Gastric pH and Anthocyanin Absorption

This study has been completed.
Sponsor:
Information provided by:
USDA Beltsville Human Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT01122160
First received: May 10, 2010
Last updated: June 12, 2012
Last verified: June 2012

May 10, 2010
June 12, 2012
May 2010
December 2010   (final data collection date for primary outcome measure)
  • plasma anthocyanin concentration [ Time Frame: day 7: before consumption of treatment and at hours 1, 2, 3, 4, 5, and 6 after treatment ] [ Designated as safety issue: No ]
    Blood samples will be analyzed for anthocyanins. The timing of anthocyanin plasma response will be compared to gastric pH and to presence or absence of berries in the stomach as assessed by the SmartPill GI Monitoring System.
  • urine anthocyanin concentration [ Time Frame: day 7: before treatment, and for 6 hours after treatment ] [ Designated as safety issue: No ]
    Urine samples will be analyzed for anthocyanins. The timing of anthocyanin plasma response will be compared to gastric pH and to presence or absence of berries in the stomach as assessed by the SmartPill GI Monitoring System.
Same as current
Complete list of historical versions of study NCT01122160 on ClinicalTrials.gov Archive Site
  • gastric pH [ Time Frame: approximately 2-3 days after ingestion of smart pill ] [ Designated as safety issue: No ]
    The timing of anthocyanin plasma response will be compared to gastric pH and to presence or absence of berries in the stomach as assessed by the SmartPill GI Monitoring System.
  • presence/absence of berries in the stomach [ Time Frame: approximately 2-3 days after ingestion of smart pill ] [ Designated as safety issue: No ]
    The timing of anthocyanin plasma response will be compared to gastric pH and to presence or absence of berries in the stomach as assessed by the SmartPill GI Monitoring System.
Same as current
Not Provided
Not Provided
 
Gastric pH and Anthocyanin Absorption
Gastric pH as a Possible Determinant of 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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Anthocyanin Metabolism
  • Drug: omeprazole
    omeprazole 20.6 mg tablet with berries (blackberries + strawberries)
  • Drug: placebo
    Placebo with berries (blackberries + strawberries)
  • Placebo Comparator: placebo
    Placebo with berries (blackberries + strawberries)
    Intervention: Drug: placebo
  • Experimental: omeprazole
    Prilosec (omeprazol) 20.6 mg tablet with berries (blackberries + strawberries)
    Intervention: Drug: omeprazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
December 2010
December 2010   (final data collection date for primary outcome measure)

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 bezoras (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
Both
22 Years to 59 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01122160
2010-069
No
Beverly Clevidence, Ph. D., USDA
USDA Beltsville Human Nutrition Research Center
Not Provided
Principal Investigator: Beverly Clevidence, Ph. D. USDA Beltsville Human Nutrition Research Center
USDA Beltsville Human Nutrition Research Center
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP