Iron Bioavailability From Dairy Product

Iron Bioavailability From Fortified Dairy Product in Healthy Women

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Dietary supplement: Dairy product fortified with enriched Fe-54 salt (1); Dietary supplement: Dairy product fortified with enriched Fe-57 salt (2)

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Lausanne, Switzerland, 1000
    • Metabolic Unit, Clinical Development Unit, Nestec

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dairy product + Salt 1; Dairy product fortified with enriched Fe-54 salt (1)	Dietary supplement: Dairy product fortified with enriched Fe-54 salt (1); 2.5mg of Fe per 100g of product
Experimental: Dairy product + Salt 2; Dairy product fortified with enriched Fe-57 salt (2)	Dietary supplement: Dairy product fortified with enriched Fe-57 salt (2); 2.5mg of Fe per 100g of product

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)
• Investigators: Principal Investigator: Maurice Beaumont, Metabolic Unit - Nestec

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: October 16, 2015
• First Submitted That Met QC Criteria: October 22, 2015
• First Posted (Estimate): October 23, 2015

Study Record Updates

• Last Update Posted (Estimate): January 12, 2016
• Last Update Submitted That Met QC Criteria: January 11, 2016
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 15.06.MET