NCT02370940

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2013

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 25, 2015

Completed
Last Updated

February 25, 2015

Status Verified

February 1, 2015

Enrollment Period

3 months

First QC Date

February 11, 2015

Last Update Submit

February 19, 2015

Conditions

Keywords

Iron bioavailabilityphytateserum iron curvehepcidiniron status

Outcome Measures

Primary Outcomes (1)

  • Area under the curve for serum iron for assessing bioavailability

    8 weeks

Study Arms (2)

High Phytate Diet

EXPERIMENTAL

The high phytate diet group was required to consume a high phytate diet for 8 weeks. The high phytate foods were provided for subjects. They received whole grain ready-to-eat cereals, whole wheat pasta/spaghetti, tortillas, bagels, bread and dinner rolls, corn tortillas, brown rice, canned black beans, edamame and tofu, and were encouraged to consume generous amounts of nuts and other legume products high in phytate.

Other: High phytate intake

Low Phytate Diet

EXPERIMENTAL

The low phytate diet group was required to consume a low phytate diet for 8 weeks. They received foods similar to those for the high phytate diet group but which were made from refined wheat and white rice, eggs and cheese, and were instructed to avoid high phytate foods.

Other: Low phytate intake

Interventions

High Phytate Diet
Low Phytate Diet

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant
  • Lactating
  • Smoker
  • Anemic (hemoglobin \<120 g/L)
  • Has gastro-intestinal disease/condition that can affect absorption

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Armah SM, Boy E, Chen D, Candal P, Reddy MB. Regular Consumption of a High-Phytate Diet Reduces the Inhibitory Effect of Phytate on Nonheme-Iron Absorption in Women with Suboptimal Iron Stores. J Nutr. 2015 Aug;145(8):1735-9. doi: 10.3945/jn.114.209957. Epub 2015 Jun 3.

Study Officials

  • Manju B Reddy, PhD

    Iowa State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 11, 2015

First Posted

February 25, 2015

Study Start

January 1, 2013

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

February 25, 2015

Record last verified: 2015-02