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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01991626

Enrollment

Registered

2013-11-25

Start date

2013-09-30

Completion date

2014-08-31

Last updated

2015-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron Deficiency

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.

Interventions

DIETARY_SUPPLEMENTmicronutrient powder

DIETARY_SUPPLEMENTmicronutrient powder (containing FeSO4), phytase

DIETARY_SUPPLEMENTIron pyrophosphate (FePP)

DIETARY_SUPPLEMENTIron sulphate

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Iron bio-availability from Oral Iron Supplements	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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026