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

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ClinicalTrials.gov Identifier: NCT01433120
Recruitment Status : Completed
First Posted : September 13, 2011
Last Update Posted : June 11, 2014
Sponsor:
Collaborators:
Lundbeck Foundation
Arla Foods
Information provided by (Responsible Party):
Arne Astrup, University of Copenhagen

September 9, 2011
September 13, 2011
June 11, 2014
September 2011
June 2012   (Final data collection date for primary outcome measure)
  • Insulin resistance [ Time Frame: Week 0,6 ]
    3H OGTT (75g glucose)
  • Changes in the gut microbiota [ Time Frame: Week 0,6 ]
Same as current
Complete list of historical versions of study NCT01433120 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Targeting the Gut Microbiome to Investigate the Pathways of Progression From Obesity to Metabolic Diseases in an At-risk Population.
Targeting the Gut Microbiome to Investigate the Pathways of Progression From Obesity to Metabolic Diseases in an At-risk Population.

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.

Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
  • Obesity
  • Insulin Resistance
  • 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
  • Experimental: Probiotic L. casei F19
    Intervention: Dietary Supplement: Lactobacillus paracasei ssp paracasei F19
  • Experimental: Flax seed fibres
    Intervention: Dietary Supplement: Flax seed fibres
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Maltodextrin (Placebo)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
60
August 2013
June 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
40 Years to 70 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT01433120
B-244 LuCamp
No
Not Provided
Not Provided
Arne Astrup, University of Copenhagen
University of Copenhagen
  • Lundbeck Foundation
  • Arla Foods
Principal Investigator: Arne Astrup, MD, Professor Department of Human Nutrition, University of Copenhagen
University of Copenhagen
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP