Clinical trial NCT00283491: The Effect of Lactobacillus Cultures on Iron Bioavailability.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Iron Stores
Keywords: Iron absorption
Organic acids
Lactobacillus
Probiotic
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: The Ministry of Science, Technology and Innovation, Denmark
First posted: 2006-01-30
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: 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).
timeFrame: 2 mo
Secondary outcomes:
measure: Measurement of serum-ferritin and transferrin receptor in the blood samples before and after each period.
timeFrame: 2 mo
Other outcomes:
Locations:
city: Frederiksberg C
country: Denmark
facility: Department of Human Nutrition, The Royal Veterinary and Agricultural University
Study officials:
affiliation: Department of Human Nutrition, The Royal Veterinary and Agricultural University, Rolighedsvej 30, DK-1958 Frederiksberg C
name: Klaus Bukhave, MScD
role: STUDY_CHAIR
References: