The Effect of Lactobacillus Cultures on Iron Bioavailability.

Low Iron Stores Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00283491
• Other study ID #: KF 01-219/03
• Secondary ID: IHE-KVL-M183
• Status: Completed
• Phase: N/A
• First received: January 27, 2006
• Last updated: January 20, 2009
• Start date: October 2005
• Est. completion date: November 2005

Study information

• Verified date: October 2005
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: November 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Low Iron Stores

Intervention

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

Locations

Country	Name	City	State
Denmark	Department of Human Nutrition, The Royal Veterinary and Agricultural University	Frederiksberg C

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	The Ministry of Science, Technology and Innovation, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		2 mo
Secondary	Measurement of serum-ferritin and transferrin receptor in the blood samples before and after each period.		2 mo