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CompletedNCT01483092Updated Jun 7, 2013

Effect of Inulin on Iron Absorption in Humans

An interventional study of inulin and maltodextrin in Iron Absorption and Gut Bacteria, sponsored by Swiss Federal Institute of Technology. Completed at 1 site in Switzerland. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-06-07.

Sponsored by Swiss Federal Institute of Technology · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Iron Absorption
  • Gut Bacteria
03

In context

Lead sponsor

Swiss Federal Institute of Technology is the lead sponsor of 152 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • non-pregnant, non-lactating women
  • between 18 and 40 years
  • below 65kg

Exclusion criteria

Exclusion Criteria:

  • metabolic, chronic and gastro-intestinal disease
  • long-term medication
  • blood donation within 6 month before the study-
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    inulin

    Dietary Supplement: inulin

  • Placebo comparator
    maltodextrin

    Dietary Supplement: maltodextrin

Interventions

  • Dietary supplementinulin

    20g/day for 4 weeks

  • Dietary supplementmaltodextrin

    20g/day for 4 weeks

06

What researchers measure

Primary outcomes

  1. impact of inulin on iron absorption from standardized test meals, measured in humans by stable iron isotope technique

    Time frame: 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.

    Time frame: 3 month

07

Study locations

1 site
  • ETH
    Zürich, 8092, Switzerland
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 7, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01483092
Lead sponsor
Swiss Federal Institute of Technology
Responsible party
Prof. Michael B. Zimmermann (Prof., Swiss Federal Institute of Technology) — Principal investigator
First posted
Dec 1, 2011
Start date
Aug 2011
Primary completion
Nov 2011
Completion
Jan 2012
Last update
Jun 7, 2013

Study contacts

Richard Hurrell, Prof. Dr.
principal investigator · ETH Zurich

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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