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
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 or disease||Intervention/treatment||Phase|
|Obesity Insulin Resistance||Dietary Supplement: Lactobacillus paracasei ssp paracasei F19 Dietary Supplement: Flax seed fibres Dietary Supplement: Maltodextrin (Placebo)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||58 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Targeting the Gut Microbiome to Investigate the Pathways of Progression From Obesity to Metabolic Diseases in an At-risk Population.|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||August 2013|
|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
- Insulin resistance [ Time Frame: Week 0,6 ]3H OGTT (75g glucose)
- Changes in the gut microbiota [ Time Frame: Week 0,6 ]
- 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 ]
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
|Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen|
|Frederiksberg C, Denmark, 1958|
|Principal Investigator:||Arne Astrup, MD, Professor||Department of Human Nutrition, University of Copenhagen|