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NCT03030716 · ClinicalTrials.gov registry record · NA
Multiple Daily Condensed Tannin Supplementation and Iron Bioavailability: The Tannin Dose Response Trial
A NA study, sponsored by Kansas State University.
- Completed
- Registry status
- NA
- Development phase
- 11
- Enrollment target
NCT03030716: Completed NA study, sponsored by Kansas State University.
NCT03030716 is a NA study that has completed, run by Kansas State University. The registered enrollment target is 11 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03030716, a NA study, has completed, sponsored by Kansas State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 11 participants
- Enrollment target
Study 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
Primary Outcome
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
Interventions
- DIETARY_SUPPLEMENT 95% condensed proanthocyanidins from grape seed extract
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2016-06-25 |
| Est. Completion | 2016-12-10 |
| Phase | NA |
What the finished NCT03030716 record still lists
NCT03030716 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which 95% condensed proanthocyanidins from grape seed extract is the first listed.
NCT03030716 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03030716 about?
NCT03030716 is a clinical study titled "Multiple Daily Condensed Tannin Supplementation and Iron Bioavailability: The Tannin Dose Response Trial". 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 in...
What is the current status of trial NCT03030716?
This trial is currently completed. It is a NA study. The enrollment target is 11 participants. The study started on 2016-06-25. Estimated completion is 2016-12-10.
What interventions are being tested in trial NCT03030716?
The interventions under investigation include: 95% condensed proanthocyanidins from grape seed extract (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03030716?
This trial is sponsored by Kansas State University, which has 22 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03030716's enrollment target sits among peer trials
11 1927th of 2000 higher than 74 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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