Gastric pH and Anthocyanin Absorption

NCT01122160 | Completed Results

• 1 other identifier: 2010-069
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Anthocyanin Metabolism

Keywords

anthocyanin; omeprazole; Prilosec; gastric pH; proton pump inhibitor; PPI; nutrition

Outcome Measures

Primary Outcomes (1)

• Gastric pH

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

Study Arms (2)

placebo

PLACEBO COMPARATOR

Placebo with berries (blackberries + strawberries)

Drug: placebo

omeprazole

EXPERIMENTAL

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

Drug: omeprazole

Interventions

omeprazole DRUG

omeprazole 20.6 mg tablet with berries (blackberries + strawberries)

omeprazole

placebo DRUG

Placebo with berries (blackberries + strawberries)

placebo

Eligibility Criteria

• Age: 22 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI 18.5 kg/m2 to 30 kg/m2
• Age 22 to 59 years

You may not qualify if:

• 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

Sponsors & Collaborators

• USDA Beltsville Human Nutrition Research Center: lead

Study Sites (1)

USDA's Beltsville Human Nutrition Research Center

Beltsville, Maryland, 20705, United States

Location

MeSH Terms

Interventions

Omeprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Beverly Clevidence
• Organization: USDA

beverly.clevidence@ars.usda.gov

301-504-8367

Study Officials

• Beverly Clevidence, Ph. D.

  USDA Beltsville Human Nutrition Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Physiologist

Study Record Dates

• First Submitted: May 10, 2010
• First Posted: May 13, 2010
• Study Start: May 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: August 23, 2013
• Results First Posted: August 23, 2013

Record last verified: 2013-07

Locations

US (1)