Effect of Inulin on Iron Absorption in Humans

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier:
NCT01483092
First received: November 9, 2011
Last updated: June 6, 2013
Last verified: June 2013

November 9, 2011
June 6, 2013
August 2011
November 2011   (final data collection date for 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01483092 on ClinicalTrials.gov Archive Site
impact of inulin on the concentration of gut microbiota (bifidobacteria and total bacteria), SCFA and fecal pH in human subjects [ Time Frame: 3 month ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
Effect of Inulin on Iron Absorption in Humans
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.

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Iron Absorption
  • Gut Bacteria
  • Dietary Supplement: inulin
    20g/day for 4 weeks
  • Dietary Supplement: maltodextrin
    20g/day for 4 weeks
  • Experimental: inulin
    Intervention: Dietary Supplement: inulin
  • Placebo Comparator: maltodextrin
    Intervention: Dietary Supplement: maltodextrin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
January 2012
November 2011   (final data collection date for primary outcome measure)

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-
Female
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01483092
INOL
No
Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
Swiss Federal Institute of Technology
Not Provided
Principal Investigator: Richard Hurrell, Prof. Dr. ETH Zurich
Swiss Federal Institute of Technology
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP