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Gastric pH and Anthocyanin Absorption

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01122160
Recruitment Status : Completed
First Posted : May 13, 2010
Results First Posted : August 23, 2013
Last Update Posted : August 23, 2013
Sponsor:
Information provided by (Responsible Party):
Janet Novotny, USDA Beltsville Human Nutrition Research Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Anthocyanin Metabolism Drug: omeprazole Drug: placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Official Title: Gastric pH as a Possible Determinant of Anthocyanin Absorption
Study Start Date : May 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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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)


Outcome Measures
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Primary Outcome Measures :
  1. Gastric pH [ Time Frame: 1 hour prior to gastric emptying on Day 7 of the given intervention ]

Eligibility Criteria
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Ages Eligible for Study:   22 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01122160


Locations
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United States, Maryland
USDA's Beltsville Human Nutrition Research Center
Beltsville, Maryland, United States, 20705
Sponsors and Collaborators
USDA Beltsville Human Nutrition Research Center
Investigators
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Principal Investigator: Beverly Clevidence, Ph. D. USDA Beltsville Human Nutrition Research Center
More Information
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Responsible Party: Janet Novotny, Research Physiologist, USDA Beltsville Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT01122160    
Other Study ID Numbers: 2010-069
First Posted: May 13, 2010    Key Record Dates
Results First Posted: August 23, 2013
Last Update Posted: August 23, 2013
Last Verified: July 2013
Keywords provided by Janet Novotny, USDA Beltsville Human Nutrition Research Center:
anthocyanin
omeprazole
Prilosec
gastric pH
 proton pump inhibitor
PPI
nutrition
Additional relevant MeSH terms:
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Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
 Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action