Bioavailability of Iron From Savoury Food Product

Not Applicable

Completed

• Conditions: Iron Deficiency; Healthy
• Interventions: Other: Savoury food product

• Registration Number: NCT02280915
• Lead Sponsor: Unilever R&D

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-21
• Study First Submitted QC: 2014-10-29
• Study First Posted: 2014-11-02
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-30
• Last Update Posted: 2015-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Fortified savoury food product 2	Savoury food product	Savoury food product fortified with iron
Fortified savoury food product 3	Savoury food product	Savoury food product fortified with iron
Fortified savoury food product 4	Savoury food product	Savoury food product fortified with iron
Fortified savoury food product 1	Savoury food product	Savoury food product fortified with iron

Primary Outcome Measures

Name	Time	Method
To assess the absolute bioavailability of iron from 4 different iron fortified savoury food products	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

Name	Time	Method
To assess the relative bioavailability of iron from iron fortified savoury food products	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

Trial Locations

Locations (1)

Laboratory of human nutrition - ETH; 🇨🇭 Zurich, Switzerland