Effect of Inulin on Iron Absorption in Humans

Sponsor

Swiss Federal Institute of Technology (Other)

Overall Status

Completed

CT.gov ID

NCT01483092

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

6.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Iron Absorption Gut Bacteria	Dietary Supplement: inulin Dietary Supplement: maltodextrin	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, 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

Study Start Date :

Aug 1, 2011

Actual Primary Completion Date :

Nov 1, 2011

Actual Study Completion Date :

Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: inulin	Dietary Supplement: inulin 20g/day for 4 weeks
Placebo Comparator: maltodextrin	Dietary Supplement: maltodextrin 20g/day for 4 weeks

Arm

Intervention/Treatment

Experimental: inulin

Dietary Supplement: inulin

20g/day for 4 weeks

Placebo Comparator: maltodextrin

Dietary Supplement: maltodextrin

20g/day for 4 weeks

Outcome Measures

Primary Outcome Measures

impact of inulin on iron absorption from standardized test meals, measured in humans by stable iron isotope technique [3 month]

Secondary Outcome Measures

impact of inulin on the concentration of gut microbiota (bifidobacteria and total bacteria), SCFA and fecal pH in human subjects [3 month]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	ETH	Zürich		Switzerland	8092

Sponsors and Collaborators

Swiss Federal Institute of Technology

Investigators

Principal Investigator: Richard Hurrell, Prof. Dr., ETH Zurich

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Prof. Michael B. Zimmermann, Prof., Swiss Federal Institute of Technology

ClinicalTrials.gov Identifier:

NCT01483092

Other Study ID Numbers:

INOL

First Posted:

Dec 1, 2011

Last Update Posted:

Jun 7, 2013

Last Verified:

Jun 1, 2013

Study Results

No Results Posted as of Jun 7, 2013