HealthyNCT02280915
Bioavailability of Iron From Savoury Food Product
A study testing Savoury food product in people with Healthy and Iron Deficiency, run by Unilever R&D at 1 site in Switzerland.
Trial summary
The study is designed to assess the bioavailability of iron from 4 different iron fortified savoury food products Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Healthy, Iron Deficiency
- What is being tested?
- Savoury food product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2014to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Bioavailability of Iron in Iron Fortified Savoury Food Product in Healthy Women
The study is designed to assess the bioavailability of iron from 4 different iron fortified savoury food products
- Conditions
- Healthy, Iron Deficiency
- Being tested
- Savoury food product
- Keywords
- female, subjects
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Savoury food productOther
| Study group | Role | What they receive |
|---|---|---|
| Fortified savoury food product 1 | Experimental | Savoury food product fortified with iron Receives: Other: Savoury food product |
| Fortified savoury food product 2 | Experimental | Savoury food product fortified with iron Receives: Other: Savoury food product |
| Fortified savoury food product 3 | Experimental | Savoury food product fortified with iron Receives: Other: Savoury food product |
| Fortified savoury food product 4 | Experimental | Savoury food product fortified with iron Receives: Other: Savoury food product |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 15 days
Secondary outcomes (1)
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
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unilever R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Diego Moretti, Principal investigator, ETH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02280915
- Sponsor's protocol ID
- FDS-SAV-1615
- Status last verified
- Apr 2015
- First submitted
- 21 Oct 2014
- Last updated
- 1 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Bioavailability of Iron in Iron Fortified Savoury Food Product in Healthy Women
- ClinicalTrials.gov ID
- NCT02280915
- Acronym / sponsor ID
- FDS-SAV-1615
- Conditions
- Healthy, Iron Deficiency
- Keywords
- female, subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 3 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is designed to assess the bioavailability of iron from 4 different iron fortified savoury food products
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fortified savoury food product 1 | Experimental | Other: Savoury food productSavoury food product fortified with iron |
| Fortified savoury food product 2 | Experimental | Other: Savoury food productSavoury food product fortified with iron |
| Fortified savoury food product 3 | Experimental | Other: Savoury food productSavoury food product fortified with iron |
| Fortified savoury food product 4 | Experimental | Other: Savoury food productSavoury food product fortified with iron |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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);
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Savoury food product | Other | Fortified savoury food product 1, Fortified savoury food product 2, Fortified savoury food product 3, Fortified savoury food product 4 |
Primary outcome
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
1 secondary outcome
To assess the relative bioavailability of iron from iron fortified savoury food products
Time frame: 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diego Moretti principal investigator
ETH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Savoury food product in people with Healthy and Iron Deficiency, run by Unilever R&D at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the absolute bioavailability of iron from 4 different iron fortified savoury food products (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2015.