Can Prebiotics Support the Treatment of Mild Iron Deficiency by Iron Supplementation
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|ClinicalTrials.gov Identifier: NCT03850652|
Recruitment Status : Recruiting
First Posted : February 22, 2019
Last Update Posted : March 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Dietary Supplement: Prebiotic (Synergy-1) + Iron supplement Dietary Supplement: Placebo (Maltodextrin) + Iron Supplement||Not Applicable|
This will be a crossover, placebo controlled, and randomised pilot study in 15 pre-menopausal female individuals with ferritin levels below 40 mcg/l but normal hemoglobin (Hb) and C reactive protein (CRP). The study will last 12 weeks and consist of two separated 4-week randomised intervention treatment periods with a prebiotic (Synergy-1) or placebo (Maltodextrin) in combination with an iron supplement (FeSO4) separated by a 4-week wash-out period. Volunteers will take daily doses of an iron supplement and a prebiotic (Synergy-1) or placebo (Maltodextrin) during the trial excepting in the washout period where the iron supplement and prebiotic/placebo treatments will be discontinued.
This trial will investigate the effects of an iron supplement treatment in combination with a prebiotic food supplement or placebo food supplement. 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). In addition, participants will be required to take one of the products (prebiotic or placebo) daily at the same time each day. The prebiotic food supplement (supplied by the Beneo company) is a chicory inulin powder produced in Belgium. It has been used in scores of human intervention studies with no adverse effects. Participants will be required to take one 7 g sachet of prebiotic food supplement daily. This will be reconstituted with water and participants will be encouraged to take the sachet at the same time each day. The placebo control food supplement will be maltodextrin. Maltodextrin is a standard placebo product for use in human studies involving prebiotics and has been used safely at this dose, in many trials by ourselves for the last 20 years. The products will be provided as a powder (served in sachets) and identical in texture and appearance. The Beneo company will produce and provide barcoded sachets, blinded to the investigators and volunteers. After all volunteers have completed their study visits and all samples have been analysed by researchers, Beneo will provide information about barcoded sachets. Compliance to food supplement (prebiotic or placebo) will be assessed by recording intake in gastrointestinal (GI) diaries and participants will also be asked to return any unused sachets to the researchers at the end of the each 4-week intervention periods. For participants to be considered compliant and therefore included in the study, they will be required to take the food supplement or placebo at least 6 out of every 7 days of the trial for the week period and return completed questionnaires.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Can Prebiotics Support the Treatment of Mild Iron Deficiency by Iron Supplementation|
|Estimated Study Start Date :||March 6, 2019|
|Estimated Primary Completion Date :||October 1, 2019|
|Estimated Study Completion Date :||January 1, 2020|
Active Comparator: Prebiotic (Synergy-1)
Prebiotic (Synergy-1) + Iron supplement
Dietary Supplement: Prebiotic (Synergy-1) + Iron 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).
Placebo Comparator: Maltodextrin
Placebo (Maltodextrin) + Iron Supplement
Dietary Supplement: Placebo (Maltodextrin) + Iron 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).
- Changes in the faecal microbiota composition by Next Generation Sequencing (NGS) [ Time Frame: 12 weeks intervention ]Changes in composition of faecal microbiota attributable to prebiotic and iron intervention assessed by Next Generation Sequencing.
- Changes in the concentration (mcg/g) of faecal calprotectin (gut inflammatory marker) during iron intervention using enzyme-linked immunosorbent assays (ELISAs). [ Time Frame: 12 weeks intervention ]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
- Changes in the concentration (pg/mL) of inflammatory markers in plasma during iron intervention using enzyme-linked immunosorbent assays (ELISAs). [ Time Frame: 12 weeks intervention ]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).
- Changes in faecal microbiota activity measured by using Nuclear magnetic resonance spectroscopy (NMR) [ Time Frame: 12 weeks intervention ]Changes in the metabolic profile during the intervention will be measured in urine and faecal samples by NMR.
- 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) [ Time Frame: 12 weeks intervention ]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.
- Daily assessment of stool consistency [ Time Frame: 12 weeks intervention ]Volunteers will keep a daily diary noting the consistency of the stools using the Bristol stool chart.
- Daily assessment of gastrointestinal symptoms [ Time Frame: 12 weeks intervention ]Volunteers will keep a daily diary recording abnormal pain, bloating or flatulence
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03850652
|Contact: Andrea Monteagudo, PhD||+44 (0) 118 378 email@example.com|
|University of Reading||Recruiting|
|Reading, United Kingdom, RG6 6AP|
|Contact: Andrea Monteagudo, PhD +44 (0) 118 378 7713 firstname.lastname@example.org|
|Contact: , PhD|
|Principal Investigator: Gemma E Walton, PhD, BSc|
|Sub-Investigator: Andrea Monteagudo, PhD, BSc|
|Principal Investigator: Simon Andrews, PhD, BSc|
|Principal Investigator:||Simon C Andrews, PhD||University of Reading|