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Trial record 1 of 1 for:    NCT01991626
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Evaluation of the Effects of an Exogenous Phytase on Iron Absorption From LNS Added to Complementary Foods

This study has been completed.
Sponsor:
Collaborator:
DSM Nutritional Products, Inc.
Information provided by (Responsible Party):
Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier:
NCT01991626
First received: November 18, 2013
Last updated: September 22, 2015
Last verified: September 2015
November 18, 2013
September 22, 2015
September 2013
November 2013   (Final data collection date for primary outcome measure)
Iron bio-availability from Oral Iron Supplements [ Time Frame: 14 days ]
Iron bioavailability will be assessed with stable isotopic labels. The shift in the isotopic ratio in human whole blood 14 days after administration will be measured with mass spectrometry.
Same as current
Complete list of historical versions of study NCT01991626 on ClinicalTrials.gov Archive Site
Not Provided
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Evaluation of the Effects of an Exogenous Phytase on Iron Absorption From LNS Added to Complementary Foods
Evaluation of the Effects of an Exogenous Phytase on Iron Absorption From Lipid Nutrient Supplements Added to Complementary Foods

Previous studies on iron absorption have focused on the effects on the addition of iron absorption enhancers like ascorbic acid and EDTA to a meal and more recently the enzymatic phytic acid removal through phytase. The investigators want here to investigate the effects of fat on iron absorption with and without the addition of exogenous phytase as a potential iron absorption enhancer in lipid nutrient supplements (LNS) products compared to micronutrient powder(MNP) products.

Furthermore the investigators will evaluate the effects of Lipids- on iron absorption to induce the ileal brake by ingestion of a fat emulsion prior to a meal. Increasing the caloric density of a meal by increasing its fat content might enhance iron absorption by delaying gastric emptying, gastric acid secretion and increasing Fe stomach residence time.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Participant)
Primary Purpose: Basic Science
Iron Deficiency
  • Dietary Supplement: micronutrient powder
  • Dietary Supplement: micronutrient powder (containing FeSO4), phytase
  • Dietary Supplement: Iron pyrophosphate (FePP)
  • Dietary Supplement: Iron sulphate
  • LNS
    Maize meal mixed with Lipid Nutrient Supplement (LNS) containing micronutrient powder
    Intervention: Dietary Supplement: micronutrient powder
  • FePP-Emulsion mixed
    Fat emulsion mixed to the meal containing FePP
    Intervention: Dietary Supplement: Iron pyrophosphate (FePP)
  • FeSO4-Mixed
    meals containing FeSO4 mixed with a fat emulsion
    Intervention: Dietary Supplement: Iron sulphate
  • FePP-Emulsion before
    Fat emulsion taken before a meal containing FePP
    Intervention: Dietary Supplement: Iron pyrophosphate (FePP)
  • FeSO4- Emulsion before
    Fat emulsion taken before a maize meal containing FeSO4
    Intervention: Dietary Supplement: Iron sulphate
  • LNS-Phytase
    Maize meal mixed with LNS containing micronutrient powder and phytase
    Intervention: Dietary Supplement: micronutrient powder (containing FeSO4), phytase
  • phytase
    Maize meal containing micronutrient powder and phytase
    Intervention: Dietary Supplement: micronutrient powder (containing FeSO4), phytase
  • MNP-control
    maize meal containing micronutrient powder (MNP)
    Intervention: Dietary Supplement: micronutrient powder
  • FePP control
    Maize meal containing FePP
    Intervention: Dietary Supplement: Iron pyrophosphate (FePP)
  • FeSO4 control
    Maize meal containing FeSO4
    Intervention: Dietary Supplement: Iron sulphate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
47
August 2014
November 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Reproductive age females 18-45 years

  • Normal body mass index (17.5-25 kg/m2)
  • No intake of mineral/vitamin supplements 2 weeks before and during the study
  • No metabolic or gastrointestinal disorders
  • No food allergies or other chronic disorders or eating disorders assessed by self-report
  • Having received full oral and written information about the aims and procedures of the study
  • Willing to comply with the study procedure
  • Having provided oral and written informed consent

Exclusion Criteria:

  • Regular intake of medication (except oral contraceptives)
  • Blood donation or significant blood loss (accident, surgery) over the past 4 months
  • Currently participating in another clinical trial or having participated in another clinical trial during the last 30 days prior to the beginning of this study
  • Former participation in a study involving administration of iron stable isotopes
  • Subject who cannot be expected to comply with study protocol
  • Pregnancy or lactation
Sexes Eligible for Study: Female
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01991626
Fe-LNS
No
Not Provided
Not Provided
Not Provided
Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
Swiss Federal Institute of Technology
DSM Nutritional Products, Inc.
Principal Investigator: Michael B Zimmermann, Prof University of Zurich
Swiss Federal Institute of Technology
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP