NCT01483092

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2011

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

June 7, 2013

Status Verified

June 1, 2013

Enrollment Period

3 months

First QC Date

November 9, 2011

Last Update Submit

June 6, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

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

    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

    3 month

Study Arms (2)

inulin

EXPERIMENTAL
Dietary Supplement: inulin

maltodextrin

PLACEBO COMPARATOR
Dietary Supplement: maltodextrin

Interventions

inulinDIETARY_SUPPLEMENT

20g/day for 4 weeks

inulin
maltodextrinDIETARY_SUPPLEMENT

20g/day for 4 weeks

maltodextrin

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ETH

Zurich, Canton of Zurich, 8092, Switzerland

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Inulinmaltodextrin

Intervention Hierarchy (Ancestors)

StarchGlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesFructansPolysaccharides

Study Officials

  • Richard Hurrell, Prof. Dr.

    ETH Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

November 9, 2011

First Posted

December 1, 2011

Study Start

August 1, 2011

Primary Completion

November 1, 2011

Study Completion

January 1, 2012

Last Updated

June 7, 2013

Record last verified: 2013-06

Locations