Iron Bioavailability From Dairy Product

NCT ID: NCT02585661

Last Updated: 2016-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2015-12-31

Brief Summary

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

Detailed Description

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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

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dairy product + Salt 1

Dairy product fortified with enriched Fe-54 salt (1)

Group Type ACTIVE_COMPARATOR

Dairy product fortified with enriched Fe-54 salt (1)

Intervention Type DIETARY_SUPPLEMENT

2.5mg of Fe per 100g of product

Dairy product + Salt 2

Dairy product fortified with enriched Fe-57 salt (2)

Group Type EXPERIMENTAL

Dairy product fortified with enriched Fe-57 salt (2)

Intervention Type DIETARY_SUPPLEMENT

2.5mg of Fe per 100g of product

Interventions

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Dairy product fortified with enriched Fe-54 salt (1)

2.5mg of Fe per 100g of product

Intervention Type DIETARY_SUPPLEMENT

Dairy product fortified with enriched Fe-57 salt (2)

2.5mg of Fe per 100g of product

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maurice Beaumont

Role: PRINCIPAL_INVESTIGATOR

Metabolic Unit - Nestec

Locations

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Metabolic Unit, Clinical Development Unit, Nestec

Lausanne, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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15.06.MET

Identifier Type: -

Identifier Source: org_study_id

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