CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 10 enrolled
Drug / intervention
Partially hydrolyzed guar gum + bifidobacterium lactis +2 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06021171
NCT06021171N/ACompleted

Improving the Iron Status of Athletes With Pre-, Pro- and Synbiotics

King's College·interventional·Posted Sep 1, 2023·Updated Sep 1, 2023

In Brief

A clinical study evaluating Partially hydrolyzed guar gum + bifidobacterium lactis, Partially hydrolyzed guar gum, and 1 other intervention for Iron-deficiency and 2 related conditions. Completed, enrolled 10 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedSep 1, 2023
Enrollment StartAug 15, 2021
Primary CompletionMay 15, 2022
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 2.8 years ago

Interventions

Partially hydrolyzed guar gum + bifidobacterium lactisdietary

Synbiotic Supplement: Contains 5 grams of prebiotic fiber (Sunfiber®) and 8 billion active probiotics (Bifidobacterium lactis).

Partially hydrolyzed guar gumdietary

5 g Partially hydrolyzed guar gum

Maltodextrindietary

5 g Maltodextrin