Gastric pH and Anthocyanin Absorption

Study Overview
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Brief Summary
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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.

Official Title
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Gastric pH as a Possible Determinant of Anthocyanin Absorption

Conditions
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Anthocyanin Metabolism

Intervention / Treatment
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* Drug: omeprazole
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>Placebo with berries (blackberries + strawberries) | Drug: placebo<br>* Placebo with berries (blackberries + strawberries)<br>|
| Experimental: omeprazole<br>Prilosec (omeprazole) 20.6 mg tablet with berries (blackberries + strawberries) | Drug: omeprazole<br>* omeprazole 20.6 mg tablet with berries (blackberries + strawberries)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric pH |  | 1 hour prior to gastric emptying on Day 7 of the given intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anthocyanin, omeprazole, Prilosec, gastric pH, proton pump inhibitor, PPI, nutrition