Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-25 @ 4:13 AM
NCT ID:
NCT01433120
Brief Summary:
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.
Study:
NCT01433120
Study Brief:
Protocol Section:
NCT01433120