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

January 6, 2020 updated by: University of Florida

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
43

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • UF Health at the University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Have a BMI ≥ 30 kg/m2 and a waist circumference ≥ 35 inches for women and ≥ 40 inches for men.
  • Have had a stable weight for 3 months (<5 kg or ~11 lbs body weight change)
  • Willing to discontinue the use of non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, aspirin, naproxen, or indomethacin, for the full length of the study.
  • Willing to discontinue consumption of wine and berries throughout the 12-week study.
  • Willing and able to avoid consumption of any cranberry juice, whole cranberries, and dried cranberries during the two weeks leading up to the study and during the study, not including the study beverage.
  • Willing to avoid beer and cocktails on the day before and the day of the sugar probe tests.
  • Willing to avoid the use of antidiarrheal or laxative medication on a regular or an "as-needed basis" during the full length of the study.
  • Willing to provide urine, saliva, blood, and stool samples during the study collection periods.
  • Have used aspirin in the past and did not experience adverse effects.
  • Willing to consume three tablets (325 mg each or 975 mg total) twice within a 9 to 12-hour period. This challenge will be repeated four times during the 12-week study.
  • Willing and able to complete daily and weekly questionnaires online regarding dietary intake and general health and well-being, including gastrointestinal habits.
  • Willing to discontinue consumption of fermented foods or probiotics.
  • Willing to discontinue consumption of fiber supplements.
  • Willing to discontinue taking prebiotic, herbal, or high-dose vitamin or mineral supplements that may impact immune function or inflammation during the pre-baseline period and throughout the study protocol.
  • Willing and able to consume 4.23 oz of a cranberry beverage four times daily (~16 oz total/d) for the 2-week study interventions.
  • Willing to avoid high intensity exercises two days prior to and the day of the permeability tests. These tests will be done on four occasions.
  • Willing and able to complete the informed consent form in English.
  • Willing to provide a social security number to receive study payment.

Exclusion Criteria

  • Currently being treated for a physician-diagnosed gastrointestinal disease or condition (such as ulcerative colitis, Crohn's disease, gastroparesis, cancer, peptic ulcer disease, Celiac disease, short bowel disease, ileostomy, or colostomy) other than GERD or diverticular disease
  • Currently being treated for or type 1 diabetes or type 2 diabetes by medication
  • Daily use of NSAIDs in the last 3 months or incidental use in the last 2 weeks prior to screening.
  • Allergy to aspirin or cranberries.
  • Participate in moderate or high exercise activities during a typical week.
  • Currently smoking (including vaping) tobacco products
  • Women who are lactating, pregnant, or are attempting to get pregnant.
  • Use of another investigational product within 3 months of the screening visit.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cranberry Beverage
Four prepackaged juice boxes (4.23 oz each) containing a whole milled cranberry beverage for 2 weeks
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.
Placebo Comparator: Placebo Group
Four prepackaged juice boxes (4.23 oz each) containing a cranberry-flavored beverage for 2 weeks
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Gastroduodenal permeability
Time Frame: 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.
Baseline and Week 2 of each intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Small intestinal permeability
Time Frame: 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
Baseline and Week 2 of each intervention
Change in Colonic permeability
Time Frame: 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
Baseline and Week 2 of each intervention
Change in Whole gut permeability
Time Frame: 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
Baseline and Week 2 of each intervention
Change in Stool consistency
Time Frame: 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.
Baseline and Week 2 of each intervention
Change in Stool frequency
Time Frame: Baseline and Week 2 of each intervention
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
Time Frame: 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.
Baseline and Week 2 of each intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Florida

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ocean Spray, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 5, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 2, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 2, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 17, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 21, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 7, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB201901253
  • OCR21702 (Other Identifier: UF OnCore)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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