Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen
Frederiksberg C, 1958, Denmark
NCT Number: NCT01433120
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.
Looking for future studies?
Notify Me40 year–70 year
Female
Interventional
Not applicable
Frederiksberg C, 1958, Denmark
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
10^10 CFU of Lactobacillus paracasei F19 (dissolved in a glass of water once per day)
10 grams of flax seed fibres per day (baked into two breakfast buns)
Maltodextrin is dissolved in a glas of water once per day
Time frame: Week 0,6
3H OGTT (75g glucose)
Time frame: Week 0,6
Time frame: Week 0,4,6
Time frame: Week 0,6
Time frame: Week 0,6
University of Copenhagen
Other
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