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

Iron Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01991626
• Other study ID #: Fe-LNS
• Status: Completed
• Phase: N/A
• First received: November 18, 2013
• Last updated: September 22, 2015
• Start date: September 2013
• Est. completion date: August 2014

Study information

• Verified date: September 2015
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: August 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron Deficiency

Intervention

Dietary Supplement:
• micronutrient powder

• micronutrient powder (containing FeSO4), phytase

• Iron pyrophosphate (FePP)

• Iron sulphate

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology	DSM Nutritional Products, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No