Bioavailability of Iron From Savoury Food Product

Unilever

Status: Completed

Conditions: Iron Deficiency; Healthy

Treatments: Other: Savoury food product

Study type: Interventional

Funder types: Industry

Identifiers

NCT02280915

FDS-SAV-1615

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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24 participants in 4 patient groups

Fortified savoury food product 1

Experimental group

Description:

Savoury food product fortified with iron

Treatment:

Other: Savoury food product

Fortified savoury food product 2

Experimental group

Description:

Savoury food product fortified with iron

Treatment:

Other: Savoury food product

Fortified savoury food product 3

Experimental group

Description:

Savoury food product fortified with iron

Treatment:

Other: Savoury food product

Fortified savoury food product 4

Experimental group

Description:

Savoury food product fortified with iron

Treatment:

Other: Savoury food product