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The Effect of a Bifidobacterium and Polydextrose on Body Fat Mass

NCT01978691 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2016-02-02

No results posted yet for this study

Summary

Obesity is a major problem worldwide, and it is related to abnormalities in glucose and lipid metabolism. The purpose of this study is to investigate the effect of a dietary supplement containing probiotic (Bifidobacterium animalis ssp. lactis 420) and/or prebiotic (Litesse) on change in body fat mass in a double-blind, randomized, placebo-controlled intervention trial. The supplement is ingested once per day for the duration of six months, and participants will attend a follow-up visit one month after the end of the intervention. The study will enroll 232 participants (58 per study arm) in four research centers in southern Finland.

Conditions

Interventions

DIETARY_SUPPLEMENT

Bifidobacterium animalis ssp. lactis 420

Studied as a probiotic bacteria

DIETARY_SUPPLEMENT

Polydextrose

Studied as a prebiotic

OTHER

Placebo

Control

Sponsors & Collaborators

  • Danisco

    lead INDUSTRY

Principal Investigators

  • Aila Rissanen, MD · HYKS-instituutti Oy

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • Finland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01978691 on ClinicalTrials.gov