
Change in Episodic Memory from Baseline to 12-weeks
Subjects completed a battery of computerized cognitive assessments at baseline and 12-weeks, using the NIHToolbox for Assessment of Neurological and Behavioral Function application. Episodic Memory was assessed by the Picture Sequence Memory test.
Measured: Change in baseline episodic memory score at 12 weeks
Secondary outcomes (6)
Change in Negative Affect from Baseline to 12-weeks
Subjects completed a battery of computerized self-reported questionnaires using the NIHToolbox for Assessment of Neurological and Behavioral Function. A Negative Affect summary score was derived from 5 individual assessments of anger affect, anger hostility, sadness, fear affect, and perceived stress.
Measured: Change from baseline negative affect test scores at 12 weeks
Change in Psychological Wellbeing
Subjects completed a battery of computerized self-reported questionnaires using the NIHToolbox for Assessment of Neurological and Behavioral Function. A Psychological Wellbeing summary score was derived from 3 individual assessments of life satisfaction, meaning, and positive affect.
Measured: Change from baseline psychological satisfaction test scores at 12 weeks
Change in Social Satisfaction from Baseline to 12-weeks
Subjects completed a battery of computerized self-reported questionnaires using the NIHToolbox for Assessment of Neurological and Behavioral Function. A Social Satisfaction summary score was derived from 5 individual assessments of friendship, loneliness, emotional support, instrumental support, and perceived rejection.
Measured: Change from baseline social satisfaction test scores at 12 weeks
Change in serum interleukin-6 concentration from baseline to 12 weeks
Serum samples were analyzed to determine concentrations of interleukin-6 (pg/mL).
Measured: Change from baseline serum interleukin-6 concentration at 12 weeks
Change in serum tumor necrosis factor-alpha concentration from baseline to 12 weeks
Serum samples were analyzed to determine concentrations of tumor necrosis factor-alpha (pg/mL).
Measured: Change from baseline serum tumor necrosis factor-alpha concentration at 12 weeks
Change in serum c-reactive protein concentration from baseline to 12 weeks
Serum samples were analyzed to determine concentrations of c-reactive protein (mg/L).
Measured: Change from baseline serum c-reactive protein concentration at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start7 Mar 2019
- Primary completion15 Jul 2019
- Study completion15 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DeclineStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Idaho
- Sponsor type
- University, hospital or other
- Collaborators
- Kansas State University
- Responsible party
- Principal investigator, Annie Roe, University of Idaho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04643080
- Sponsor's protocol ID
- 18-203
- Status last verified
- Nov 2020
- First submitted
- 16 Nov 2020
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a small pilot study and there are not intentions to make individual participant data available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a 12-week Dairy-based Probiotic Dietary Intervention on Cognitive Performance, Emotional Well-being, and Inflammation in Older Adults
- ClinicalTrials.gov ID
- NCT04643080
- Acronym / sponsor ID
- 18-203
- Conditions
- Cognitive Decline, Cognitive Change, Inflammation, Emotions
- Keywords
- Probiotics, Cognition, Emotional Wellbeing, Inflammation, Older Adults, Yogurt
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of IdahoUniversity, hospital or other
- Collaborators
- Kansas State University
- Study start
- 7 Mar 2019 (actual)
- Primary completion
- 15 Jul 2019 (actual)
- Study completion
- 15 Jul 2019 (actual)
- First posted
- 24 Nov 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.
The purpose of this study was to determine the effect of dairy-based probiotics on cognitive function, emotional wellbeing, and inflammation. Subjects were assigned to either consume 6 oz of yogurt/day or abstain from consuming yogurt and other probiotic-containing foods for 12 weeks. Subjects completed baseline testing and 12-week follow-up testing consisting of a laboratory blood draw to assess inflammatory biomarkers, and a computerized assessment to evaluate cognitive and emotional wellbeing measures.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Subjects were asked to avoid consuming fermented foods for 12 weeks. |
| Yogurt | Experimental | Other: YogurtSubjects were asked to consume 6 oz. of yogurt daily for 12 weeks. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ability to participate in a 12-week study
- at least 50 years of age
- not currently taking a probiotic dietary supplement
- willing to refrain from consuming probiotic dietary supplements or fermented foods for 12-weeks
- willing to have blood drawn twice
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Yogurt6 oz. of a commercially available yogurt were provided daily for 12 weeks | Other | Yogurt |
Primary outcome
Change in Fluid Cognition Composite from Baseline to 12-weeks
Time frame: Change from baseline fluid cognition composite score at 12-weeks
Subjects completed a battery of computerized cognitive assessments at baseline and 12-weeks, using the NIHToolbox for Assessment of Neurological and Behavioral Function application. The fluid cognition composite score was derived from scores on the Flanker Inhibitory Control and Attention Test, Dimensional Change Card Sort Test, Picture Sequence Memory Test, Pattern Comparison Processing Speed Test, and List Sorting Working Memory test.
Change in Executive Function from Baseline to 12-weeks
Time frame: Change from baseline executive function test scores at 12 weeks
Subjects completed a battery of computerized cognitive assessments at baseline and 12-weeks, using the NIHToolbox for Assessment of Neurological and Behavioral Function application. Executive function was assessed by the Flanker Inhibitory Control and Attention Test and the Dimensional Change Card Sort Test.
Change in Attention from Baseline to 12-weeks
Time frame: Change from baseline attention test scores at 12 weeks
Subjects completed a battery of computerized cognitive assessments at baseline and 12-weeks, using the NIHToolbox for Assessment of Neurological and Behavioral Function application. Attention was assessed by the Flanker Inhibitory Control and Attention Test.
Change in Working Memory from Baseline to 12-weeks
Time frame: Change from baseline working memory test scores at 12 weeks
Subjects completed a battery of computerized cognitive assessments at baseline and 12-weeks, using the NIHToolbox for Assessment of Neurological and Behavioral Function application. Working Memory was assessed by the List Sorting Working Memory test.
Change in Processing Speed from Baseline to 12-weeks
Time frame: Change from baseline processing speed test scores at 12 weeks
Subjects completed a battery of computerized cognitive assessments at baseline and 12-weeks, using the NIHToolbox for Assessment of Neurological and Behavioral Function application. Processing Speed was assessed by the Pattern Comparison Processing Speed test.
Change in Episodic Memory from Baseline to 12-weeks
Time frame: Change in baseline episodic memory score at 12 weeks
Subjects completed a battery of computerized cognitive assessments at baseline and 12-weeks, using the NIHToolbox for Assessment of Neurological and Behavioral Function application. Episodic Memory was assessed by the Picture Sequence Memory test.
6 secondary outcomes
Change in Negative Affect from Baseline to 12-weeks
Time frame: Change from baseline negative affect test scores at 12 weeks
Change in Psychological Wellbeing
Time frame: Change from baseline psychological satisfaction test scores at 12 weeks
Change in Social Satisfaction from Baseline to 12-weeks
Time frame: Change from baseline social satisfaction test scores at 12 weeks
Change in serum interleukin-6 concentration from baseline to 12 weeks
Time frame: Change from baseline serum interleukin-6 concentration at 12 weeks
Change in serum tumor necrosis factor-alpha concentration from baseline to 12 weeks
Time frame: Change from baseline serum tumor necrosis factor-alpha concentration at 12 weeks
Change in serum c-reactive protein concentration from baseline to 12 weeks
Time frame: Change from baseline serum c-reactive protein concentration at 12 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 24 Nov 2020.
- Individual participant dataSharing planned: No. This is a small pilot study and there are not intentions to make individual participant data available to other researchers.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yogurt in people with Cognitive Decline and Cognitive Change, run by University of Idaho at 4 sites 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 6 inclusion and 1 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 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. 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 Fluid Cognition Composite from Baseline to 12-weeks (time frame: Change from baseline fluid cognition composite score at 12-weeks). The study lists 6 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 24 Nov 2020.