- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00474500
Effect of Coca-Cola on Iron Absorption
Study Overview
Detailed Description
Previous studies have suggested that Coca-Cola may enhance absorption of non-haem iron. A randomized cross-over trial will be undertaken to compare the absorption of iron added to a pizza meal consumed with either Coca-Cola, Diet Coke or mineral water. Pizza containing added iron, labelled with an iron stable isotope (Fe-58), will be consumed for lunch on two consecutive days with either a Coca-Cola, Diet Coke or mineral water drink. Iron absorption from the pizza will be determined using the erythrocyte incorporation technique.
A baseline blood sample will be taken prior to consuming the first test meal (pizza + drink 1) and after approximately 15 days, a second fasting blood sample will be taken prior to consumption of a second set of test meals (pizza + drink 2). Iron isotope enrichment of the blood sample will be used as a baseline for the second set of test meals and to calculate absorption from the first set of test meals. A third blood sample will be taken after approximately 30 days and the iron isotope enrichment will be used as a baseline for the third set of test meals (pizza + drink 3) and to determine absorption from the second set of test meals. At about 45 days a final blood sample will be taken to determine absorption from the third set of test meals. Iron absorption will be calculated from the isotopic enrichment in blood, assuming that 80% of absorbed iron is incorporated into red blood cells. Absorption of iron consumed with Coca-Cola and Diet Coke will be compared with iron absorption when consumed with mineral water. The order in which the volunteers will be given the drinks will be randomised.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Norfolk
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Norwich, Norfolk, United Kingdom, NR4 6JF
- Institute of Food Research
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women
- Age > 18 and < 65
Exclusion Criteria:
- Men
- Age < 18 or > 65
- BMI <18.5 or > 35
- Serum ferritin value of <12 or >50µg/L (±10% to allow for day to day and analytical variation)
- Volunteers will be excluded if they are found to have depressed or elevated blood pressure measurements (<90/50 or <95/55 if symptomatic or >160/100)
- Diagnosed with a long-term illness requiring active treatment, e.g. diabetes, cancer, cardiovascular disease.
- Gastrointestinal disease (excluding hiatus hernia unless symptomatic or study intervention/procedure is contraindicated)
- Regular prescribed medication that may interfere with iron metabolism
- Regular use of antacids and laxatives (at least once a week)
- Women who are pregnant or less than 12 months since giving birth
- Women breast feeding
- Vitamin supplements with or without minerals if taken more than once a week, and unwillingness to discontinue occasional use for the duration of study
- Unwillingness to discontinue use of herbal supplements for the duration of study
- Use of antibiotics within four weeks prior to study start
- Parallel participation in another study which involves dietary interventions or sampling of blood that may increase the volume taken above 500ml in a 4-month period
- Asthma requiring treatment within the last two years
- Results of clinical screening which indicate, or are judged by the HNU Medical Advisor to be indicative of a health problem which could compromise the well-being of the volunteer if they participated or which would affect the study data.
- Allergy to any of the ingredients in the test meals
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Non-haem iron absorption
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Susan J Fairweather-Tait, University of East Anglia
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IFR13/2006
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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