The Effect of Lactobacillus Cultures on Iron Bioavailability.

NCT ID: NCT00283491

Last Updated: 2009-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2005-11-30

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.

Conditions

Low Iron Stores

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

A

Group Type: ACTIVE_COMPARATOR

Active Lactobacillus plantarum 299v

Intervention Type: BEHAVIORAL

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

B

Group Type: PLACEBO_COMPARATOR

Inactive Lactobacillus plantarum 299v

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Active Lactobacillus plantarum 299v

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

Intervention Type: BEHAVIORAL

Inactive Lactobacillus plantarum 299v

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

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

The Ministry of Science, Technology and Innovation, Denmark

OTHER_GOV

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: lead

Principal Investigators

Klaus Bukhave, MScD

Role: STUDY_CHAIR

Department of Human Nutrition, The Royal Veterinary and Agricultural University, Rolighedsvej 30, DK-1958 Frederiksberg C

Locations

Department of Human Nutrition, The Royal Veterinary and Agricultural University

Frederiksberg C, , Denmark

Countries

Denmark

Other Identifiers

IHE-KVL-M183

Identifier Type: -

Identifier Source: secondary_id

KF 01-219/03

Identifier Type: -

Identifier Source: org_study_id