CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 57 enrolled
Drug / intervention
lactose +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00599859
NCT00599859N/ACompleted

Differential Biologic Impact of Lactose Consumption in Lactase Persistent and Non-persistent Populations: Evaluation of Microflora and Insulin/Glycemic Response

Sir Mortimer B. Davis - Jewish General Hospital·interventional·Posted Jan 24, 2008·Updated Sep 21, 2009

In Brief

A clinical study evaluating lactose for Lactose Intolerance. Completed, enrolled 57 participants across 1 site.

Detailed Summary

The genetics of lactase divides the population into 2 phenotypes: Those who can(LP) and those who cannot(LNP)digest lactose. This division may help modify disease risks according to geographic population distribution. At least some of the putative mechanism of risk modification may relate to an effect of undigested lactose on lower intestinal bacteria. The effect may provide for support of beneficial microbes. The amount of lactose reaching the colon is made easier in LNP than LP subjects who have to consume larger amounts to have meaningful spillover into the lower bowel.The current study examines whether there are quantifiable qualitative fecal bacterial differences to a standard intake of lactose(milk sugar)between these 2 different phenotypic populations. Finding of differences would lend support to the notion that for some diseases LP and LNP subjects face different risks even in an area of uniform disease risk if they consume lactose (found in dairy foods). The primary end point is comparison of 4 groups of specific bacteria between LP and LNP participants before and after 2 weeks of lactose(in powder form mixed in water) consumption. Classification is based on genetic analysis and secondarily on breath hydrogen results. Results are compared within groups. The secondary outcome is comparison of 4 groups of bacteria between LP and LNP subjects against each group of stool samples obtained on the first visit. Results are obtained between groups. Additional information and other secondary outcomes are to evaluate any relationship between diet intake and the 4 groups of bacteria on the first visit Another outcome will be to compare within groups any effect of lactose consumption on insulin and glucose levels within the 2 groups.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 24, 2008
Enrollment StartSep 1, 2006
Primary CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 18.4 years ago

Interventions

lactosedietary

consumption of 50g lactose/day in 2 divided doses mixed in water.

lactosedietary

consumption of lactose 50g/day in 2 divided doses mixed in water