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

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

      • Zurich, Switzerland, 8092
        • Laboratory of human nutrition - ETH

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
Experimental: Fortified savoury food product 2
Savoury food product fortified with iron
Experimental: Fortified savoury food product 3
Savoury food product fortified with iron
Experimental: Fortified savoury food product 4
Savoury food product fortified with iron

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

Keywords

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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