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Trial record 67 of 750 for:    Area Under Curve AND meal

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

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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

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.


Condition or disease Intervention/treatment Phase
Iron Deficiency Anemia Iron-deficiency Dietary Supplement: 95% condensed proanthocyanidins from grape seed extract Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Long-term, Multiple Daily Condensed Tannin Supplementation in Increasing Concentrations Does Not Affect Iron Status or Bioavailability: Results From the Tannin-dose Response Trial.
Actual Study Start Date : June 25, 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

Arm Intervention/treatment
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
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

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
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

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
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




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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



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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): NCT03030716


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
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: NCT03030716     History of Changes
Other Study ID Numbers: PRPTanninTrial
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:
antinutrients
tannins
proanthocyanidins
salivary proline-rich proteins
Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Proanthocyanidin
Grape Seed Extract
Benzocaine
Procyanidin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents