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NCT06021171 · ClinicalTrials.gov registry record · NA
Improving the Iron Status of Athletes With Pre-, Pro- and Synbiotics
A NA study of Iron Deficiency Anemia and Iron-deficiency, sponsored by King's College.
- Completed
- Registry status
- NA
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT06021171 is a NA study of Iron Deficiency Anemia and Iron-deficiency that has completed, run by King's College. The registered enrollment target is 10 participants, below the 193-participant average among 24 other Iron Deficiency Anemia trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06021171, a NA study of Iron Deficiency Anemia and Iron-deficiency, has completed, sponsored by King's College.
- COMPLETED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
Iron deficiency (ID) is the most common micronutrient deficiency worldwide, and poor iron bioavailability is a major cause. While 30% of female athletes are affected by ID, and its consequences are highly relevant to athletic performance, ID affects women and children around the world with consequences just as relevant, if not more so (e.g. school performance, work capacity and thus wage earning). With poor iron absorption being a cause of ID in active women, it is especially important to discover simple ways to improve iron (Fe) uptake. While some studies have suggested that consumption of prebiotic fiber may improve Fe absorption in animal models, there have been few studies examining the effects of synbiotic supplementation (consumption of both a prebiotic and probiotic that work together) on Fe uptake in adult females (athletes and non-athletes). A recent pilot study demonstrated a substantial improvement in Fe uptake in female athletes after 4 and 8 weeks of synbiotic supplementation compared to placebo during Fe repletion with a low dose of ferrous sulfate (FeSO4). If synbiotic supplementation can improve the Fe bioavailability of FeSO4 (which is \~30%) in ID women during repletion of Fe status, it could possibly improve the Fe bioavailability of non-heme Fe sources, as well as mixed meals. Research Question: What is the effect of synbiotic supplementation (a supplement containing a prebiotic + a probiotic), compared to prebiotic supplementation or a placebo, on Fe uptake and the gut microbiome in ID athletes during low-dose Fe repletion? Hypothesis: In the proposed study, we hypothesize that synbiotic supplementation along with Fe repletion with a low dose of FeSO4 will have greatest impact on athletes' Fe uptake due to alterations in the microbiome, which will be assessed.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Maltodextrin
- DIETARY_SUPPLEMENT Partially hydrolyzed guar gum + bifidobacterium lactis
- DIETARY_SUPPLEMENT Partially hydrolyzed guar gum
Study Locations (1)
Pennsylvania
- King's College - Wilkes-Barre
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2021-08-15 |
| Est. Completion | 2022-05-15 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06021171
The ClinicalTrials.gov registry entry for NCT06021171 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 193-participant average among 24 other Iron Deficiency Anemia trials with a reported enrollment target (95% lower). The listed sponsor is King's College, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Iron Deficiency Anemia appearing as the primary indexed condition, and to 3 interventions - of which Maltodextrin is the first listed.
NCT06021171 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06021171 about?
NCT06021171 is a clinical study titled "Improving the Iron Status of Athletes With Pre-, Pro- and Synbiotics". Iron deficiency (ID) is the most common micronutrient deficiency worldwide, and poor iron bioavailability is a major cause. While 30% of female athletes are affected by ID, and its consequences are highly relevant to athletic performance, ID affects women and children around the world with consequen...
What is the current status of trial NCT06021171?
This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2021-08-15. Estimated completion is 2022-05-15.
What conditions does trial NCT06021171 study?
This clinical trial studies the following conditions: Iron Deficiency Anemia, Iron-deficiency, Iron Deficiency (Without Anemia).
What interventions are being tested in trial NCT06021171?
The interventions under investigation include: Maltodextrin (DIETARY_SUPPLEMENT), Partially hydrolyzed guar gum + bifidobacterium lactis (DIETARY_SUPPLEMENT), Partially hydrolyzed guar gum (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT06021171?
This trial is sponsored by King's College, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06021171 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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