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

Primary Purpose

Iron Deficiency Anemia, Iron-deficiency

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
95% condensed proanthocyanidins from grape seed extract
Sponsored by
Kansas State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Iron Deficiency Anemia focused on measuring antinutrients, tannins, proanthocyanidins, salivary proline-rich proteins

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Physical Activity and Nutrition Research Consortium

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

0.03 mg 95% condensed proanthocyanidin

0.25 g 95% condensed proanthocyanidin

1.5 g 95% condensed proanthocyanidin

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Change in baseline to endline area under the curve after meal challenge at weeks 0 and 4 of each intervention
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
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
HPLC determination of salivary proteins will be analyzed from saliva collected before and after test meals at weeks 0 and 4 of each intervention

Secondary Outcome Measures

Full Information

First Posted
January 23, 2017
Last Updated
January 24, 2017
Sponsor
Kansas State University
Collaborators
United States Department of Agriculture Foreign Agricultural Service
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1. Study Identification

Unique Protocol Identification Number
NCT03030716
Brief Title
Multiple Daily Condensed Tannin Supplementation and Iron Bioavailability: The Tannin Dose Response Trial
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
June 25, 2016 (Actual)
Primary Completion Date
December 10, 2016 (Actual)
Study Completion Date
December 10, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kansas State University
Collaborators
United States Department of Agriculture Foreign Agricultural Service

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency Anemia, Iron-deficiency
Keywords
antinutrients, tannins, proanthocyanidins, salivary proline-rich proteins

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.03 mg 95% condensed proanthocyanidin
Arm Type
Experimental
Arm Description
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
Arm Title
0.25 g 95% condensed proanthocyanidin
Arm Type
Experimental
Arm Description
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
Arm Title
1.5 g 95% condensed proanthocyanidin
Arm Type
Experimental
Arm Description
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 Type
Dietary Supplement
Intervention Name(s)
95% condensed proanthocyanidins from grape seed extract
Intervention Description
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 Measure Information:
Title
Change in baseline to endline area under the curve after meal challenge at weeks 0 and 4 of each intervention
Description
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
Time Frame
Baseline and 4 weeks
Title
Change in baseline to endline hemoglobin and serum ferritin at weeks 0 and 4 of each intervention
Description
Change in ferritin and hemoglobin will be measured before administration of test meals at weeks 0 and 4
Time Frame
Baseline and 4 weeks
Title
Change in salivary proteins at weeks 0 and 4 of each intervention
Description
HPLC determination of salivary proteins will be analyzed from saliva collected before and after test meals at weeks 0 and 4 of each intervention
Time Frame
Baseline and 4 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian L Lindshield, Ph.D.
Organizational Affiliation
Kansas State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physical Activity and Nutrition Research Consortium
City
Manhattan
State/Province
Kansas
ZIP/Postal Code
66502
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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