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

Iron Deficiency Anemia Clinical 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03030716
• Other study ID #: PRPTanninTrial
• Status: Completed
• Phase: N/A
• First received: January 23, 2017
• Last updated: January 24, 2017
• Start date: June 25, 2016
• Est. completion date: December 10, 2016

Study information

• Verified date: January 2017
• Source: Kansas State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: December 10, 2016
• Est. primary completion date: December 10, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron Deficiency Anemia
• Iron-deficiency

Intervention

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

Locations

Country	Name	City	State
United States	Physical Activity and Nutrition Research Consortium	Manhattan	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Kansas State University	United States Department of Agriculture Foreign Agricultural Service

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline and 4 weeks
Primary	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	Baseline and 4 weeks
Primary	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	Baseline and 4 weeks