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

Not Applicable

Completed

• Conditions: Iron Deficiency Anemia; Iron-deficiency
• Interventions: Dietary Supplement: 95% condensed proanthocyanidins from grape seed extract

• Registration Number: NCT03030716
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-25
• Primary Completion: 2016-12-10
• Study Completion: 2016-12-10
• Status Verified: 2017-01
• Study First Submitted: 2017-01-23
• Study First Submitted QC: 2017-01-24
• Last Update Submitted: 2017-01-24
• Study First Posted: 2017-01-25
• Last Update Posted: 2017-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 11

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1.5 g 95% condensed proanthocyanidin	95% condensed proanthocyanidins from grape seed extract	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
0.25 g 95% condensed proanthocyanidin	95% condensed proanthocyanidins from grape seed extract	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
0.03 mg 95% condensed proanthocyanidin	95% condensed proanthocyanidins from grape seed extract	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

Primary Outcome Measures

Name	Time	Method
Change in baseline to endline area under the curve after meal challenge at weeks 0 and 4 of each intervention	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 salivary proteins at weeks 0 and 4 of each intervention	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
Change in baseline to endline hemoglobin and serum ferritin at weeks 0 and 4 of each intervention	Baseline and 4 weeks	Change in ferritin and hemoglobin will be measured before administration of test meals at weeks 0 and 4

Trial Locations

Locations (1)

Physical Activity and Nutrition Research Consortium; 🇺🇸 Manhattan, Kansas, United States