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

September 22, 2015 updated by: Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swiss Federal Institute of Technology

Collaborators

DSM Nutritional Products, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

November 18, 2013

First Submitted That Met QC Criteria

November 21, 2013

First Posted (Estimate)

November 25, 2013

Study Record Updates

Last Update Posted (Estimate)

September 23, 2015

Last Update Submitted That Met QC Criteria

September 22, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fe-LNS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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