NCT03957239

The Effect of a Cranberry Beverage on Intestinal Permeability and Gastrointestinal Function in Generally Healthy Adults

The Effect of a Cranberry Beverage on Intestinal Permeability and Gastrointestinal Function in Generally Healthy Adults With a BMI ≥ 30: a Randomized, Double-blind, Controlled, Crossover Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 21 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Intestinal Permeability
• Gastrointestinal Function

Interventions

Type	Name	Description
OTHER	Cranberry Beverage	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.
OTHER	Control Beverage	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).

Timeline

• Start date: 2019-09-05
• Primary completion: 2020-01-02
• Completion: 2020-01-02
• First posted: 2019-05-21
• Last updated: 2020-01-07

Locations

1 site across 1 country: United States