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| Name | Class |
|---|---|
| iHealth | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Experimental | Participants in this arm will receive probiotic supplementation for 12 weeks (Lactobacillus Rhamnosus GG) |
|
| Control | Placebo Comparator | Participants in this arm will receive placebo that look similar to probiotics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic - Lactobacillus Rhamnosus GG | Dietary Supplement | 2 capsules per day for 90 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in score on Center for Epidemiologic Studies Depression - R (CES-D-R) | Depressive symptoms | Baseline and 12 week follow up |
| Change in score on State-Trait Anxiety Inventory | Anxiety symptoms | Baseline and 12 week follow up |
| Change in score on Perceived Stress Scale | Subjective stress | Baseline and 12 week follow up |
| Change in score on Positive and Negative Affect Schedule | Fluctuations in affect | Baseline and 12 week follow up |
| Change in score on Profile of Mood States | Fluctuations in affect - acute | Baseline and 12 week follow up |
| Change in score on Warwick-Edinburgh Mental Well-Being Scale | Subjective wellbeing | Baseline and 12 week follow up |
| Change in score on OECD Life Satisfaction scale (short) | Subjective wellbeing - general | Baseline and 12 week follow up |
| Change in score on Response to Stressful Events Scale | Emotion regulation | Baseline and 12 week follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Picture Sequence Memory Test and Auditory Verbal Learning Test scores | Memory | Baseline and 12 week follow up |
| Change in Dimension Card Sort Test, Flanker Inhibitory Control, and List Sorting Working Memory Test scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Gunstad, Ph.D. | Kent State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kent State Uniersity | Kent | Ohio | 44242 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36228569 | Derived | 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. | |
| 35617704 | Derived | Sanborn 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. |
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| Placebo |
| Other |
2 placebo capsules per day for 90 days |
|
| Change in score on Connor-Davidson Resilience Scale | Emotional resilience | Baseline and 12 week follow up |
Executive function/Attention
| Baseline and 12 week follow up |
| Change in Pattern Comparison Processing Speed Test scores | Processing Speed | Baseline and 12 week follow up |
| Change in SF-36 scores | Quality of Life | Baseline and 12 week follow up |
| Change in Pittsburgh Sleep Quality Index scores | Sleep patterns | Baseline and 12 week follow up |
| Change in Gastrointestinal Symptom Rating Scale scores | Subjective gastrointestinal symptoms | Baseline and 12 week follow up |
| Change in HbA1c and fasting glucose values | Laboratory measures of glycemic control | Baseline and 12 week follow up |
| Change in C-reactive protein, Interleukin-6, and TNF-alpha values | Laboratory measures of inflammation | Baseline and 12 week follow up |
| Change in Total Cholesterol, HDL, LDL, and VLDL values | Laboratory meausres of lipid levels | Baseline and 12 week follow up |
| Change in waking cortisol levels | Laboratory measure of cortisol | Baseline and 12 week follow up |
| Change in composition of the gut microbiome | Laboratory measure of gut microbiome | Baseline and 12 week follow up |
| Change in oral microbiome composition | Laboratory measure of oral microbiome | Baseline and 12 week follow up |