Gastric pH and Anthocyanin Absorption

Beltsville Human Nutrition Research Center (BHNRC)

Status: Completed

Conditions: Anthocyanin Metabolism

Treatments: Drug: placebo; Drug: omeprazole

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01122160

2010-069

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 22 to 59 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

13 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

Placebo with berries (blackberries + strawberries)

Treatment:

Drug: placebo

omeprazole

Experimental group

Description:

Prilosec (omeprazole) 20.6 mg tablet with berries (blackberries + strawberries)

Treatment:

Drug: omeprazole