- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03957239
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
43
Phase
- 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
-
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Florida
-
Gainesville, Florida, United States, 32610
- UF Health at the University of Florida
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-
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
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 |
Intervention / Treatment |
---|---|
Experimental: Cranberry Beverage
Four prepackaged juice boxes (4.23 oz each) containing a whole milled cranberry beverage for 2 weeks
|
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
|
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
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
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
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Baseline and Week 2 of each intervention
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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
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Baseline and Week 2 of each intervention
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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
Collaborators
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)
September 5, 2019
Primary Completion (Actual)
January 2, 2020
Study Completion (Actual)
January 2, 2020
Study Registration Dates
First Submitted
May 17, 2019
First Submitted That Met QC Criteria
May 17, 2019
First Posted (Actual)
May 21, 2019
Study Record Updates
Last Update Posted (Actual)
January 7, 2020
Last Update Submitted That Met QC Criteria
January 6, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Other Study ID 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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