Iron BioavailabilityNCT02370940
Regular Consumption of High Phytate Reduces Inhibitory Effect of Phytate on Iron Absorption
A study testing High phytate intake and Low phytate intake in people with Iron Bioavailability, run by Iowa State University.
Trial summary
The purpose of this study is to investigate whether regular consumption of phytate dampens its negative effect on nonheme iron absorption. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Bioavailability
- What is being tested?
- High phytate intake and Low phytate intake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Pregnant
- Lactating
- Smoker
- Anemic (hemoglobin <120 g/L)
- Has gastro-intestinal disease/condition that can affect absorption
About this study
Official title: 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.
Read the 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.
- Conditions
- Iron Bioavailability
- Being tested
- High phytate intake, Low phytate intake
- Keywords
- Iron bioavailability, phytate, serum iron curve, hepcidin, iron status
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High phytate intakeOther
Low phytate intakeOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Low phytate intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve for serum iron for assessing bioavailability
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2015 (estimated)
- Study startJan 2013
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iron BioavailabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iowa State University
- Sponsor type
- University, hospital or other
- Collaborators
- HarvestPlus
- Responsible party
- Principal investigator, Dr. Manju B. Reddy, Iowa State University
- Investigators
- Manju B Reddy, PhD, Principal investigator, Iowa State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02370940
- Sponsor's protocol ID
- IPAAD Study
- Status last verified
- Feb 2015
- First submitted
- 11 Feb 2015
- Last updated
- 25 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26041677
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regular Consumption of High Phytate Diet Reduces Inhibitory Effect of Phytate on Nonheme Iron Absorption in Female Subjects
- ClinicalTrials.gov ID
- NCT02370940
- Acronym / sponsor ID
- IPAAD Study
- Conditions
- Iron Bioavailability
- Keywords
- Iron bioavailability, phytate, serum iron curve, hepcidin, iron status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Iowa State UniversityUniversity, hospital or other
- Collaborators
- HarvestPlus
- Study start
- Jan 2013
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 25 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate whether regular consumption of phytate dampens its negative effect on nonheme iron absorption.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Phytate Diet | Experimental | Other: High phytate intakeThe 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. |
| Low Phytate Diet | Experimental | Other: Low phytate intakeThe 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Pregnant
- Lactating
- Smoker
- Anemic (hemoglobin <120 g/L)
- Has gastro-intestinal disease/condition that can affect absorption
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High phytate intake | Other | High Phytate Diet |
| Low phytate intake | Other | Low Phytate Diet |
Primary outcome
Area under the curve for serum iron for assessing bioavailability
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2015.
- Derived from this study: PubMed 26041677Armah 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.
Related trials for Iron Bioavailability
Active, not recruiting
Absorption of Iron From Stabilized Lactoferrin: A Study in Women With Iron Deficiency
Iron Deficiency (Without Anemia)
Recruiting
A Pilot Study to Evaluate the Ability of Lactoferrin to Modulate Iron Homeostasis and Exercise Performance in Exercising Females
Iron Deficiencies, Low Ferritin
Recruiting
Maximizing the Benefits of Iron in Ready-to-Use Therapeutic Foods for Malnourished Children in Kenya
Iron Absorption, Iron Deficiencies
Recruiting
Effect of Chitin and Ascorbic Acid on Dietary Insect Iron Absorption
Iron Deficiency (Without Anemia)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manju B Reddy, PhD principal investigator
Iowa State University
Questions about this trial
What is this clinical trial studying?
A study testing High phytate intake and Low phytate intake in people with Iron Bioavailability, run by Iowa State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve for serum iron for assessing bioavailability (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02370940, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2015.