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Evaluation of the Effects of an Exogenous Phytase on Iron Absorption From LNS Added to Complementary Foods

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01991626
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : September 23, 2015
Sponsor:
Collaborator:
DSM Nutritional Products, Inc.
Information provided by (Responsible Party):
Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology

Tracking Information
First Submitted Date  ICMJE November 18, 2013
First Posted Date  ICMJE November 25, 2013
Last Update Posted Date September 23, 2015
Study Start Date  ICMJE September 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 21, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Effects of an Exogenous Phytase on Iron Absorption From LNS Added to Complementary Foods
Official Title  ICMJE Evaluation of the Effects of an Exogenous Phytase on Iron Absorption From Lipid Nutrient Supplements Added to Complementary Foods
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE Iron Deficiency
Intervention  ICMJE
  • Dietary Supplement: micronutrient powder
  • Dietary Supplement: micronutrient powder (containing FeSO4), phytase
  • Dietary Supplement: Iron pyrophosphate (FePP)
  • Dietary Supplement: Iron sulphate
Study Arms  ICMJE
  • 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
Publications * Monnard A, Moretti D, Zeder C, Steingötter A, Zimmermann MB. The effect of lipids, a lipid-rich ready-to-use therapeutic food, or a phytase on iron absorption from maize-based meals fortified with micronutrient powders. Am J Clin Nutr. 2017 Jun;105(6):1521-1527. doi: 10.3945/ajcn.116.142976. Epub 2017 May 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 21, 2013)
47
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01991626
Other Study ID Numbers  ICMJE Fe-LNS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
Study Sponsor  ICMJE Swiss Federal Institute of Technology
Collaborators  ICMJE DSM Nutritional Products, Inc.
Investigators  ICMJE
Principal Investigator: Michael B Zimmermann, Prof ETH Zürich
PRS Account Swiss Federal Institute of Technology
Verification Date September 2015

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