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
Verified date | September 2015 |
Source | Swiss Federal Institute of Technology |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Ethikkommission |
Study type | Interventional |
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.
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 |
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Swiss Federal Institute of Technology | DSM Nutritional Products, Inc. |
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 |
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