Gastric pH and Anthocyanin Absorption

Overview

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.

Full Title of Study: “Gastric pH as a Possible Determinant of Anthocyanin Absorption”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2010

Interventions

  • Drug: omeprazole
    • omeprazole 20.6 mg tablet with berries (blackberries + strawberries)
  • Drug: placebo
    • Placebo with berries (blackberries + strawberries)

Arms, Groups and Cohorts

  • Placebo Comparator: placebo
    • Placebo with berries (blackberries + strawberries)
  • Experimental: omeprazole
    • Prilosec (omeprazole) 20.6 mg tablet with berries (blackberries + strawberries)

Clinical Trial Outcome Measures

Primary Measures

  • Gastric pH
    • Time Frame: 1 hour prior to gastric emptying on Day 7 of the given intervention

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 22 Years

Maximum Age: 59 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • USDA Beltsville Human Nutrition Research Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Janet Novotny, Research Physiologist – USDA Beltsville Human Nutrition Research Center
  • Overall Official(s)
    • Beverly Clevidence, Ph. D., Principal Investigator, USDA Beltsville Human Nutrition Research Center

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