NCT00283491

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2005

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 30, 2006

Completed
Last Updated

January 21, 2009

Status Verified

October 1, 2005

First QC Date

January 27, 2006

Last Update Submit

January 20, 2009

Conditions

Low Iron Stores

Keywords

Iron absorptionOrganic acidsLactobacillusProbiotic

Outcome Measures

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).

    2 mo

Secondary Outcomes (1)

  • Measurement of serum-ferritin and transferrin receptor in the blood samples before and after each period.

    2 mo

Study Arms (2)

A

ACTIVE COMPARATOR
Behavioral: Active Lactobacillus plantarum 299v

B

PLACEBO COMPARATOR
Dietary Supplement: Inactive Lactobacillus plantarum 299v

Interventions

Active Lactobacillus plantarum 299vBEHAVIORAL

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

A
Inactive Lactobacillus plantarum 299vDIETARY_SUPPLEMENT

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

B

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • serum ferritin in the range 12-30 µg/L
  • hemoglobin \> 110 g/L

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Human Nutrition, The Royal Veterinary and Agricultural University

Frederiksberg C, 1958, Denmark

Location

Study Officials

  • Klaus Bukhave, MScD

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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 27, 2006

First Posted

January 30, 2006

Study Start

October 1, 2005

Study Completion

November 1, 2005

Last Updated

January 21, 2009

Record last verified: 2005-10

Locations

DK(1)