NCT00474500

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 17, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

March 17, 2011

Status Verified

March 1, 2011

Enrollment Period

2 years

First QC Date

May 16, 2007

Last Update Submit

March 16, 2011

Conditions

Keywords

Iron absorptionCoca-Cola

Outcome Measures

Primary Outcomes (1)

  • Non-haem iron absorption

    1 year

Interventions

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women
  • Age \> 18 and \< 65

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Food Research

Norwich, Norfolk, NR4 6JF, United Kingdom

Location

Related Publications (1)

  • Collings R, Fairweather-Tait SJ, Dainty JR, Roe MA. Low-pH cola beverages do not affect women's iron absorption from a vegetarian meal. J Nutr. 2011 May;141(5):805-8. doi: 10.3945/jn.110.136507. Epub 2011 Mar 9.

MeSH Terms

Conditions

Iron Deficiencies

Interventions

Cocaine

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

TropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Study Officials

  • Susan J Fairweather-Tait

    University of East Anglia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 16, 2007

First Posted

May 17, 2007

Study Start

May 1, 2007

Primary Completion

May 1, 2009

Study Completion

May 1, 2010

Last Updated

March 17, 2011

Record last verified: 2011-03

Locations