- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02280915
Bioavailability of Iron From Savoury Food Product
April 30, 2015 updated by: Unilever R&D
Assessment of the Bioavailability of Iron in Iron Fortified Savoury Food Product in Healthy Women
The study is designed to assess the bioavailability of iron from 4 different iron fortified savoury food products
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Zurich, Switzerland, 8092
- Laboratory of human nutrition - ETH
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 38 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Healthy female subjects;
- Age > 18 and < 40 years at screening;
- Body weight <65 kg;
- Apparently healthy: no medical conditions which might affect study measurements (judged by study physician);
- With iron deficiency (Serum ferritin <15µg/L);
- Currently not smoking and being a non-smoker for at least six months and no reported use of any nicotine containing products in the six months preceding the study and during the study itself;
- Willing and able to participate in the study; Having given a written informed consent.
Exclusion Criteria:
- Blood donation or significant blood loss over the past 6 months;
- Reported use of any medically- or self-prescribed diet;
- Use of medication (except oral contraceptives)
- Use of vitamin or mineral supplements and unwillingness to discontinue their use two weeks prior the study and during the study;
- Is pregnant or will be planning pregnancy during the study period;
- Is lactating or has been lactating in the 6 weeks before pre-study investigation and/or during the study period;
- Known gastrointestinal or metabolic disorders;
- Participation in another clinical trial during the last 30 days prior to the beginning of the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fortified savoury food product 1
Savoury food product fortified with iron
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|
Experimental: Fortified savoury food product 2
Savoury food product fortified with iron
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|
Experimental: Fortified savoury food product 3
Savoury food product fortified with iron
|
|
Experimental: Fortified savoury food product 4
Savoury food product fortified with iron
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To assess the absolute bioavailability of iron from 4 different iron fortified savoury food products
Time Frame: 15 days
|
Amounts of Fe isotopic label present in the blood 14 days after administration of the fortified savoury food product will be calculated based on measured shifts in the iron isotope ratios in the blood samples (Day 15) compared to baseline and the amount of iron circulating in the body
|
15 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To assess the relative bioavailability of iron from iron fortified savoury food products
Time Frame: 15 days
|
The absolute bioavailability results of each of the iron fortified savoury products as obtained under the primary objective will be compared with each other
|
15 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Diego Moretti, ETH
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (Actual)
March 1, 2015
Study Completion (Actual)
March 1, 2015
Study Registration Dates
First Submitted
October 21, 2014
First Submitted That Met QC Criteria
October 29, 2014
First Posted (Estimate)
November 2, 2014
Study Record Updates
Last Update Posted (Estimate)
May 1, 2015
Last Update Submitted That Met QC Criteria
April 30, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FDS-SAV-1615
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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