Iron Bioavailability From Dairy Product

Healthy Volunteers Clinical Trial

Official title:

Iron Bioavailability From Fortified Dairy Product in Healthy Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02585661
• Other study ID #: 15.06.MET
• Status: Completed
• Phase: N/A
• First received: October 16, 2015
• Last updated: January 11, 2016
• Start date: October 2015
• Est. completion date: December 2015

Study information

• Verified date: October 2015
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

Determination of fractional iron absorption from dairy product fortified with 2 labelled iron compounds

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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,

• 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.

Study Design

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Dietary Supplement:
• Dairy product fortified with enriched Fe-54 salt (1)
2.5mg of Fe per 100g of product
• Dairy product fortified with enriched Fe-57 salt (2)
2.5mg of Fe per 100g of product

Locations

Country	Name	City	State
Switzerland	Metabolic Unit, Clinical Development Unit, Nestec	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	14 days after the last stable isotope administration	No
Secondary	Measurement of plasma ferritin as biomarker of Fe status	The plasma ferritin will be measured before the administration of test meal including iron isotopes	On the 1st day of the stable isotope administration	No