NCT01122160CompletedNot Applicable
Gastric pH as a Possible Determinant of Anthocyanin Absorption
USDA Beltsville Human Nutrition Research Center1 site in 1 country13 target enrollmentStarted: May 2010Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- Gastric pH
Study Overview
Brief Summary
Anthocyanins are phytonutrients that provide blue, purple and red colors to fruits and vegetables. The purpose of the study is to determine whether absorption of anthocyanins occurs in the acid pH of the stomach and to determine whether altering stomach pH by use of an over-the-counter medicine, Prilosec TM, alters absorption of anthocyanins from strawberries and blackberries.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 22 Years to 59 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •BMI 18.5 kg/m2 to 30 kg/m2
- •Age 22 to 59 years
Exclusion Criteria
- •Plans to have MRI analysis or other contact with MRI equipment during the study
- •Has implanted or portable electro-mechanical medical device such as a cardiac pacemaker or infusion pump
- •Suspected strictures, fistulas or physiological GI obstruction
- •Allergy to omeprazole
- •Current use of clopidogrel (Plavix) or use within the past 3 months
- •Use of warfarin, prescription antifungals/anti-yeast drugs, diazepam, and digoxin
- •Chronic daily use of nonsteroidal anti-inflammatory drugs (ibuprofen, naproxen, etc.)
- •History of bariatric or other gastric surgery
- •Frequent use of antacids
- •Use of proton pump inhibitors in past 3 months
- •History of acid reflux
- •History of gastrointestinal disorders or gastrointestinal surgery
- •History of bezoars (packed collection of partially digested or undigested material that is unable to exit the stomach)
- •Crohn's disease, diverticulitis or inflammatory bowel disease
- •Inability to swallow large pills
- •Dysphagia (Trouble or pain with swallowing food or pills)
- •Allergy to strawberries or blackberries
- •Pregnant women
- •Lactating women
- •Pregnancy in last 12 months
- •History of kidney disease
- •History of liver disease
- •History of metabolic disorder
- •History of some cancers
- •Tobacco use in past 6 months
- •Use of oral or IV antibiotics in past month
- •Use of herbal supplement in past month
Arms & Interventions
placebo
Placebo Comparator
Placebo with berries (blackberries + strawberries)
Intervention: placebo (Drug)
omeprazole
Experimental
Prilosec (omeprazole) 20.6 mg tablet with berries (blackberries + strawberries)
Intervention: omeprazole (Drug)
Outcomes
Primary Outcomes
Gastric pH
Time Frame: 1 hour prior to gastric emptying on Day 7 of the given intervention
Secondary Outcomes
No secondary outcomes reported
Investigators
Janet Novotny
Research Physiologist
USDA Beltsville Human Nutrition Research Center
Study Sites (1)
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