Obesity Clinical Trial
Official title:
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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