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Bioavailability of Iron From Savoury Food Product

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02280915
Recruitment Status : Completed
First Posted : November 2, 2014
Last Update Posted : May 1, 2015
Sponsor:
Information provided by (Responsible Party):
Unilever R&D

Brief Summary:
The study is designed to assess the bioavailability of iron from 4 different iron fortified savoury food products

Condition or disease Intervention/treatment Phase
Healthy Iron Deficiency Other: Savoury food product Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Assessment of the Bioavailability of Iron in Iron Fortified Savoury Food Product in Healthy Women
Study Start Date : October 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arm Intervention/treatment
Experimental: Fortified savoury food product 1
Savoury food product fortified with iron
Other: Savoury food product
Experimental: Fortified savoury food product 2
Savoury food product fortified with iron
Other: Savoury food product
Experimental: Fortified savoury food product 3
Savoury food product fortified with iron
Other: Savoury food product
Experimental: Fortified savoury food product 4
Savoury food product fortified with iron
Other: Savoury food product



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02280915


Locations
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Switzerland
Laboratory of human nutrition - ETH
Zurich, Switzerland, 8092
Sponsors and Collaborators
Unilever R&D
Investigators
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Principal Investigator: Diego Moretti ETH
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Responsible Party: Unilever R&D
ClinicalTrials.gov Identifier: NCT02280915    
Other Study ID Numbers: FDS-SAV-1615
First Posted: November 2, 2014    Key Record Dates
Last Update Posted: May 1, 2015
Last Verified: April 2015
Keywords provided by Unilever R&D:
female
subjects
Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases