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
  Purpose

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.


Condition Intervention
Iron Absorption
Gut Bacteria
Dietary Supplement: inulin
Dietary Supplement: maltodextrin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Inulin Modifies Gut Microbiota, Fecal Lactate Concentration and Fecal pH But Does Not Influence Iron Absorption in Women With Low Iron Status

Resource links provided by NLM:


Further study details as provided by Swiss Federal Institute of Technology:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Enrollment: 32
Study Start Date: August 2011
Study Completion Date: January 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: inulin Dietary Supplement: inulin
20g/day for 4 weeks
Placebo Comparator: maltodextrin Dietary Supplement: maltodextrin
20g/day for 4 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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-
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01483092

Locations
Switzerland
ETH
Zürich, Switzerland, 8092
Sponsors and Collaborators
Swiss Federal Institute of Technology
Investigators
Principal Investigator: Richard Hurrell, Prof. Dr. ETH Zurich
  More Information

No publications provided

Responsible Party: Prof. Michael B. Zimmermann, Prof., Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier: NCT01483092     History of Changes
Other Study ID Numbers: INOL
Study First Received: November 9, 2011
Last Updated: June 6, 2013
Health Authority: Switzerland: Ethikkommission

ClinicalTrials.gov processed this record on October 30, 2014