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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Lundbeck Foundation
Arla Foods
Information provided by (Responsible Party):
AAstrup, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01433120
First received: September 9, 2011
Last updated: June 29, 2012
Last verified: June 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 University of Copenhagen:

Primary Outcome Measures:
  • Insulin resistance [ Time Frame: Week 0,6 ] [ Designated as safety issue: No ]
    3H OGTT (75g glucose)

  • Changes in the gut microbiota [ Time Frame: Week 0,6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Inflammatory markers [ Time Frame: Week 0,4,6 ] [ Designated as safety issue: No ]
  • Lipid metabolism [ Time Frame: Week 0,6 ] [ Designated as safety issue: No ]
  • Total fat mass and abdominal fat [ Time Frame: Week 0,6 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2011
Estimated 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

Ages Eligible for Study:   40 Years to 70 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: AAstrup, MD, Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01433120     History of Changes
Other Study ID Numbers: B-244 LuCamp
Study First Received: September 9, 2011
Last Updated: June 29, 2012
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

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

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

ClinicalTrials.gov processed this record on April 17, 2014