Healthy VolunteersNCT02585661
Iron Bioavailability From Dairy Product
A study testing Dairy product fortified with enriched Fe-54 salt (1) and Dairy product fortified with enriched Fe-57 salt (2) in people with Healthy Volunteers, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
Trial summary
Determination of fractional iron absorption from dairy product fortified with 2 labelled iron compounds Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Dairy product fortified with enriched Fe-54 salt (1) and Dairy product fortified with enriched Fe-57 salt (2)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2015to Dec 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 18-40 years old,
- Healthy, based on the medical screening visit including a blood formula and biochemistry,
- Normal BMI for age (18.5-25.0),
- Weight less than 65 kg,
- Having obtained informed consent prior trial entry.
Who cannot join
- Anemia or polycythemia respectively evidenced,
- Significant blood losses over the past 6 months,
- Plasma ferritin out of 8-50 ug/L range.
- Any infectious and inflammatory disease in the past four weeks,
- Relevant digestive (intestinal, gastric, hepatic or pancreatic), renal, metabolic disease,
- Known food allergy,
Show all 17Show fewer
- Pregnancy (anamnesis) and/or lactation,
- History of cancer within the past year,
- Significant weight loss during the last 3 months (5% and more),
- medication or supplement which may impact red cells count, Hb or Ht
- Fe supplementation or perfusion in the last three months,
- Smokers (>5 cigarettes),
- Have a high alcohol consumption (more than 2 drinks/day),
- Consumption of illicit drugs anamnesis only,
- Subject having a hierarchical link with the Investigator or co-investigators,
- Subject who cannot be expected to comply with treatment or study procedure,
- participating or having participated in another clinical trial during the past month prior to the beginning of this study.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Metabolic Unit, Clinical Development Unit, Nestec
Lausanne, 1000
About this study
Official title: Iron Bioavailability From Fortified Dairy Product in Healthy Women
Determination of fractional iron absorption from dairy product fortified with 2 labelled iron compounds
Read the detailed description
This single center trial will be double-blind, controlled randomized with a crossover trial. One group (n=10) will start the study with the consumption of a Fe-54 salt fortified dairy product, while the other group will start the study with the consumption of Fe-57 salt fortified dairy product. The day after, in a cross over design, subjects will be administered the alternative test product. A blood sampling will be performed 14 days after the last stable isotope administration to allow the measurement of Fe stable isotope ratios and the calculation of Fe absorption. The duration of the trial will be 16 days in total.
The total sample size is 20 enrolled subjects. Patients will be healthy females aged 18-40 years old
- Conditions
- Healthy Volunteers
- Being tested
- Dairy product fortified with enriched Fe-54 salt (1), Dairy product fortified with enriched Fe-57 salt (2)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dairy product fortified with enriched Fe-54 salt (1)Dietary supplement
2.5mg of Fe per 100g of product
Dairy product fortified with enriched Fe-57 salt (2)Dietary supplement
2.5mg of Fe per 100g of product
| Study group | Role | What they receive |
|---|---|---|
| Dairy product + Salt 1 | Active comparator | Dairy product fortified with enriched Fe-54 salt (1) Receives: Dietary Supplement: Dairy product fortified with enriched Fe-54 salt (1) |
| Dairy product + Salt 2 | Experimental | Dairy product fortified with enriched Fe-57 salt (2) Receives: Dietary Supplement: Dairy product fortified with enriched Fe-57 salt (2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the isotopic ratio of iron in blood at week 2
The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes
Measured: 14 days after the last stable isotope administration
Secondary outcomes (1)
Measurement of plasma ferritin as biomarker of Fe status
The plasma ferritin will be measured before the administration of test meal including iron isotopes
Measured: On the 1st day of the stable isotope administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maurice Beaumont, Principal investigator, Metabolic Unit - Nestec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02585661
- Sponsor's protocol ID
- 15.06.MET
- Status last verified
- Oct 2015
- First submitted
- 16 Oct 2015
- Last updated
- 12 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Bioavailability From Fortified Dairy Product in Healthy Women
- ClinicalTrials.gov ID
- NCT02585661
- Acronym / sponsor ID
- 15.06.MET
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 23 Oct 2015 (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.
Determination of fractional iron absorption from dairy product fortified with 2 labelled iron compounds
Detailed description
This single center trial will be double-blind, controlled randomized with a crossover trial. One group (n=10) will start the study with the consumption of a Fe-54 salt fortified dairy product, while the other group will start the study with the consumption of Fe-57 salt fortified dairy product. The day after, in a cross over design, subjects will be administered the alternative test product. A blood sampling will be performed 14 days after the last stable isotope administration to allow the measurement of Fe stable isotope ratios and the calculation of Fe absorption. The duration of the trial will be 16 days in total.
The total sample size is 20 enrolled subjects. Patients will be healthy females aged 18-40 years old
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dairy product + Salt 1 | Active comparator | Dietary Supplement: Dairy product fortified with enriched Fe-54 salt (1)Dairy product fortified with enriched Fe-54 salt (1) |
| Dairy product + Salt 2 | Experimental | Dietary Supplement: Dairy product fortified with enriched Fe-57 salt (2)Dairy product fortified with enriched Fe-57 salt (2) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women aged 18-40 years old,
- Healthy, based on the medical screening visit including a blood formula and biochemistry,
- Normal BMI for age (18.5-25.0),
- Weight less than 65 kg,
- Having obtained informed consent prior trial entry.
Key exclusion criteria (17 listed)
- Anemia or polycythemia respectively evidenced,
- Significant blood losses over the past 6 months,
- Plasma ferritin out of 8-50 ug/L range.
- Any infectious and inflammatory disease in the past four weeks,
- Relevant digestive (intestinal, gastric, hepatic or pancreatic), renal, metabolic disease,
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 |
|---|---|---|
| Dairy product fortified with enriched Fe-54 salt (1)2.5mg of Fe per 100g of product | Dietary supplement | Dairy product + Salt 1 |
| Dairy product fortified with enriched Fe-57 salt (2)2.5mg of Fe per 100g of product | Dietary supplement | Dairy product + Salt 2 |
Primary outcome
Change from baseline in the isotopic ratio of iron in blood at week 2
Time frame: 14 days after the last stable isotope administration
The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes
1 secondary outcome
Measurement of plasma ferritin as biomarker of Fe status
Time frame: On the 1st day of the stable isotope administration
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 12 Jan 2016.
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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.
Maurice Beaumont principal investigator
Metabolic Unit - Nestec
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dairy product fortified with enriched Fe-54 salt (1) and Dairy product fortified with enriched Fe-57 salt (2) in people with Healthy Volunteers, run by Société des Produits Nestlé (SPN) 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 5 inclusion and 17 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 12 Jan 2016. 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?
Change from baseline in the isotopic ratio of iron in blood at week 2 (time frame: 14 days after the last stable isotope administration). 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 12 Jan 2016.