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Completed

NCT Number: NCT00283491

The Effect of Lactobacillus Cultures on Iron Bioavailability.

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.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Human Nutrition, The Royal Veterinary and Agricultural University

Frederiksberg C, 1958, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active Lactobacillus plantarum 299v

Behavioral

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

Inactive Lactobacillus plantarum 299v

Dietary Supplement

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

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

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • The Ministry of Science, Technology and Innovation, Denmark

Registry information

Official study 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.

Important dates

Study start
2005
Study completion
2005
First posted
Jan 30, 2006
Registry last updated
Jan 21, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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