Effect of Coca-Cola on Iron Absorption - Full Text View

Sponsor:	Institute of Food Research
Collaborators:	University of East Anglia The Coca-Cola Company
Information provided by:	Institute of Food Research
ClinicalTrials.gov Identifier:	NCT00474500

Purpose

The aim of this project is to measure the effect of Coca-Cola and Diet Coke, relative to mineral water, on non-haem iron absorption. The results from this study will quantify any enhancing effect of Coca-Cola or Diet Coke on non-haem iron absorption and will be of use to the Coca-Cola Company and the scientific and nutrition community in evaluating the nutritional value of these products.

Condition	Intervention
Iron Deficiency	Drug: Coca, Cola, Diet Coke

Study Type:	Interventional
Study Design:	Basic Science, Open Label, Active Control, Crossover Assignment, Bio-availability Study
Official Title:	Effect of Coca-Cola on Iron Absorption

Resource links provided by NLM:

MedlinePlus related topics: Diets

U.S. FDA Resources

Further study details as provided by Institute of Food Research:

Primary Outcome Measures:

Non-haem iron absorption [ Time Frame: 1 year ]

Estimated Enrollment:	16
Study Start Date:	May 2007

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00474500

Locations

United Kingdom, Norfolk
Institute of Food Research
Norwich, Norfolk, United Kingdom, NR4 6JF

Sponsors and Collaborators

Institute of Food Research

University of East Anglia

The Coca-Cola Company

Investigators

Principal Investigator:

Susan J Fairweather-Tait

University of East Anglia

More Information

No publications provided

Study ID Numbers:	IFR13/2006
Study First Received:	May 16, 2007
Last Updated:	January 29, 2009
ClinicalTrials.gov Identifier:	NCT00474500 History of Changes
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by Institute of Food Research:

Iron absorption
Coca-Cola

Additional relevant MeSH terms:

Metabolic Diseases
Hematologic Diseases
Anemia

Anemia, Hypochromic
Iron Metabolism Disorders
Anemia, Iron-Deficiency

ClinicalTrials.gov processed this record on February 08, 2010