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The Effect of Lactobacillus Cultures on Iron Bioavailability.

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.
 
ClinicalTrials.gov Identifier: NCT00283491
Recruitment Status : Completed
First Posted : January 30, 2006
Last Update Posted : January 21, 2009
Sponsor:
Collaborator:
The Ministry of Science, Technology and Innovation, Denmark
Information provided by:
University of Copenhagen

Tracking Information
First Submitted Date  ICMJE January 27, 2006
First Posted Date  ICMJE January 30, 2006
Last Update Posted Date January 21, 2009
Study Start Date  ICMJE October 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2007)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 27, 2006)
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).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2007)
Measurement of serum-ferritin and transferrin receptor in the blood samples before and after each period. [ Time Frame: 2 mo ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2006)
Measurement of serum-ferritin and transferrin receptor in the blood samples before and after each period.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Lactobacillus Cultures on Iron Bioavailability.
Official Title  ICMJE 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.
Brief 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Low Iron Stores
Intervention  ICMJE
  • Behavioral: Active Lactobacillus plantarum 299v
    10^11 cfu/meal in 2 meals on 2 consecutive days
  • Dietary Supplement: Inactive Lactobacillus plantarum 299v
    Inactive form of the active treatment but with the fermentation products in the same concentration
Study Arms  ICMJE
  • Active Comparator: A
    Intervention: Behavioral: Active Lactobacillus plantarum 299v
  • Placebo Comparator: B
    Intervention: Dietary Supplement: Inactive Lactobacillus plantarum 299v
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 27, 2006)
18
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00283491
Other Study ID Numbers  ICMJE KF 01-219/03
IHE-KVL-M183
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University of Copenhagen
Collaborators  ICMJE The Ministry of Science, Technology and Innovation, Denmark
Investigators  ICMJE
Study Chair: Klaus Bukhave, MScD Department of Human Nutrition, The Royal Veterinary and Agricultural University, Rolighedsvej 30, DK-1958 Frederiksberg C
PRS Account University of Copenhagen
Verification Date October 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP