Clinical trial NCT01483092: Effect of Inulin on Iron Absorption in Humans
Official title: Inulin Modifies Gut Microbiota, Fecal Lactate Concentration and Fecal pH But Does Not Influence Iron Absorption in Women With Low Iron Status
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Absorption
Gut Bacteria
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
First posted: 2011-12-01
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: impact of inulin on iron absorption from standardized test meals, measured in humans by stable iron isotope technique
timeFrame: 3 month
Secondary outcomes:
measure: impact of inulin on the concentration of gut microbiota (bifidobacteria and total bacteria), SCFA and fecal pH in human subjects
timeFrame: 3 month
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: ETH
Study officials:
affiliation: ETH Zurich
name: Richard Hurrell, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.