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

NCT06021171 | Completed

• 1 other identifier: 2021-44-0701
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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)

Outcome Measures

Primary Outcomes (4)

• Blood serum level of ferritin

  biomarker of iron status, iron stores, use to calculate Total body iron

  baseline (0), 4, 8, 12, 16, 18 weeks

• Blood level of hemoglobin

  biomarker of iron status

  baseline (0), 4, 8, 12, 16, 18 weeks

• Blood serum level of soluble transferrin receptor

  biomarker of iron status, tissue iron status, use to calculate Total body iron

  baseline (0), 4, 8, 12, 16, 18 weeks

• Gut microbiome data

  Fecal samples to yield gut bacterial taxa

  baseline (0), 4, 8, 12, 16, 18 weeks

Study Arms (3)

Regular Girl (Sunfiber + Bifidobacterium lactis)

ACTIVE COMPARATOR

Regular Girl, a synbiotic supplement containing the Prebiotic Sunfiber + Bifidobacterium Lactis

Dietary Supplement: Partially hydrolyzed guar gum + bifidobacterium lactis

Maltodextrin

PLACEBO COMPARATOR

Maltodextrin

Dietary Supplement: Maltodextrin

Sunfiber

ACTIVE COMPARATOR

SunFiber, a prebiotic fiber supplement

Dietary Supplement: Partially hydrolyzed guar gum

Interventions

Partially hydrolyzed guar gum + bifidobacterium lactis DIETARY_SUPPLEMENT

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

Also known as: RegularGirl

Regular Girl (Sunfiber + Bifidobacterium lactis)

Partially hydrolyzed guar gum DIETARY_SUPPLEMENT

5 g Partially hydrolyzed guar gum

Also known as: SunFiber

Sunfiber

Maltodextrin DIETARY_SUPPLEMENT

5 g Maltodextrin

Maltodextrin

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years of age or older
• currently participating in or training for their sport

You may not qualify if:

• Pregnant, or wishing to become pregnant
• Breastfeeding
• Having a condition or taking medication impacting iron status
• Not healthy enough to train for/participate in their sport.

Sponsors & Collaborators

• King's College: lead

Study Sites (1)

King's College

Wilkes-Barre, Pennsylvania, 18711, United States

Location

Related Publications (7)

• DellaValle DM, Haas JD. Impact of iron depletion without anemia on performance in trained endurance athletes at the beginning of a training season: a study of female collegiate rowers. Int J Sport Nutr Exerc Metab. 2011 Dec;21(6):501-6. doi: 10.1123/ijsnem.21.6.501.

  PMID: 22089308 BACKGROUND

• Dellavalle DM, Haas JD. Iron status is associated with endurance performance and training in female rowers. Med Sci Sports Exerc. 2012 Aug;44(8):1552-9. doi: 10.1249/MSS.0b013e3182517ceb.

  PMID: 22382172 BACKGROUND

• Sandroni A, House E, Howard L, DellaValle DM. Synbiotic Supplementation Improves Response to Iron Supplementation in Female Athletes during Training. J Diet Suppl. 2022;19(3):366-380. doi: 10.1080/19390211.2021.1887423. Epub 2021 Feb 22.

  PMID: 33615951 BACKGROUND

• DellaValle DM, Glahn RP, Shaff JE, O'Brien KO. Iron Absorption from an Intrinsically Labeled Lentil Meal Is Low but Upregulated in Women with Poor Iron Status. J Nutr. 2015 Oct;145(10):2253-7. doi: 10.3945/jn.115.217273. Epub 2015 Sep 2.

  PMID: 26338889 BACKGROUND

• Scholz-Ahrens KE, Schrezenmeir J. Inulin and oligofructose and mineral metabolism: the evidence from animal trials. J Nutr. 2007 Nov;137(11 Suppl):2513S-2523S. doi: 10.1093/jn/137.11.2513S.

  PMID: 17951495 BACKGROUND

• Freitas Kde C, Amancio OM, de Morais MB. High-performance inulin and oligofructose prebiotics increase the intestinal absorption of iron in rats with iron deficiency anaemia during the growth phase. Br J Nutr. 2012 Sep 28;108(6):1008-16. doi: 10.1017/S0007114511006301. Epub 2011 Dec 15.

  PMID: 22172251 BACKGROUND

• Laparra JM, Diez-Municio M, Herrero M, Moreno FJ. Structural differences of prebiotic oligosaccharides influence their capability to enhance iron absorption in deficient rats. Food Funct. 2014 Oct;5(10):2430-7. doi: 10.1039/c4fo00504j. Epub 2014 Aug 11.

  PMID: 25109275 BACKGROUND

Related Links

• Website for RegularGirl Product
• Website for SunFiber Product

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Iron Deficiencies

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Diane M. DellaValle

  King's College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Volunteers will be asked to mix the powder packet (e.g. supplemental functional fiber source or placebo), with any food or beverage once daily. All 3 powders are identically packaged and only visible as white powder, and all 3 powders are colorless, odorless and tasteless when mixed in a liquid or semi-solid food. Instructions and education to both groups will be identical. Packets were sent to the Researcher pre-packaged and pre-labeled as A, B, C by the product company. Subject randomization to treatment order was completed using random number generator by a Research Assistant not involved in direct contact with subjects.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Research Dietitian

Model Details: This is a double-blind, randomized, placebo-controlled crossover trial.

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: September 1, 2023
• Study Start: August 15, 2021
• Primary Completion: May 15, 2022
• Study Completion: May 15, 2022
• Last Updated: September 1, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact dianedellavalle@kings.edu.

Locations

US (1)