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

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the Effects of an Exogenous Phytase on Iron Absorption From Lipid Nutrient Supplements Added to Complementary Foods

Conditions
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Iron Deficiency

Intervention / Treatment
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* Dietary Supplement: micronutrient powder
* Dietary Supplement: micronutrient powder (containing FeSO4), phytase
* Dietary Supplement: Iron pyrophosphate (FePP)
* Dietary Supplement: Iron sulphate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Iron bio-availability from Oral Iron Supplements | 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 |