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Cystatin SN Binds to Phytic Acid and Predicts Non-heme Iron Bioavailability

Salivary Cystatin SN Binds to Phytic Acid and is a Predictor of Non-heme Iron Bioavailability With Phytic Acid Supplementation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03030703
Enrollment
7
Registered
2017-01-25
Start date
2016-11-11
Completion date
2016-12-10
Last updated
2017-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron-deficiency, Iron Deficiency Anemia

Keywords

Phytic acid, Cystatin, Salivary proline-rich protein, antinutrient

Brief summary

Phytic acid is a known inhibitor of iron bioavailability, although long term studies have suggested possibly exaggerated findings compared to single meal studies, pointing to phytic acid adaptation over time. Salivary proline-rich proteins have been found to reduce tannin-iron chelation, but studies have not explored changes in salivary proteins that may result in phytic acid adaptation. The primary objectives of this study are: 1) To determine whether phytic acid impacts iron bioavailability or status when consumed over time 2) to test whether salivary protein production may impact iron bioavailability with phytic acid supplementation, and 3) to explore in vitro phytic acid salivary binding. Secondary objectives included assessment of the reliability of astringency as a measure of salivary protein production and iron absorption. The study was conducted in an iron absorption study of 7 women, aged 18-35 years old, to determine iron bioavailability with supplementation of 350 mg phytic acid before and after regular, three times daily supplementation for four weeks. Direct iron absorption was measured using area under the curve. Iron status was measured by changes in hemoglobin and ferritin, and was adjusted by participant c-reactive protein levels. Salivary samples were collected before and after supplement consumption during meal challenges, and analyzed on HPLC and by ELISA. Astringency testing was conducted at the end of each meal challenge. In vitro saliva-phytic acid modeling was explored on HPLC, MALDI-TOF, and ELISA. Iron absorption and status markers were analyzed by ANOVA, and mixed-modeling followed by pairwise comparison by least significant differences. Pearson's correlations were used to correlated salivary proteins and astringency with iron bioavailability. The present study will provide important information regarding the approximate influence of phytic acid consumption on iron bioavailability and storage over time in regards to salivary proteins. It will also give context to the role of salivary proteins with phytic acid consumption over time. Data will also help to delineate possible physiological mechanisms underlying phytic acid adaptation and possible ways to detect individuals who better adapt than others.

Interventions

DIETARY_SUPPLEMENTphytic acid

350 mg phytic acid (inositol hexaphosphate) three times daily for four weeks

Sponsors

United States Department of Agriculture Foreign Agricultural Service
CollaboratorOTHER
American Academy of Nurse Practitioners
CollaboratorUNKNOWN
Kansas State University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

* Female, 18-35 years' old * Non-obese BMI (18-29.9) * Signed informed consent

Exclusion criteria

* Oral disease * Gastrointestinal disease * Tobacco user * Heavy alcohol user * Pregnancy (assessed by pregnancy test) * Lactation * Medications affecting iron bioavailability * Vitamin or mineral supplementation (other than vitamin B12)

Design outcomes

Primary

MeasureTime frameDescription
Change in baseline to endline area under the curve after meal challenge at weeks 0 and 4 of interventionBaseline and 4 weeksChange in area under the curve will be measured after administration of test meal including ferrous sulfate and condensed tannin supplementation at weeks 0 and 4
Change in baseline to endline hemoglobin and serum ferritin at weeks 0 and 4 of interventionBaseline and 4 weeksChange in ferritin and hemoglobin will be measured before administration of test meals at weeks 0 and 4
Change in salivary proteins at weeks 0 and 4 of interventionBaseline and 4 weeksHPLC determination of salivary proteins will be analyzed from saliva collected before and after test meals at weeks 0 and 4 of the intervention

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026