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OpenTrials
Completed

NCT Number: NCT01122160

Gastric pH and 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.

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Key information

Conditions

Anthocyanin Metabolism

Age range

22 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

USDA's Beltsville Human Nutrition Research Center

Beltsville, Maryland, 20705, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omeprazole

Drug

omeprazole 20.6 mg tablet with berries (blackberries + strawberries)

Placebo

Drug

Placebo with berries (blackberries + strawberries)

Primary outcomes

  1. Gastric pH

    Time frame: 1 hour prior to gastric emptying on Day 7 of the given intervention

Sponsors and collaborators

Lead sponsor

USDA Beltsville Human Nutrition Research Center

Fed

Registry information

Official study title

Gastric pH as a Possible Determinant of Anthocyanin Absorption

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 13, 2010
Registry last updated
Aug 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.