Effect of Nutritional Interventions on Inflammatory Status in Healthy Overweight Men

NCT00655798 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2008-04-10

No results posted yet for this study

Summary

In the present study it is hypothesized that a reduction of the inflammatory status may prevent the occurrence of disorders and diseases related to overweight.

In this study the effects of nutritional compounds will be studied in overweight men with a low grade inflammatory status. We will investigate the effects of 3 different food treatments as compared to a placebo on markers of inflammation and on parameters of glucose and fat metabolism. The three different food treatments are a food mix and two yogurts each containing different probiotic strains. The food mix is composed of a mix of nutritional components, each reported to affect inflammation parameters and (or) anti-oxidant status but different in their -hypothesized-mode of action.

Conditions

Interventions

DIETARY_SUPPLEMENT

Placebo

plain yogurt and capsules containing cellulose

DIETARY_SUPPLEMENT

Plain Yogurt + mix of anti-oxidants capsules

plain yogurt and capsules containing mix of anti-oxidants

DIETARY_SUPPLEMENT

Yogurt containing Lactobacillus helveticus

Yogurt containing the probiotic Lactobacillus helveticus

DIETARY_SUPPLEMENT

Yogurt containing Bifidobacterium animalis ssp.

Yogurt containing the probiotic Bifidobacterium animalis ssp.

Sponsors & Collaborators

  • Chr Hansen

    collaborator INDUSTRY
  • TNO

    lead OTHER

Principal Investigators

  • Gertruud Bakker, PhD · TNO Quality of Life, Zeist, The Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2007-05-31
Completion
2007-06-30

Countries

  • Netherlands

Study Locations

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Entities

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 NCT00655798 on ClinicalTrials.gov