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Clinical Trials/NCT01433120
NCT01433120
Completed
Not Applicable

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

University of Copenhagen1 site in 1 country58 target enrollmentSeptember 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
University of Copenhagen
Enrollment
58
Locations
1
Primary Endpoint
Insulin resistance
Status
Completed
Last Updated
11 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
September 2011
End Date
August 2013
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Arne Astrup

MD, Professor

University of Copenhagen

Eligibility Criteria

Inclusion Criteria

  • Post-menopausal
  • BMI between 30-45 kg/m2
  • Waist circumference \> 80 cm
  • High leukocyte count

Exclusion Criteria

  • Medically-treated Type 2 diabetes or dyslipidaemia
  • Use of antibiotics during the last 3 months
  • Use of pro- or prebiotic supplements during the last 6 weeks
  • Illnesses related to the gastro-intestinal tract
  • History of psychiatric diseases (incl. depression)
  • Liver disease
  • Alcohol abuse

Outcomes

Primary Outcomes

Insulin resistance

Time Frame: Week 0,6

3H OGTT (75g glucose)

Changes in the gut microbiota

Time Frame: Week 0,6

Secondary Outcomes

  • Lipid metabolism(Week 0,6)
  • Inflammatory markers(Week 0,4,6)
  • Total fat mass and abdominal fat(Week 0,6)

Study Sites (1)

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