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Completed

NCT Number: NCT02280915

Bioavailability of Iron From Savoury Food Product

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

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Key information

Conditions

Healthy Iron Deficiencies Iron Deficiency Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Laboratory of human nutrition - ETH

Zurich, 8092, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Savoury food product

Other

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Unilever R&D

Industry

Registry information

Official study title

Assessment of the Bioavailability of Iron in Iron Fortified Savoury Food Product in Healthy Women

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 3, 2014
Registry last updated
May 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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