Anthocyanin Metabolism
Conditions
Keywords
anthocyanin, omeprazole, Prilosec, gastric pH, proton pump inhibitor, PPI, nutrition
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.
Interventions
DRUGomeprazole
omeprazole 20.6 mg tablet with berries (blackberries + strawberries)
DRUGplacebo
Placebo with berries (blackberries + strawberries)
Sponsors
USDA Beltsville Human Nutrition Research Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to 59 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gastric pH | 1 hour prior to gastric emptying on Day 7 of the given intervention |
Countries
United States
Participant flow
Pre-assignment details
Discrepancy between actual enrollment and number of participants in participant flow module is due to enrolled participants no longer meeting exclusion criteria (i.e., inability to swallow capsule).
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants All participants received both interventions. | 11 |
| Total | 11 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants |
| Age Continuous | 35 years STANDARD_DEVIATION 13.8 |
| Region of Enrollment United States | 11 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 11 | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 |
Outcome results
Primary
Gastric pH
Time frame: 1 hour prior to gastric emptying on Day 7 of the given intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental | Gastric pH | 0.96 pH | Standard Deviation 0.37 |
| Placebo | Gastric pH | 2.31 pH | Standard Deviation 0.63 |