Bioavailability of Iron From Savoury Food Product

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02280915
• Other study ID #: FDS-SAV-1615
• Status: Completed
• Phase: N/A
• First received: October 21, 2014
• Last updated: April 30, 2015
• Start date: October 2014
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: Unilever R&D
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Healthy
• Iron Deficiency

Intervention

Other:
• Savoury food product

Locations

Country	Name	City	State
Switzerland	Laboratory of human nutrition - ETH	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Unilever R&D

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the absolute bioavailability of iron from 4 different iron fortified savoury food products	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	15 days	No
Secondary	To assess the relative bioavailability of iron from iron fortified savoury food products	The absolute bioavailability results of each of the iron fortified savoury products as obtained under the primary objective will be compared with each other	15 days	No