Insulin Resistance, Obesity
Conditions
Keywords
Obesity, Insulin resistance, Microbiota, Probiotic, Prebiotic
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.
Interventions
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
Sponsors
Study design
Eligibility
Inclusion criteria
* Post-menopausal * BMI between 30-45 kg/m2 * Waist circumference \> 80 cm * High leukocyte count
Exclusion criteria
* Medically-treated Type 2 diabetes or dyslipidaemia * Use of antibiotics during the last 3 months * Use of pro- or prebiotic supplements during the last 6 weeks * Illnesses related to the gastro-intestinal tract * History of psychiatric diseases (incl. depression) * Liver disease * Alcohol abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insulin resistance | Week 0,6 | 3H OGTT (75g glucose) |
| Changes in the gut microbiota | Week 0,6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Inflammatory markers | Week 0,4,6 |
| Lipid metabolism | Week 0,6 |
| Total fat mass and abdominal fat | Week 0,6 |
Countries
Denmark