- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02370940
Regular Consumption of High Phytate Reduces Inhibitory Effect of Phytate on Iron Absorption
February 19, 2015 updated by: Dr. Manju B. Reddy, Iowa State University
Regular Consumption of High Phytate Diet Reduces Inhibitory Effect of Phytate on Nonheme Iron Absorption in Female Subjects
The purpose of this study is to investigate whether regular consumption of phytate dampens its negative effect on nonheme iron absorption.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 33 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: High Phytate Diet
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.
|
|
Experimental: Low Phytate Diet
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the curve for serum iron for assessing bioavailability
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
April 1, 2013
Study Completion (Actual)
April 1, 2013
Study Registration Dates
First Submitted
February 11, 2015
First Submitted That Met QC Criteria
February 19, 2015
First Posted (Estimate)
February 25, 2015
Study Record Updates
Last Update Posted (Estimate)
February 25, 2015
Last Update Submitted That Met QC Criteria
February 19, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- IPAAD Study
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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