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Trial record 8 of 729 for:    Area Under Curve AND Bioavailability

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

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ClinicalTrials.gov Identifier: NCT03030703
Recruitment Status : Completed
First Posted : January 25, 2017
Last Update Posted : January 25, 2017
Sponsor:
Collaborators:
United States Department of Agriculture Foreign Agricultural Service
American Academy of Nurse Practitioners
Information provided by (Responsible Party):
Brian Lindshield, Kansas State University

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.


Condition or disease Intervention/treatment Phase
Iron-deficiency Iron Deficiency Anemia Dietary Supplement: phytic acid Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Salivary Cystatin SN Binds to Phytic Acid and is a Predictor of Non-heme Iron Bioavailability With Phytic Acid Supplementation
Actual Study Start Date : November 11, 2016
Actual Primary Completion Date : December 10, 2016
Actual Study Completion Date : December 10, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron
Drug Information available for: Inositol

Arm Intervention/treatment
Experimental: 350 mg phytic acid
350 mg phytic acid (inositol hexaphosphate) at week 0 (before supplementation) and at week 4 (after supplementation)
Dietary Supplement: phytic acid
350 mg phytic acid (inositol hexaphosphate) three times daily for four weeks
Other Name: inositol hexaphosphate




Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03030703


Locations
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United States, Kansas
Physical Activity and Nutrition Research Consortium
Manhattan, Kansas, United States, 66502
Sponsors and Collaborators
Kansas State University
United States Department of Agriculture Foreign Agricultural Service
American Academy of Nurse Practitioners
Investigators
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Principal Investigator: Brian L Lindshield, Ph.D. Kansas State University

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Responsible Party: Brian Lindshield, Ph.D., Associate Professor, Kansas State University
ClinicalTrials.gov Identifier: NCT03030703     History of Changes
Other Study ID Numbers: SPPhyticAcidTrial
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Brian Lindshield, Kansas State University:
Phytic acid
Cystatin
Salivary proline-rich protein
antinutrient
Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Inositol
Cystatins
Salivary Cystatins
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Cysteine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action