Gastric pH and Anthocyanin Absorption

Not Applicable

Completed

• Conditions: Anthocyanin Metabolism
• Interventions: Drug: placebo; Drug: omeprazole

• Registration Number: NCT01122160
• Lead Sponsor: USDA Beltsville Human Nutrition Research Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-10
• Study First Submitted QC: 2010-05-10
• Study First Posted: 2010-05-13
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Results First Submitted: 2012-12-17
• Status Verified: 2013-07
• Results First Submitted QC: 2013-07-23
• Last Update Submitted: 2013-07-23
• Results First Posted: 2013-08-23
• Last Update Posted: 2013-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
placebo	placebo	Placebo with berries (blackberries + strawberries)
omeprazole	omeprazole	Prilosec (omeprazole) 20.6 mg tablet with berries (blackberries + strawberries)

Primary Outcome Measures

Name	Time	Method
Gastric pH	1 hour prior to gastric emptying on Day 7 of the given intervention

Trial Locations

Locations (1)

USDA's Beltsville Human Nutrition Research Center; 🇺🇸 Beltsville, Maryland, United States