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