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

NCT03957239 | Completed

• 2 other identifiers: IRB201901253OCR21702
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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

Conditions

Intestinal Permeability; Gastrointestinal Function

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Change in Small intestinal permeability

  Baseline and Week 2 of each intervention

• Change in Colonic permeability

  Baseline and Week 2 of each intervention

• Change in Whole gut permeability

  Baseline and Week 2 of each intervention

• Change in Stool consistency

  Baseline and Week 2 of each intervention

• Change in Stool frequency

  Baseline and Week 2 of each intervention

Study Arms (2)

Cranberry Beverage

EXPERIMENTAL

Four prepackaged juice boxes (4.23 oz each) containing a whole milled cranberry beverage for 2 weeks

Other: Cranberry Beverage

Placebo Group

PLACEBO COMPARATOR

Four prepackaged juice boxes (4.23 oz each) containing a cranberry-flavored beverage for 2 weeks

Other: Control Beverage

Interventions

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.

Cranberry Beverage

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).

Placebo Group

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead
• Ocean Spray, Inc.: collaborator

Study Sites (1)

UF Health at the University of Florida

Gainesville, Florida, 32610, United States

Location

Study Officials

• Bobbi Langkamp-Henken, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participants, investigators, and anyone else involved with the study will remain blinded for its entirety.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: May 21, 2019
• Study Start: September 5, 2019
• Primary Completion: January 2, 2020
• Study Completion: January 2, 2020
• Last Updated: January 7, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)