Bioavailability of Iron From Savoury Food Product

NCT ID: NCT02280915

Last Updated: 2015-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-03-31

Brief Summary

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

Conditions

Healthy; Iron Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Fortified savoury food product 1

Savoury food product fortified with iron

Group Type: EXPERIMENTAL

Savoury food product

Intervention Type: OTHER

Fortified savoury food product 2

Savoury food product fortified with iron

Group Type: EXPERIMENTAL

Savoury food product

Intervention Type: OTHER

Fortified savoury food product 3

Savoury food product fortified with iron

Group Type: EXPERIMENTAL

Savoury food product

Intervention Type: OTHER

Fortified savoury food product 4

Savoury food product fortified with iron

Group Type: EXPERIMENTAL

Savoury food product

Intervention Type: OTHER

Interventions

Savoury food product

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Unilever R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Diego Moretti

Role: PRINCIPAL_INVESTIGATOR

ETH

Locations

Laboratory of human nutrition - ETH

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

FDS-SAV-1615

Identifier Type: -

Identifier Source: org_study_id