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The Effect of Lactobacillus Cultures on Iron Bioavailability.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00283491
First Posted: January 30, 2006
Last Update Posted: January 21, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
The Ministry of Science, Technology and Innovation, Denmark
Information provided by:
University of Copenhagen
  Purpose
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.

Condition Intervention
Low Iron Stores Behavioral: Active Lactobacillus plantarum 299v Dietary Supplement: Inactive Lactobacillus plantarum 299v

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: The Effect of a Lactic Acid Fermented Oat Gruel on Iron Absorption in the Proximal and Distal Small Intestine From a Phytate Rich Meal in Healthy Women of Childbearing Age.

Resource links provided by NLM:


Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Measurement of serum-ferritin and transferrin receptor in the blood samples before and after each period. [ Time Frame: 2 mo ]

Enrollment: 18
Study Start Date: October 2005
Study Completion Date: November 2005
Arms Assigned Interventions
Active Comparator: A Behavioral: Active Lactobacillus plantarum 299v
10^11 cfu/meal in 2 meals on 2 consecutive days
Placebo Comparator: B Dietary Supplement: Inactive Lactobacillus plantarum 299v
Inactive form of the active treatment but with the fermentation products in the same concentration

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.

  Eligibility

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00283491


Locations
Denmark
Department of Human Nutrition, The Royal Veterinary and Agricultural University
Frederiksberg C, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
The Ministry of Science, Technology and Innovation, Denmark
Investigators
Study Chair: Klaus Bukhave, MScD Department of Human Nutrition, The Royal Veterinary and Agricultural University, Rolighedsvej 30, DK-1958 Frederiksberg C
  More Information

ClinicalTrials.gov Identifier: NCT00283491     History of Changes
Other Study ID Numbers: KF 01-219/03
IHE-KVL-M183
First Submitted: January 27, 2006
First Posted: January 30, 2006
Last Update Posted: January 21, 2009
Last Verified: October 2005

Keywords provided by University of Copenhagen:
Iron absorption
Organic acids
Lactobacillus
Probiotic