Improving the Iron Status of Athletes With Pre-, Pro- and Synbiotics
NCT06021171 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2023-09-01
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
- Iron-deficiency
- Iron Deficiency Anemia
- Iron Deficiency (Without Anemia)
Interventions
- DIETARY_SUPPLEMENT
-
Partially hydrolyzed guar gum + bifidobacterium lactis
Synbiotic Supplement: Contains 5 grams of prebiotic fiber (Sunfiber®) and 8 billion active probiotics (Bifidobacterium lactis).
- DIETARY_SUPPLEMENT
-
Partially hydrolyzed guar gum
5 g Partially hydrolyzed guar gum
- DIETARY_SUPPLEMENT
-
Maltodextrin
5 g Maltodextrin
Sponsors & Collaborators
-
King's College
lead OTHER
Principal Investigators
-
Diane M. DellaValle · King's College
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 35 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-08-15
- Primary Completion
- 2022-05-15
- Completion
- 2022-05-15
Countries
- United States
Study Locations
More Related Trials
-
Iron Bioavailability From Cubes
NCT02327299 ·Status: COMPLETED ·Phase: NA
-
Iron Absorption From an Iron-fortified Follow-up Formula With Added Synbiotic or Human Milk Oligosaccharides
NCT04774016 ·Status: COMPLETED ·Phase: NA
-
Iron Aid IPS on Performance, Fatigue and Iron Levels During 12 Weeks of Supplementation and Aerobic Training
NCT03523455 ·Status: TERMINATED ·Phase: NA
-
Healthy Infant Development Project
NCT00613717 ·Status: COMPLETED ·Phase: NA
-
Iron and Prebiotics Fortification in Kenyan Infants
NCT02118402 ·Status: COMPLETED ·Phase: NA
-
Heme and Non-heme Iron Intakes, Gut Microbiota, and Influence on Host Iron Absorption
NCT06146608 ·Status: RECRUITING
-
Trial of Pre-Pregnancy Supplements
NCT01183572 ·Status: COMPLETED ·Phase: NA
-
Probing the Synergistic Effect of Pre-Biotics & Iron Fortificants in Anemic Subjects
NCT03894449 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
The Acute Effects Fortified Nutritional Supplementation on Childhood Cognition
NCT02630667 ·Status: COMPLETED ·Phase: NA
-
Determination of a Dose-dependent Effect of GOS on Iron Absorption, and Addition of Vitamin C
NCT03762148 ·Status: COMPLETED ·Phase: NA
-
Impact of Low Dose Iron-containing Micronutrient Powders on Iron Status and Morbidity of Young Children in Ethiopia
NCT02479815 ·Status: COMPLETED ·Phase: NA
-
Prebiotic GOS and Lactoferrin With Iron Supplements
NCT03866837 ·Status: COMPLETED ·Phase: NA
-
Iron Bioavailability From MyPyramid Menus
NCT00754234 ·Status: COMPLETED ·Phase: NA
-
Iron Absorption From a Micronutrient Powder Containing Galacto-oligosaccharides (GOS)
NCT02666417 ·Status: COMPLETED ·Phase: NA
-
Efficacy Evaluation of 16 Weeks' Dietary Supplementation With Iron Bis-glycinate Plus Vitamin C on Cognitive Function, Subjective Mood, Fatigue, Health and Well-being
NCT04469010 ·Status: COMPLETED ·Phase: NA
-
Iron Bioavailability From Fortified Food
NCT02993835 ·Status: COMPLETED ·Phase: NA
-
The Effect of Different Prebiotics on Iron Absorption From High Dose Iron Supplements
NCT04194255 ·Status: COMPLETED ·Phase: NA
-
Enhancing Treatment of Iron Deficiency and Iron Deficiency Anemia With an Antioxidant, Vitamin E
NCT01700426 ·Status: COMPLETED ·Phase: PHASE1
-
Efficacy of Recombinant Bovine Lactoferrin (rbLf) in Iron Regulation
NCT06428357 ·Status: COMPLETED ·Phase: NA
-
16 Weeks' Dietary Supplementation With Iron and Iron + Vitamin C on Cerebral Blood Flow and Energy Expenditure in Women of Reproductive Age
NCT04477018 ·Status: COMPLETED ·Phase: NA
-
Iron Bioavailability of Fortified Oat Drink
NCT01423162 ·Status: COMPLETED ·Phase: PHASE4
-
Treatment of Anemia in the 2nd Year of Life. Comparison of the Efficacy of Two Different Iron Preparations.
NCT00248716 ·Status: UNKNOWN ·Phase: PHASE4
-
Effect of Household Use of Multiple Micronutrient-fortified Bouillon on Micronutrient Status Among Women and Children in Two Districts in the Northern Region of Ghana
NCT05178407 ·Status: COMPLETED ·Phase: NA
-
Efficacy Trial to Examine Efficacy of Multimicronutrient Home Supplementation in Infants
NCT00276198 ·Status: COMPLETED ·Phase: PHASE3
-
Changes in Microbiota and Iron Status After Iron Fortification of Complementary Foods
NCT01111864 ·Status: COMPLETED ·Phase: NA