CClinicalTrials.gg
CompletedNCT00283491Updated Jan 21, 2009

The Effect of Lactobacillus Cultures on Iron Bioavailability.

An interventional study of Active Lactobacillus plantarum 299v and Inactive Lactobacillus plantarum 299v in Low Iron Stores, sponsored by University of Copenhagen. Completed at 1 site in Denmark. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-01-21.

Sponsored by University of Copenhagen · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

The purpose of this study is to determine the effect of a lactic acid fermented oat gruel on iron absorption in the upper and lower part of the intestine, respectively.

Read the detailed description

Iron deficiency and low iron stores are prevalent in infants, adolescents, and women of childbearing age in both Western and developing countries. One cause of iron deficiency is the low iron bioavailability from foods, which is partly due to inhibiting factors in the diet, such as phytate and phenolic compounds. A number of single meal studies with lactic acid fermented vegetables and cereals have shown a significant increase in iron absorption in humans. This is believed to be caused mainly by the lactic acid produced during the fermentation process, which conteracts the inhibiting effect of phytate.

A recent study of ours indicate that the increased nonheme iron absorption from a low iron bioavailability meal was due not only to an effect of the lactic acid produced, but also a specific effect of the lactic acid bacteria. As lactic acid bacteria colonizes the entire intestine but mainly the colon it is of interest to determine whether these bacteria can increase iron absorption from the distal part of the intestine since iron absorption normally is believed to be absorbed from the duodenum and most proximal small intestine.

The purpose of this study is therefore to determine the the effect of Lactobacillus plantarum 299v in a lactic acid fermented oat gruel on iron absorption in the proximal and distal small intestine, respectively, in a cross-over design with 18 healthy women of childbearing age, served both fermented oat gruel and pasteurized, fermented oat gruel.

02

Conditions studied

  • Low Iron Stores

Keywords

  • Iron absorption
  • Organic acids
  • Lactobacillus
  • Probiotic
03

In context

Lead sponsor

University of Copenhagen is the lead sponsor of 450 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • serum ferritin in the range 12-30 µg/L
  • hemoglobin > 110 g/L

Exclusion criteria

Exclusion Criteria:

  • pregnant or lactating
  • smoker
  • intake of vitamin-, mineral- or other dietary supplements during the study and 2 mo before start
  • sports practicing >10h/week
  • blood donation during the study and 2 mo before start
  • medication
  • participation in other isotope studies
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
18 participants (actual)

Study arms

  • Active comparator
    A

    Behavioral: Active Lactobacillus plantarum 299v

  • Placebo comparator
    B

    Dietary Supplement: Inactive Lactobacillus plantarum 299v

Interventions

  • BehavioralActive Lactobacillus plantarum 299v

    10\^11 cfu/meal in 2 meals on 2 consecutive days

  • Dietary supplementInactive Lactobacillus plantarum 299v

    Inactive form of the active treatment but with the fermentation products in the same concentration

06

What researchers measure

Primary outcomes

  1. Concentrations of 55-Fe and 59-Fe in blood 18 days after intake in first and second period, respectively (i.e. november and december 2005).

    Time frame: 2 mo

Secondary outcomes

  1. Measurement of serum-ferritin and transferrin receptor in the blood samples before and after each period.

    Time frame: 2 mo

07

Study locations

1 site
  • Department of Human Nutrition, The Royal Veterinary and Agricultural University
    Frederiksberg C, 1958, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 21, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00283491
Lead sponsor
University of Copenhagen
Collaborators
The Ministry of Science, Technology and Innovation, Denmark
First posted
Jan 30, 2006
Start date
Oct 2005
Completion
Nov 2005
Last update
Jan 21, 2009

Study contacts

Klaus Bukhave, MScD
study chair · Department of Human Nutrition, The Royal Veterinary and Agricultural University, Rolighedsvej 30, DK-1958 Frederiksberg C
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2005. You cannot join it, but the record below documents what was studied.

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