Iron AbsorptionNCT01483092
Effect of Inulin on Iron Absorption in Humans
A study testing inulin and maltodextrin in people with Iron Absorption and Gut Bacteria, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
Trial summary
Prebiotics are non-digestible food ingredients that beneficially affect the host by selectively stimulating the growth or activity of species in the colon that can improve host health. Inulin-type fructans (inulin and oligofructose) are natural food ingredients with prebiotic activity. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Absorption, Gut Bacteria
- What is being tested?
- inulin and maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2011to Jan 2012
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- non-pregnant, non-lactating women
- between 18 and 40 years
- below 65kg
Who cannot join
- metabolic, chronic and gastro-intestinal disease
- long-term medication
- blood donation within 6 month before the study-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Inulin Modifies Gut Microbiota, Fecal Lactate Concentration and Fecal pH But Does Not Influence Iron Absorption in Women With Low Iron Status
Prebiotics are non-digestible food ingredients that beneficially affect the host by selectively stimulating the growth or activity of species in the colon that can improve host health.
Inulin-type fructans (inulin and oligofructose) are natural food ingredients with prebiotic activity. Fermentation of inulin and oligofructose by lactic acid producing bacteria results in an increase in bacterial biomass and the production of SCFA (acetate, propionate and butyrate), lactic acid and the gases CO2 and H2. They are naturally present in significant amounts in several vegetables such as garlic, artichoke, onion, asparagus, leek and wheat (1-4%). Based on consumption data, the daily intake of inulin in Europe varies between 3.2 and 11.3g mainly from wheat (2-7.8g/d). However, this might have changed recently since inulin and oligofructose are used by the food industry either as sucrose and fat replacements or due to their health benefits for the human host.
Read more
Several human absorption studies evaluated the effect of inulin/oligofructose on mineral absorption. It was shown that calcium and magnesium absorption was positively influenced. Until now, the positive effect on iron absorption was only shown in animals. The influence on human iron absorption was investigated twice. Both studies reported no effect of inulin/oligofructose on iron absorption, but this was most likely due to poorly conceived study designs.
The aim of the present study is to demonstrate that inulin consumption over several weeks can lead to enhanced iron absorption in humans under optimized conditions.
- Conditions
- Iron Absorption, Gut Bacteria
- Being tested
- inulin, maltodextrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inulinDietary supplement
20g/day for 4 weeks
maltodextrinDietary supplement
20g/day for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| inulin | Experimental | Not described Receives: Dietary Supplement: inulin |
| maltodextrin | Placebo comparator | Not described Receives: Dietary Supplement: maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
impact of inulin on iron absorption from standardized test meals, measured in humans by stable iron isotope technique
Measured: 3 month
Secondary outcomes (1)
impact of inulin on the concentration of gut microbiota (bifidobacteria and total bacteria), SCFA and fecal pH in human subjects
Concentration of bifidobacteria, total bacteria, SCFA (acetate, propionate, butyrate, formate), lactate, and pH will be measured (in the fecal samples of study participants) and compared between baseline, inulin period and placebo period. The pH of fecal sqamples will be measured using a digital pH meter. HPLC measurements will be done for the determination of SCFA and lactate. DNA amplification and detection will be done by quantitative PCR.
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2011 (estimated)
- Study startAug 2011
- Primary completionNov 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iron AbsorptionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
- Investigators
- Richard Hurrell, Prof. Dr., Principal investigator, ETH Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01483092
- Sponsor's protocol ID
- INOL
- Status last verified
- Jun 2013
- First submitted
- 9 Nov 2011
- Last updated
- 7 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Petry N, Egli I, Chassard C, Lacroix C, Hurrell R. Inulin modifies the bifidobacteria population, fecal lactate concentration, and fecal pH but does not influence iron absorption in women with low iron status. Am J Clin Nutr. 2012 Aug;96(2):325-31. doi: 10.3945/ajcn.112.035717. Epub 2012 Jun 27.
PubMed 22743314
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inulin Modifies Gut Microbiota, Fecal Lactate Concentration and Fecal pH But Does Not Influence Iron Absorption in Women With Low Iron Status
- ClinicalTrials.gov ID
- NCT01483092
- Acronym / sponsor ID
- INOL
- Conditions
- Iron Absorption, Gut Bacteria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 1 Dec 2011 (estimated)
- 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.
Prebiotics are non-digestible food ingredients that beneficially affect the host by selectively stimulating the growth or activity of species in the colon that can improve host health.
Inulin-type fructans (inulin and oligofructose) are natural food ingredients with prebiotic activity. Fermentation of inulin and oligofructose by lactic acid producing bacteria results in an increase in bacterial biomass and the production of SCFA (acetate, propionate and butyrate), lactic acid and the gases CO2 and H2. They are naturally present in significant amounts in several vegetables such as garlic, artichoke, onion, asparagus, leek and wheat (1-4%). Based on consumption data, the daily intake of inulin in Europe varies between 3.2 and 11.3g mainly from wheat (2-7.8g/d). However, this might have changed recently since inulin and oligofructose are used by the food industry either as sucrose and fat replacements or due to their health benefits for the human host.
Several human absorption studies evaluated the effect of inulin/oligofructose on mineral absorption. It was shown that calcium and magnesium absorption was positively influenced. Until now, the positive effect on iron absorption was only shown in animals. The influence on human iron absorption was investigated twice. Both studies reported no effect of inulin/oligofructose on iron absorption, but this was most likely due to poorly conceived study designs.
The aim of the present study is to demonstrate that inulin consumption over several weeks can lead to enhanced iron absorption in humans under optimized conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| inulin | Experimental | Dietary Supplement: inulin |
| maltodextrin | Placebo comparator | Dietary Supplement: maltodextrin |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- non-pregnant, non-lactating women
- between 18 and 40 years
- below 65kg
Key exclusion criteria (3 listed)
- metabolic, chronic and gastro-intestinal disease
- long-term medication
- blood donation within 6 month before the study-
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 |
|---|---|---|
| inulin20g/day for 4 weeks | Dietary supplement | inulin |
| maltodextrin20g/day for 4 weeks | Dietary supplement | maltodextrin |
Primary outcome
impact of inulin on iron absorption from standardized test meals, measured in humans by stable iron isotope technique
Time frame: 3 month
1 secondary outcome
impact of inulin on the concentration of gut microbiota (bifidobacteria and total bacteria), SCFA and fecal pH in human subjects
Time frame: 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2013.
- Derived from this study: PubMed 22743314Petry N, Egli I, Chassard C, Lacroix C, Hurrell R. Inulin modifies the bifidobacteria population, fecal lactate concentration, and fecal pH but does not influence iron absorption in women with low iron status. Am J Clin Nutr. 2012 Aug;96(2):325-31. doi: 10.3945/ajcn.112.035717. Epub 2012 Jun 27.
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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.
Richard Hurrell, Prof. Dr. principal investigator
ETH Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inulin and maltodextrin in people with Iron Absorption and Gut Bacteria, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 7 Jun 2013. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
impact of inulin on iron absorption from standardized test meals, measured in humans by stable iron isotope technique (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01483092, which also lists 1 linked publication.
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 7 Jun 2013.