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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01433120
First Posted: September 13, 2011
Last Update Posted: June 11, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Lundbeck Foundation
Arla Foods
Information provided by (Responsible Party):
Arne Astrup, University of Copenhagen
  Purpose

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.


Condition Intervention
Obesity Insulin Resistance Dietary Supplement: Lactobacillus paracasei ssp paracasei F19 Dietary Supplement: Flax seed fibres Dietary Supplement: Maltodextrin (Placebo)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Targeting the Gut Microbiome to Investigate the Pathways of Progression From Obesity to Metabolic Diseases in an At-risk Population.

Resource links provided by NLM:


Further study details as provided by Arne Astrup, University of Copenhagen:

Primary Outcome Measures:
  • Insulin resistance [ Time Frame: Week 0,6 ]
    3H OGTT (75g glucose)

  • Changes in the gut microbiota [ Time Frame: Week 0,6 ]

Secondary Outcome Measures:
  • Inflammatory markers [ Time Frame: Week 0,4,6 ]
  • Lipid metabolism [ Time Frame: Week 0,6 ]
  • Total fat mass and abdominal fat [ Time Frame: Week 0,6 ]

Enrollment: 58
Study Start Date: September 2011
Study Completion Date: August 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Probiotic L. casei F19 Dietary Supplement: Lactobacillus paracasei ssp paracasei F19
10^10 CFU of Lactobacillus paracasei F19 (dissolved in a glass of water once per day)
Experimental: Flax seed fibres Dietary Supplement: Flax seed fibres
10 grams of flax seed fibres per day (baked into two breakfast buns)
Placebo Comparator: Placebo Dietary Supplement: Maltodextrin (Placebo)
Maltodextrin is dissolved in a glas of water once per day

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01433120


Locations
Denmark
Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen
Frederiksberg C, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
Lundbeck Foundation
Arla Foods
Investigators
Principal Investigator: Arne Astrup, MD, Professor Department of Human Nutrition, University of Copenhagen
  More Information

Additional Information:
Responsible Party: Arne Astrup, MD, Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01433120     History of Changes
Other Study ID Numbers: B-244 LuCamp
First Submitted: September 9, 2011
First Posted: September 13, 2011
Last Update Posted: June 11, 2014
Last Verified: June 2014

Keywords provided by Arne Astrup, University of Copenhagen:
Obesity
Insulin resistance
Microbiota
Probiotic
Prebiotic

Additional relevant MeSH terms:
Obesity
Insulin Resistance
Metabolic Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Hyperinsulinism
Glucose Metabolism Disorders