Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
Trial record 11 of 732 for:    Area Under Curve AND Bioavailability

Multiple Daily Condensed Tannin Supplementation and Iron Bioavailability: The Tannin Dose Response Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03030716
Recruitment Status : Completed
First Posted : January 25, 2017
Last Update Posted : January 25, 2017
Sponsor:
Collaborator:
United States Department of Agriculture Foreign Agricultural Service
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 June 25, 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 each 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 each 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 each 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 each 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 Multiple Daily Condensed Tannin Supplementation and Iron Bioavailability: The Tannin Dose Response Trial
Official Title  ICMJE Long-term, Multiple Daily Condensed Tannin Supplementation in Increasing Concentrations Does Not Affect Iron Status or Bioavailability: Results From the Tannin-dose Response Trial.
Brief Summary

Tannins are known to inhibit iron absorption through formation of insoluble tannin-mineral complexes, and have thus been termed 'antinutritional.' Despite this, there is evidence that adaptation to similar antinutritional factors is possible when consumed over time. Limitations in current studies include short (single meal) duration, and use of incongruent tannin types from the condensed tannins that are commonly consumed. If adaptation to tannins does happen, it may be due to salivary proline-rich proteins, which have been found to be protective of iron status in animal models. The primary objectives of this study are: 1) To determine whether condensed tannins impact iron bioavailability or status when consumed in multi-dose, multiple daily supplements and 2) to test whether salivary protein production may impact iron bioavailability with tannin supplementation. Secondary objectives included assessment of the reliability of astringency as a measure of salivary protein production and iron absorption.

The study has been conducted in an iron absorption study of 11 women, aged 18-35 years old, to determine iron bioavailability with supplementation of 0.03, 0.25, and 1.5 g 95% proanthocyanidin rich grape seed extract before and after regular, three times daily supplementation for four weeks. Each participant consumed all three concentrations of supplement over the 26-week study, with a two-week washout between interventions. 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. Astringency testing was conducted at the end of each meal challenge. 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 condensed tannin consumption on iron bioavailability and storage over time, at different doses. Data will also help to delineate possible physiological mechanisms underlying tannin 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 Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Iron Deficiency Anemia
  • Iron-deficiency
Intervention  ICMJE Dietary Supplement: 95% condensed proanthocyanidins from grape seed extract
0.03, 0.25, and 1.5 g 95% condensed proanthocyanidins from grape seed extract consumed three times daily for 4 weeks each
Study Arms  ICMJE
  • Experimental: 0.03 mg 95% condensed proanthocyanidin
    0.03 g 95% condensed proanthocyanidins from grape seed extract at week 0 0.03 g 95% condensed proanthocyanidins from grape seed extract at week 4
    Intervention: Dietary Supplement: 95% condensed proanthocyanidins from grape seed extract
  • Experimental: 0.25 g 95% condensed proanthocyanidin
    0.25 g 95% condensed proanthocyanidins from grape seed extract at week 0 0.25 g 95% condensed proanthocyanidins from grape seed extract at week 4
    Intervention: Dietary Supplement: 95% condensed proanthocyanidins from grape seed extract
  • Experimental: 1.5 g 95% condensed proanthocyanidin
    1.5 g 95% condensed proanthocyanidins from grape seed extract at week 0 1.5 g 95% condensed proanthocyanidins from grape seed extract at week 4
    Intervention: Dietary Supplement: 95% condensed proanthocyanidins from grape seed extract
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)
11
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 NCT03030716
Other Study ID Numbers  ICMJE PRPTanninTrial
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
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