NCT01433120

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: University of Copenhagen · Academic / Other
• Sex: Female
• Age: 40 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Obesity
• Insulin Resistance

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lactobacillus paracasei ssp paracasei F19	10\^10 CFU of Lactobacillus paracasei F19 (dissolved in a glass of water once per day)
DIETARY_SUPPLEMENT	Flax seed fibres	10 grams of flax seed fibres per day (baked into two breakfast buns)
DIETARY_SUPPLEMENT	Maltodextrin (Placebo)	Maltodextrin is dissolved in a glas of water once per day

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-06-01
• Completion: 2013-08-01
• First posted: 2011-09-13
• Last updated: 2014-06-11

Locations

1 site across 1 country: Denmark