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

Federal Institute of Technology (ETH) Zurich

Status: Completed

Conditions: Iron Deficiency

Treatments: Dietary Supplement: Iron sulphate; Dietary Supplement: Iron pyrophosphate (FePP); Dietary Supplement: micronutrient powder; Dietary Supplement: micronutrient powder (containing FeSO4), phytase

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01991626

Fe-LNS

Details and patient eligibility

About

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.

Enrollment: 47 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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47 participants in 10 patient groups

LNS

Other group

Description:

Maize meal mixed with Lipid Nutrient Supplement (LNS) containing micronutrient powder

Treatment:

Dietary Supplement: micronutrient powder

FePP-Emulsion mixed

Other group

Description:

Fat emulsion mixed to the meal containing FePP

Treatment:

Dietary Supplement: Iron pyrophosphate (FePP)

FeSO4-Mixed

Other group

Description:

meals containing FeSO4 mixed with a fat emulsion

Treatment:

Dietary Supplement: Iron sulphate

FePP-Emulsion before

Other group

Description:

Fat emulsion taken before a meal containing FePP

Treatment:

Dietary Supplement: Iron pyrophosphate (FePP)

FeSO4- Emulsion before

Other group

Description:

Fat emulsion taken before a maize meal containing FeSO4

Treatment:

Dietary Supplement: Iron sulphate

LNS-Phytase

Other group

Description:

Maize meal mixed with LNS containing micronutrient powder and phytase

Treatment:

Dietary Supplement: micronutrient powder (containing FeSO4), phytase

phytase

Other group

Description:

Maize meal containing micronutrient powder and phytase

Treatment:

Dietary Supplement: micronutrient powder (containing FeSO4), phytase

MNP-control

Other group

Description:

maize meal containing micronutrient powder (MNP)

Treatment:

Dietary Supplement: micronutrient powder

FePP control

Other group

Description:

Maize meal containing FePP

Treatment:

Dietary Supplement: Iron pyrophosphate (FePP)

FeSO4 control

Other group

Description:

Maize meal containing FeSO4

Treatment:

Dietary Supplement: Iron sulphate