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

Not Applicable

Completed

• Conditions: Gastrointestinal Function; Intestinal Permeability
• Interventions: Other: Control Beverage; Other: Cranberry Beverage

• Registration Number: NCT03957239
• Lead Sponsor: University of Florida

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-05-17
• Study First Submitted QC: 2019-05-17
• Study First Posted: 2019-05-21
• Study Start: 2019-09-05
• Status Verified: 2020-01
• Primary Completion: 2020-01-02
• Study Completion: 2020-01-02
• Last Update Submitted: 2020-01-06
• Last Update Posted: 2020-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo Group	Control Beverage	Four prepackaged juice boxes (4.23 oz each) containing a cranberry-flavored beverage for 2 weeks
Cranberry Beverage	Cranberry Beverage	Four prepackaged juice boxes (4.23 oz each) containing a whole milled cranberry beverage for 2 weeks

Primary Outcome Measures

Name	Time	Method
Change in Gastroduodenal permeability	Baseline and Week 2 of each intervention	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.

Secondary Outcome Measures

Name	Time	Method
Change in Colonic permeability	Baseline and Week 2 of each intervention	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
Change in Whole gut permeability	Baseline and Week 2 of each intervention	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
Change in Stool consistency	Baseline and Week 2 of each intervention	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.
Change in Stool frequency	Baseline and Week 2 of each intervention	Compare the number of number of stools between the cranberry beverage versus control beverage
Change in Small intestinal permeability	Baseline and Week 2 of each intervention	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
Change in Bacterial species of interest	Baseline and Week 2 of each intervention	Compare the genome equivalents between the cranberry beverage versus control beverage. Genome equivalents will be measured by quantitative polymerase chain reaction.

Trial Locations

Locations (1)

UF Health at the University of Florida; 🇺🇸 Gainesville, Florida, United States