Can Prebiotics Support the Treatment of Mild Iron Deficiency by Iron Supplementation

NCT03850652 | Unknown

• 1 other identifier: UREC 18/56
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The first aim of this study is to investigate if daily administration of the prebiotic Synergy-1 (a commercial product consisting of oligofructose-enriched inulin) together with a common iron supplement (ferrous sulphate) during 4 weeks, in premenopausal non-anaemic women with low ferritin levels, would mitigate the adverse effects of iron on the gut microbiota. The estimated absorption rate of the ferrous salts is 10-15%, therefore the unabsorbed iron will reach the colon where it could stimulate growth of non-beneficial bacterial species in the intestinal environment. By contrast, prebiotics function by specifically supporting growth of the typically-beneficial microorganism such as bifidobacteria. Inulin-type fructans (ITF) are well recognised in this way. The hypothesis to be tested is that prebiotic consumption will lead to a beneficial shift in the microbiota helping against the dysbiosis associated with iron supplementation.

Conditions

Healthy

Keywords

Iron Supplementation; Prebiotics; Microbiota

Outcome Measures

Primary Outcomes (5)

• Changes in the faecal microbiota composition by Next Generation Sequencing (NGS)

  Changes in composition of faecal microbiota attributable to prebiotic and iron intervention assessed by Next Generation Sequencing.

  12 weeks intervention

• Changes in the concentration (mcg/g) of faecal calprotectin (gut inflammatory marker) during iron intervention using enzyme-linked immunosorbent assays (ELISAs).

  Gut inflammation will be evaluated measuring concentration (mcg/g) of calprotectin. Elevated faecal calprotectin indicates the migration of neutrophils to the intestinal mucosa, which occurs during intestinal inflammation

  12 weeks intervention

• Changes in the concentration (pg/mL) of inflammatory markers in plasma during iron intervention using enzyme-linked immunosorbent assays (ELISAs).

  Gut inflammation will be also assessed measuring concentration (pg/mL) of gut inflammatory markers as plasma intestinal fatty acid-binding protein and cytokines from plasma (i.e interleukin 6, interleukin 10, tumor necrosis factor alpha). Samples will be analysed using enzyme-linked immunosorbent assays (ELISAs).

  12 weeks intervention

• Changes in faecal microbiota activity measured by using Nuclear magnetic resonance spectroscopy (NMR)

  Changes in the metabolic profile during the intervention will be measured in urine and faecal samples by NMR.

  12 weeks intervention

• Changes in faecal water genotoxicity of the volunteers during the intervention by comet assay (single cell gel electrophoresis assay using HT29 cells with Komet 5.5 software)

  Genotoxicity of volunteer faecal water will be measured at baseline and during intervention to determine whether prebiotic intervention can ameliorate iron-induced enterocyte genotoxicity. HT29 cells will be exposed to faecal waters, then single stranded breaks to the DNA will be quantified using Komet 5.5 software.

  12 weeks intervention

Secondary Outcomes (2)

• Daily assessment of stool consistency

  12 weeks intervention

• Daily assessment of gastrointestinal symptoms

  12 weeks intervention

Study Arms (2)

Prebiotic (Synergy-1)

ACTIVE COMPARATOR

Prebiotic (Synergy-1) + Iron supplement

Dietary Supplement: Prebiotic (Synergy-1) + Iron supplement

Maltodextrin

PLACEBO COMPARATOR

Placebo (Maltodextrin) + Iron Supplement

Dietary Supplement: Placebo (Maltodextrin) + Iron Supplement

Interventions

Prebiotic (Synergy-1) + Iron supplement DIETARY_SUPPLEMENT

In addition, participants will be required to take one 7 g sachet of prebiotic food supplement daily. In addition, participants will be required to take one daily tablet of a generic, iron supplement (200 mg FeSO4 equivalent to 65 mg iron) (provided by pharmacy).

Prebiotic (Synergy-1)

Placebo (Maltodextrin) + Iron Supplement DIETARY_SUPPLEMENT

participants will be required to take one 7 g sachet of placebo (maltodextrin) daily. In addition, participants will be required to take an iron supplement (200 mg FeSO4 equivalent to 65 mg iron) (provided by pharmacy).

Maltodextrin

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age: 18-50 years
• Gender: Female
• Volunteers agree to sign an informal written consent form
• General good health
• Have ferritin levels below 40 mcg/l
• Normal or borderline-low hemoglobin levels (\>11.5g/dL)

You may not qualify if:

• Use of antibiotics, prebiotics or probiotics (in food products or as supplements), laxatives, anti-spasmodic, anti-diarrhoea drugs, (e.g. Orlistat, Lactulose) in the last 4 weeks prior to, or during the study period.
• Use of any iron supplement in the last 6 months prior to the study period.
• If participants have received bowel preparation for investigative procedures in the 4 weeks prior to the study.
• Surgical resection of any part of the bowel.
• If participants are taking any medication whose effectiveness could be reduced by the iron administration (e.g. Levodopa, Levothyroxine).
• If participants have any chronic gut disorder/disease, such as inflammatory bowel syndrome (IBS), inflammatory bowel disease (IBD), etc. or other conditions that might affect the gut environment, e.g. coeliac disease.
• If participants are taking any medication that could affect the iron absorption (e.g. lansoprazole, omeprazole).
• If participants are pregnant or are lactating.
• If participants have a body mass index (BMI) \> 30 kg/m2.
• Severe allergy or any history of severe abnormal drug reaction, drug or alcohol abuse.

Sponsors & Collaborators

• Gemma Walton: lead
• Biotechnology and Biological Sciences Research Council: collaborator

Study Sites (1)

University of Reading

Reading, RG6 6AP, United Kingdom

RECRUITING

MeSH Terms

Interventions

Prebiotics; Iron-Dextran Complex; maltodextrin

Intervention Hierarchy (Ancestors)

Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Dietary Supplements; Food and Beverages; Coordination Complexes; Organic Chemicals; Dextrans; Glucans

Study Officials

• Simon C Andrews, PhD

  University of Reading

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Monteagudo, PhD

CONTACT

+44 (0) 118 378 7713; a.montegudo@reading.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer in Metagenomics; Principal Investigator

Study Record Dates

• First Submitted: February 13, 2019
• First Posted: February 22, 2019
• Study Start: March 6, 2019
• Primary Completion: October 1, 2019
• Study Completion: January 1, 2020
• Last Updated: March 6, 2019

Record last verified: 2019-03

Locations

GB (1)