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Gastric pH and Anthocyanin Absorption

NCT ID: NCT01122160

Last Updated: 2013-08-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Anthocyanin Metabolism

Keywords

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anthocyanin omeprazole Prilosec gastric pH proton pump inhibitor PPI nutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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placebo

Placebo with berries (blackberries + strawberries)

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Placebo with berries (blackberries + strawberries)

omeprazole

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

Group Type EXPERIMENTAL

omeprazole

Intervention Type DRUG

omeprazole 20.6 mg tablet with berries (blackberries + strawberries)

Interventions

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omeprazole

omeprazole 20.6 mg tablet with berries (blackberries + strawberries)

Intervention Type DRUG

placebo

Placebo with berries (blackberries + strawberries)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

22 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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USDA Beltsville Human Nutrition Research Center

FED

Sponsor Role lead

Responsible Party

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Janet Novotny

Research Physiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Beverly Clevidence, Ph. D.

Role: PRINCIPAL_INVESTIGATOR

USDA Beltsville Human Nutrition Research Center

Locations

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USDA's Beltsville Human Nutrition Research Center

Beltsville, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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2010-069

Identifier Type: -

Identifier Source: org_study_id