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| ID | Type | Description | Link |
|---|---|---|---|
| 236-2012 | Other Grant/Funding Number | Wakunaga of America Co., Ltd. |
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The purpose of this study is to determine whether healthy older adults, aged 65 to 80 years, consuming a probiotic each day for three weeks will have improved immune strength and digestive health. It is hypothesized that older adults consuming the probiotics will see a shift in their microbiota towards the "healthy" bacteria resulting in a greater proportion of immune cells, decreased inflammation, and better digestive health.
This is a randomized, double-blind, placebo controlled crossover design with two 3-week interventions and a 5-week washout period in between. Thirty-six participants will be enrolled. With informed consent, the daily questionnaire will be administered and a baseline stool sample will be obtained during the week before the start of each intervention period. Blood and saliva will be collected on the first and last day of each intervention period to assess immune function. A final stool sample will be obtained in the last week of the intervention period. Nutritional status, which can impact immune function, will be assessed using the Mini-Nutritional Assessment, Block Fiber Screen, and the Block 2005 Food Frequency Questionnaire. Daily questionnaires will record intake of the probiotic or placebo, level of stress, hours of sleep, visits to the physician, new medications, number of stools, etc. The Gastrointestinal Symptom Response Scale, which records gastrointestinal symptoms, such as bloating, gas, diarrhea, and constipation, over the past week will be completed at baseline and weekly during the interventions and the week following the interventions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Experimental | Capsules containing Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum |
|
| Placebo | Placebo Comparator | Capsules containing placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement | 2 capsules daily containing Lactobacillus gasseri, Bifidobacterium bifidum and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cytokine production | Peripheral blood mononuclear cell cytokine production following lipopolysaccharide stimulation | Measured at baseline and after 3 weeks of supplementation for each arm |
| Change in bacterial species measured in fecal samples |
| Measured at baseline and after 3 weeks of supplementation for each arm |
| Measure | Description | Time Frame |
|---|---|---|
| Change in digestive symptoms on the Gastrointestinal Symptom Response Scale | Symptoms (gas, bloating, diarrhea, etc.) reported on a daily questionnaire and a weekly Gastrointestinal Symptom Response Scale | Measured at baseline, weeks 1, 2, 3 and 4 of each arm |
| Change in Mucosal immune function |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bobbi Langkamp-Henken, PhD, RD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32611 | 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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| Placebo | Dietary Supplement | 2 capsules daily containing 348.25 mg of potato starch |
|
sIgA |
| Measured at baseline and after 3 weeks of supplementation for each arm |
| D019602 |
| Food and Beverages |