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Clinical Trials/NCT01991626
NCT01991626CompletedNot Applicable

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

Swiss Federal Institute of Technology0 sites47 target enrollmentStarted: September 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
47
Primary Endpoint
Iron bio-availability from Oral Iron Supplements

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Female
Accepts 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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Prof. Michael B. Zimmermann

Prof

Swiss Federal Institute of Technology

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