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| Name | Class |
|---|---|
| MeriCal LLC | UNKNOWN |
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The purpose of this graduate student research study is to evaluate the efficacy of a multi-strain probiotic and investigate if sex differences influence the role of probiotics on stress and immunity biomarkers.
Visit #1
Participants will read and sign informed consent forms, HIPPA form, and SAHP Covid-19 screening form.
Participants will perform a baseline oral saliva swab to test for the stress biomarker cortisol and immune markers, including Interleukin-1β (IL-1β) and Tumor Necrosis Factor (TNF).
Participants will complete a Quality-of-Life Questionnaire (10-15 minutes).
As this study is double blinded, participants will be separated by gender (male and female) and will select a 90-day supply of placebo or probiotic sample at random. For each gender group there will be 50 samples to select from, comprised of a mix of 25 placebo and 25 probiotic bottles.
Participants will be instructed to take 1 capsule per day for the following 90 days. If a participant misses a day, they should resume taking 1 capsule per day the next day. The capsule should not be crushed or chewed. The capsule may be taken with or without food per participant preference. The participant should consistently take the probiotic at a similar time each day (example: always take it in the morning or evening) Visit #2
Participants will complete the same Quality-of-Life Questionnaire from visit #1
Participants will perform a post-study oral saliva swab in the same manner as visit #1
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Male Probiotic | Experimental | • Participants will be instructed to take 1 capsule per day for the following 90 days. If a participant misses a day, they should resume taking 1 capsule per day the next day. The capsule should not be crushed or chewed. The capsule may be taken with or without food per participant preference. The participant should consistently take the capsule at a similar time each day (example: always take it in the morning or evening) |
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| Male Placebo | Placebo Comparator | • Participants will be instructed to take 1 capsule per day for the following 90 days. If a participant misses a day, they should resume taking 1 capsule per day the next day. The capsule should not be crushed or chewed. The capsule may be taken with or without food per participant preference. The participant should consistently take the capsule at a similar time each day (example: always take it in the morning or evening) |
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| Female Probiotic | Experimental | • Participants will be instructed to take 1 capsule per day for the following 90 days. If a participant misses a day, they should resume taking 1 capsule per day the next day. The capsule should not be crushed or chewed. The capsule may be taken with or without food per participant preference. The participant should consistently take the capsule at a similar time each day (example: always take it in the morning or evening) |
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| Female Placebo | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement | The probiotic to be used in the study is in capsule form and consists of 12 bacterial strains and 10-billion colony forming unit (CFU). The product consists of the following bacterial strains and species: Bifidobacterium infantis ATCC SD 6720, Bifidobacterium bifidum ATCC SD 6576, Bifidobacterium breve ATCC SD 5206, Bifidobacterium lactis ATCC SD 5220, Bifidobacterium longum ATCC SD 5588, Lactobacillus acidophilus DSM 32754, Lactobacillus casei ATCC SD5213, Lactobacillus paracasei ATCC SD 5275, Lactobacillus plantarum ATCC SD 5209, Lactobacillus reuteri ATCC SD 6689, Lactobacillus rhamnosus ATCC 53103, Lactobacillus salivarius ATCC SD 5208) in combination with the prebiotic, xylooligosacharide (XOS). |
| Measure | Description | Time Frame |
|---|---|---|
| Saliva Sample Cortisol | Baseline and post-study oral saliva samples will be tested for the stress biomarker cortisol uL. | Change in cortisol uL between baseline and 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Saliva Sample IL-1 | Baseline and post-study oral saliva samples will be tested for Interleukin-1β (IL-1β) uL. | Change in Interleukin-1β (IL-1β) uL between baseline and 90 days |
| Saliva Sample Tumor Necrosis Factor |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| JeJe Noval, PhD | Loma Linda University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University | Loma Linda | California | 92350 | United States |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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• Participants will be instructed to take 1 capsule per day for the following 90 days. If a participant misses a day, they should resume taking 1 capsule per day the next day. The capsule should not be crushed or chewed. The capsule may be taken with or without food per participant preference. The participant should consistently take the capsule at a similar time each day (example: always take it in the morning or evening)
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| Placebo | Dietary Supplement | A placebo, that will be indistinguishable in appearance to the probiotic, will be provided to half of all study participants for the length of the trial. It will contain the following ingredients: Microcrystalline cellulose, magnesium stearate, a vegetarian capsule, and silicon dioxide. The probiotic will be manufactured by MeriCal. |
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Baseline and post-study oral saliva samples will be tested for Tumor Necrosis Factor (TNF) uL.
| Change in Tumor Necrosis Factor (TNF) uL between baseline and 90 days |
| D019602 |
| Food and Beverages |