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NCT Number: NCT03030703

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

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.

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Physical Activity and Nutrition Research Consortium

Manhattan, Kansas, 66502, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

phytic acid

Dietary Supplement

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

Other names: inositol hexaphosphate

Primary outcomes

  1. Change in baseline to endline area under the curve after meal challenge at weeks 0 and 4 of intervention

    Time frame: Baseline and 4 weeks

    Change 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

  2. Change in baseline to endline hemoglobin and serum ferritin at weeks 0 and 4 of intervention

    Time frame: Baseline and 4 weeks

    Change in ferritin and hemoglobin will be measured before administration of test meals at weeks 0 and 4

  3. Change in salivary proteins at weeks 0 and 4 of intervention

    Time frame: Baseline and 4 weeks

    HPLC determination of salivary proteins will be analyzed from saliva collected before and after test meals at weeks 0 and 4 of the intervention

Sponsors and collaborators

Lead sponsor

Kansas State University

Other

Collaborators

  • American Academy of Nurse Practitioners
  • United States Department of Agriculture Foreign Agricultural Service

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 25, 2017
Registry last updated
Jan 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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