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Targeting the Gut Microbiome to Investigate the Pathways of Progression From Obesity to Metabolic Diseases in an At-risk Population.

NCT01433120 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2014-06-11

No results posted yet for this study

Summary

Studies of the human gut microbiome have suggested that treatment or prevention aimed at the obese microbiome could influence the development of obesity-associated metabolic disturbances.

The objective of this project is to explore if a dietary intervention in 60 obese women with the probiotic Lactobacillus paracasei ssp paracasei F19 or flax seed fibres targeting the gut microbiome, can reduce insulin resistance, low-grade inflammation or dyslipidaemia, and to explore the interaction between the human genome and the gut microbiome.

The study is based on the following hypotheses:

* Treatment with the probiotic Lactobacillus paracasei ssp paracasei F19 and flax seed fibres will lower the metabolic risk profile in the intervention groups compared with placebo.
* The effect on the metabolic risk markers can be correlated with changes in the gut microbiota (measured in faeces).

After completion of the dietary intervention, the participants are offered a 10-week weight reduction program. Those who participate in the weight-loss program are invited to an optional follow-up visit in connection with the last visit at the clinical dietician, for the purpose of exploring the effect of weight loss on the gut microbiota and obesity-associated metabolic disturbances.

Conditions

Interventions

DIETARY_SUPPLEMENT

Lactobacillus paracasei ssp paracasei F19

10\^10 CFU of Lactobacillus paracasei F19 (dissolved in a glass of water once per day)

DIETARY_SUPPLEMENT

Flax seed fibres

10 grams of flax seed fibres per day (baked into two breakfast buns)

DIETARY_SUPPLEMENT

Maltodextrin (Placebo)

Maltodextrin is dissolved in a glas of water once per day

Sponsors & Collaborators

  • Lundbeck Foundation

    collaborator OTHER

  • Arla Foods

    collaborator INDUSTRY

  • University of Copenhagen

    lead OTHER

Principal Investigators

  • Arne Astrup, MD, Professor · Department of Human Nutrition, University of Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-06-30
Completion
2013-08-31

Countries

  • Denmark

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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 NCT01433120 on ClinicalTrials.gov