HealthyNCT03850652
Can Prebiotics Support the Treatment of Mild Iron Deficiency by Iron Supplementation
A study testing Prebiotic (Synergy-1) + Iron supplement in people with Healthy, run by Gemma Walton at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Prebiotic (Synergy-1) + Iron supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Mar 2019to 1 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Reading
Reading, RG6 6AP
Andrea Monteagudo, PhD, +44 (0) 118 378 7713, a.monteagudo@reading.ac.uk
PhD
About this study
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.
Read the detailed description
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.
- Conditions
- Healthy
- Being tested
- Prebiotic (Synergy-1) + Iron supplement, Placebo (Maltodextrin) + Iron Supplement
- Keywords
- Iron Supplementation, Prebiotics, Microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prebiotic (Synergy-1) + Iron supplementDietary 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 (Maltodextrin) + Iron SupplementDietary 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).
| Study group | Role | What they receive |
|---|---|---|
| Prebiotic (Synergy-1) | Active comparator | Prebiotic (Synergy-1) + Iron supplement Receives: Dietary Supplement: Prebiotic (Synergy-1) + Iron supplement |
| Maltodextrin | Placebo comparator | Placebo (Maltodextrin) + Iron Supplement Receives: Dietary Supplement: Placebo (Maltodextrin) + Iron Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 12 weeks intervention
Secondary outcomes (2)
Daily assessment of stool consistency
Volunteers will keep a daily diary noting the consistency of the stools using the Bristol stool chart.
Measured: 12 weeks intervention
Daily assessment of gastrointestinal symptoms
Volunteers will keep a daily diary recording abnormal pain, bloating or flatulence
Measured: 12 weeks intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study start6 Mar 2019 (estimated)
- Primary completion1 Oct 2019 (estimated)
- Study completion1 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gemma Walton
- Sponsor type
- University, hospital or other
- Collaborators
- Biotechnology and Biological Sciences Research Council
- Responsible party
- Sponsor-investigator, Gemma Walton, University of Reading
- Investigators
- Simon C Andrews, PhD, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03850652
- Sponsor's protocol ID
- UREC 18/56
- Status last verified
- Mar 2019
- First submitted
- 13 Feb 2019
- Last updated
- 6 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymised data of faecal bacterial DNA may be made available to The European Bioinformatics Institute. This will help support other research in the field
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Prebiotics Support the Treatment of Mild Iron Deficiency by Iron Supplementation
- ClinicalTrials.gov ID
- NCT03850652
- Acronym / sponsor ID
- UREC 18/56
- Conditions
- Healthy
- Keywords
- Iron Supplementation, Prebiotics, Microbiota
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Gemma WaltonUniversity, hospital or other
- Collaborators
- Biotechnology and Biological Sciences Research Council
- Study start
- 6 Mar 2019 (estimated)
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 22 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prebiotic (Synergy-1) | Active comparator | Dietary Supplement: Prebiotic (Synergy-1) + Iron supplementPrebiotic (Synergy-1) + Iron supplement |
| Maltodextrin | Placebo comparator | Dietary Supplement: Placebo (Maltodextrin) + Iron SupplementPlacebo (Maltodextrin) + Iron Supplement |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prebiotic (Synergy-1) + Iron supplementIn 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). | Dietary supplement | Prebiotic (Synergy-1) |
| Placebo (Maltodextrin) + Iron Supplementparticipants 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). | Dietary supplement | Maltodextrin |
Primary outcome
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.
2 secondary outcomes
Daily assessment of stool consistency
Time frame: 12 weeks intervention
Daily assessment of gastrointestinal symptoms
Time frame: 12 weeks intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2019.
- Individual participant dataSharing planned: Undecided. Anonymised data of faecal bacterial DNA may be made available to The European Bioinformatics Institute. This will help support other research in the field
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon C Andrews, PhD principal investigator
University of Reading
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prebiotic (Synergy-1) + Iron supplement in people with Healthy, run by Gemma Walton at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Monteagudo, PhD (+44 (0) 118 378 7713, a.montegudo@reading.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the faecal microbiota composition by Next Generation Sequencing (NGS) (time frame: 12 weeks intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2019.