N/A
N=11
Gastric pH and Anthocyanin Absorption
Anthocyanin Metabolism
Bottom Line
View on ClinicalTrials.gov: NCT01122160 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Aug 2013
Primary outcome: Primary: Gastric pH — 0.96; 2.31 pH
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- omeprazole (Drug); placebo (Drug)
- Age
- Adult · 22+ yrs
- Sex
- All
- Sponsor
- USDA Beltsville Human Nutrition Research Center
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Gastric pH |
0.96; 2.31 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01122160). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.