Gastric pH and Anthocyanin Absorption

July 23, 2013 updated by: Janet Novotny, USDA Beltsville Human Nutrition Research Center

Gastric pH as a Possible Determinant of Anthocyanin Absorption

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Beltsville, Maryland, United States, 20705
        • USDA's Beltsville Human Nutrition Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 59 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: placebo
Placebo with berries (blackberries + strawberries)
Drug: placebo
Placebo with berries (blackberries + strawberries)
EXPERIMENTAL: omeprazole
Prilosec (omeprazole) 20.6 mg tablet with berries (blackberries + strawberries)
Drug: omeprazole
omeprazole 20.6 mg tablet with berries (blackberries + strawberries)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

USDA Beltsville Human Nutrition Research Center

Investigators

  • Principal Investigator: Beverly Clevidence, Ph. D., USDA Beltsville Human Nutrition Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (ACTUAL)

December 1, 2010

Study Completion (ACTUAL)

December 1, 2010

Study Registration Dates

First Submitted

May 10, 2010

First Submitted That Met QC Criteria

May 10, 2010

First Posted (ESTIMATE)

May 13, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

August 23, 2013

Last Update Submitted That Met QC Criteria

July 23, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-069

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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