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Trial record 64 of 779 for:    Area Under Curve AND meal

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

Tracking Information
First Submitted Date  ICMJE January 23, 2017
First Posted Date  ICMJE January 25, 2017
Last Update Posted Date January 25, 2017
Actual Study Start Date  ICMJE November 11, 2016
Actual Primary Completion Date December 10, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2017)
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cystatin SN Binds to Phytic Acid and Predicts Non-heme Iron Bioavailability
Official Title  ICMJE Salivary Cystatin SN Binds to Phytic Acid and is a Predictor of Non-heme Iron Bioavailability With Phytic Acid Supplementation
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Iron-deficiency
  • Iron Deficiency Anemia
Intervention  ICMJE Dietary Supplement: phytic acid
350 mg phytic acid (inositol hexaphosphate) three times daily for four weeks
Other Name: inositol hexaphosphate
Study Arms  ICMJE Experimental: 350 mg phytic acid
350 mg phytic acid (inositol hexaphosphate) at week 0 (before supplementation) and at week 4 (after supplementation)
Intervention: Dietary Supplement: phytic acid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 24, 2017)
7
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 10, 2016
Actual Primary Completion Date December 10, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03030703
Other Study ID Numbers  ICMJE SPPhyticAcidTrial
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Brian Lindshield, Kansas State University
Study Sponsor  ICMJE Kansas State University
Collaborators  ICMJE
  • United States Department of Agriculture Foreign Agricultural Service
  • American Academy of Nurse Practitioners
Investigators  ICMJE
Principal Investigator: Brian L Lindshield, Ph.D. Kansas State University
PRS Account Kansas State University
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP