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

Study Overview
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Brief Summary
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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.

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

Conditions
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Obesity, Insulin Resistance

Intervention / Treatment
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* Dietary Supplement: Lactobacillus paracasei ssp paracasei F19
* Dietary Supplement: Flax seed fibres
* Dietary Supplement: Maltodextrin (Placebo)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic L. casei F19<br> | Dietary Supplement: Lactobacillus paracasei ssp paracasei F19<br>* 10^10 CFU of Lactobacillus paracasei F19 (dissolved in a glass of water once per day)<br>|
| Experimental: Flax seed fibres<br> | Dietary Supplement: Flax seed fibres<br>* 10 grams of flax seed fibres per day (baked into two breakfast buns)<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Maltodextrin (Placebo)<br>* Maltodextrin is dissolved in a glas of water once per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin resistance | 3H OGTT (75g glucose) | Week 0,6 | 
| Changes in the gut microbiota |  | Week 0,6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory markers |  | Week 0,4,6 | 
| Lipid metabolism |  | Week 0,6 | 
| Total fat mass and abdominal fat |  | Week 0,6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotic, Obesity, Insulin resistance, Microbiota, Prebiotic