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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 is a NA study that has completed, run by Kansas State University. The registered enrollment target is 11 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03030716
The ClinicalTrials.gov registry entry for NCT03030716 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kansas State University, which has 22 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which 95% condensed proanthocyanidins from grape seed extract is the first listed.
NCT03030716 reports 0 study locations.
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.
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