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| ID | Type | Description | Link |
|---|---|---|---|
| OCR21702 | Other Identifier | UF OnCore |
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| Name | Class |
|---|---|
| Ocean Spray, Inc. | INDUSTRY |
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In this double blind, crossover study participants will consume a cranberry beverage and a cranberry-flavored beverage for 2 weeks each. Gut permeability will be assessed weekly using aspirin and food-grade sugar molecules. Participants will be asked to provide urine, blood, saliva and stool samples to assess gut permeability and microbial communities. No change in permeability to the small sugar probes is anticipated with the cranberry beverage
Obesity, stress, liver disease, alcoholism, diabetes, and autoimmune diseases in humans or animal models are associated with altered intestinal permeability; consequently, maintenance of the gastrointestinal barrier is an emerging area of interest. The purpose of this randomized, double-blind, controlled crossover study is to compare the difference between the change from baseline in gastroduodenal permeability after drinking a cranberry or control beverage for two weeks. Gastroduodenal permeability will be assessed following aspirin challenge by measuring urinary sucrose in the 0 to 5-hour urine collection after differential sugar probes are consumed. Urine will be collected for an additional 19 hours (24 hours total) to assess whole gut permeability. A 4-week washout period will separate the interventions. Stool and fasting blood and saliva samples will be obtained before and during the intervention periods to assess fecal microbial communities and markers of intestinal barrier, immune function and oxidative stress. It is anticipated that cranberry juice will selectively increase intestinal Akkermansia bacteria, reduce markers of inflammation and oxidative stress, increase mucosal immunity, and protect the gastroduodenal barrier from an aspirin challenge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cranberry Beverage | Experimental | Four prepackaged juice boxes (4.23 oz each) containing a whole milled cranberry beverage for 2 weeks |
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| Placebo Group | Placebo Comparator | Four prepackaged juice boxes (4.23 oz each) containing a cranberry-flavored beverage for 2 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cranberry Beverage | Other | The cranberry beverage will provide 50 kcals and 4.0 grams of fiber per day from whole milled cranberries, water, cranberry natural flavor and sucralose. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Gastroduodenal permeability | Compare the statistical difference between the change from baseline (i.e., final - baseline) in gastroduodenal permeability after consuming the cranberry beverage for 2 weeks versus the change after consuming the control beverage for 2 weeks. Gastroduodenal permeability will be assessed following aspirin challenge by measuring urinary sucrose in the 0 to 5-hour urine collection. | Baseline and Week 2 of each intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Small intestinal permeability | Compare the difference between the changes in lactulose/rhamnose concentrations in a 5-hour urine collection (end of intervention minus baseline) from the cranberry beverage versus control beverage | Baseline and Week 2 of each intervention |
| Change in Colonic permeability |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Bobbi Langkamp-Henken, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UF Health at the University of Florida | Gainesville | Florida | 32610 | United States |
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A randomized, double-blind, placebo-controlled crossover in which participants receive one of the study beverages (cranberry or cranberry-flavored) for a 2-week intervention period each will be used.
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The participants, investigators, and anyone else involved with the study will remain blinded for its entirety.
| Control Beverage | Other | The control beverage will provide 50 kcals per day and is a color, taste matched sugar sweetened beverage formulated with water, sucrose, citric acid, cranberry natural flavor, malic acid, xanthum gum, sucralose and artificial color (red 40, blue 1). |
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Compare the difference between the changes in sucralose/ erythritol ratio in the 5 to 24-hour urine collection (end of intervention minus baseline) from the cranberry beverage vs control beverage |
| Baseline and Week 2 of each intervention |
| Change in Whole gut permeability | Compare the difference between the changes in sucralose/ erythritol ratio in the 0 to 24-hour urine collection (end of intervention minus baseline) from the cranberry beverage vs control beverage | Baseline and Week 2 of each intervention |
| Change in Stool consistency | Compare the average stool consistency (Bristol Stool Form Scale) between the cranberry beverage versus control beverage. The Bristol Stool Form Scale (BSS) measures stool types from 1-7 with 1 = hard and 7 = liquid. A score from 3-5 is indicative of a normal BSS. | Baseline and Week 2 of each intervention |
| Change in Stool frequency | Compare the number of number of stools between the cranberry beverage versus control beverage | Baseline and Week 2 of each intervention |
| Change in Bacterial species of interest | Compare the genome equivalents between the cranberry beverage versus control beverage. Genome equivalents will be measured by quantitative polymerase chain reaction. | Baseline and Week 2 of each intervention |