Regular Consumption of High Phytate Reduces Inhibitory Effect of Phytate on Iron Absorption

Iron Bioavailability Clinical Trial

Official title:

Regular Consumption of High Phytate Diet Reduces Inhibitory Effect of Phytate on Nonheme Iron Absorption in Female Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02370940
• Other study ID #: IPAAD Study
• Status: Completed
• Phase: N/A
• First received: February 11, 2015
• Last updated: February 19, 2015
• Start date: January 2013
• Est. completion date: April 2013

Study information

• Verified date: February 2015
• Source: Iowa State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Iowa State University Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate whether regular consumption of phytate dampens its negative effect on nonheme iron absorption.

Description:

Phytate is one of the main inhibitors of nonheme iron absorption. High phytate consumption is of concern in developing countries because of the high prevalence of iron and zinc deficiency in these countries. In this study, we investigated the effect of habitual consumption of a high phytate diet on the inhibitory effect of phytate on nonheme iron absorption. Thirty-two non-anemic female subjects with ferritin ≤ 30µg/L were randomized into two groups, after matching for ferritin concentration. Each group consumed either high or low phytate foods that were provided for 8 wk. Iron bioavailability from a high phytate test meal was measured using area under the curve (AUC) for serum iron at baseline and after the intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Marginal iron status (Serum ferritin <30ug/L)

• BMI in the range 18.5-24.9kg/m2

• Willing to modify diet to increase or decrease phytate intake

• Willing to give multiple blood samples at beginning and end of study

Exclusion Criteria:

• Pregnant

• Lactating

• Smoker

• Anemic (hemoglobin <120 g/L)

• Has gastro-intestinal disease/condition that can affect absorption

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Iron Bioavailability

Intervention

Other:
• High phytate intake

• Low phytate intake

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Iowa State University	HarvestPlus

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve for serum iron for assessing bioavailability		8 weeks	No