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

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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

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.


Condition or disease Intervention/treatment Phase
Iron Deficiency Dietary Supplement: micronutrient powder Dietary Supplement: micronutrient powder (containing FeSO4), phytase Dietary Supplement: Iron pyrophosphate (FePP) Dietary Supplement: Iron sulphate Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Evaluation of the Effects of an Exogenous Phytase on Iron Absorption From Lipid Nutrient Supplements Added to Complementary Foods
Study Start Date : September 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
LNS
Maize meal mixed with Lipid Nutrient Supplement (LNS) containing micronutrient powder
Dietary Supplement: micronutrient powder
FePP-Emulsion mixed
Fat emulsion mixed to the meal containing FePP
Dietary Supplement: Iron pyrophosphate (FePP)
FeSO4-Mixed
meals containing FeSO4 mixed with a fat emulsion
Dietary Supplement: Iron sulphate
FePP-Emulsion before
Fat emulsion taken before a meal containing FePP
Dietary Supplement: Iron pyrophosphate (FePP)
FeSO4- Emulsion before
Fat emulsion taken before a maize meal containing FeSO4
Dietary Supplement: Iron sulphate
LNS-Phytase
Maize meal mixed with LNS containing micronutrient powder and phytase
Dietary Supplement: micronutrient powder (containing FeSO4), phytase
phytase
Maize meal containing micronutrient powder and phytase
Dietary Supplement: micronutrient powder (containing FeSO4), phytase
MNP-control
maize meal containing micronutrient powder (MNP)
Dietary Supplement: micronutrient powder
FePP control
Maize meal containing FePP
Dietary Supplement: Iron pyrophosphate (FePP)
FeSO4 control
Maize meal containing FeSO4
Dietary Supplement: Iron sulphate



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01991626


Sponsors and Collaborators
Swiss Federal Institute of Technology
DSM Nutritional Products, Inc.
Investigators
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Principal Investigator: Michael B Zimmermann, Prof ETH Zürich
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof. Michael B. Zimmermann, Prof, Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier: NCT01991626    
Other Study ID Numbers: Fe-LNS
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: September 23, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Physiological Effects of Drugs