Anthocyanin MetabolismNCT01122160
Gastric pH and Anthocyanin Absorption
A study testing omeprazole in people with Anthocyanin Metabolism, run by USDA Beltsville Human Nutrition Research Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Anthocyanin Metabolism
- What is being tested?
- omeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Dec 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 18.5 kg/m2 to 30 kg/m2
- Age 22 to 59 years
Who cannot join
- 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
Show all 27Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA's Beltsville Human Nutrition Research Center
Beltsville, Maryland, 20705
About this study
Official title: 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.
- Conditions
- Anthocyanin Metabolism
- Being tested
- omeprazole, placebo
- Keywords
- anthocyanin, omeprazole, Prilosec, gastric pH, proton pump inhibitor, PPI, nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omeprazoleDrug
omeprazole 20.6 mg tablet with berries (blackberries + strawberries)
placeboDrug
Placebo with berries (blackberries + strawberries)
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Placebo with berries (blackberries + strawberries) Receives: Drug: placebo |
| omeprazole | Experimental | Prilosec (omeprazole) 20.6 mg tablet with berries (blackberries + strawberries) Receives: Drug: omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric pH
Measured: 1 hour prior to gastric emptying on Day 7 of the given intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2010 (estimated)
- Study startMay 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anthocyanin MetabolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA Beltsville Human Nutrition Research Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Janet Novotny, USDA Beltsville Human Nutrition Research Center
- Investigators
- Beverly Clevidence, Ph. D., Principal investigator, USDA Beltsville Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01122160
- Sponsor's protocol ID
- 2010-069
- Status last verified
- Jul 2013
- First submitted
- 10 May 2010
- Last updated
- 23 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric pH as a Possible Determinant of Anthocyanin Absorption
- ClinicalTrials.gov ID
- NCT01122160
- Acronym / sponsor ID
- 2010-069
- Conditions
- Anthocyanin Metabolism
- Keywords
- anthocyanin, omeprazole, Prilosec, gastric pH, proton pump inhibitor, PPI, nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- USDA Beltsville Human Nutrition Research CenterUS federal agency
- Study start
- May 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 13 May 2010 (estimated)
- Results
- Posted 23 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: placeboPlacebo with berries (blackberries + strawberries) |
| omeprazole | Experimental | Drug: omeprazolePrilosec (omeprazole) 20.6 mg tablet with berries (blackberries + strawberries) |
Who may qualify
- Ages
- 22 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI 18.5 kg/m2 to 30 kg/m2
- Age 22 to 59 years
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| omeprazoleomeprazole 20.6 mg tablet with berries (blackberries + strawberries) | Drug | omeprazole |
| placeboPlacebo with berries (blackberries + strawberries) | Drug | placebo |
Primary outcome
Gastric pH
Time frame: 1 hour prior to gastric emptying on Day 7 of the given intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beverly Clevidence, Ph. D. principal investigator
USDA Beltsville Human Nutrition Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing omeprazole in people with Anthocyanin Metabolism, run by USDA Beltsville Human Nutrition Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric pH (time frame: 1 hour prior to gastric emptying on Day 7 of the given intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2013.