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| Name | Class |
|---|---|
| Lundbeck Foundation | OTHER |
| Arla Foods | INDUSTRY |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic L. casei F19 | Experimental |
| |
| Flax seed fibres | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus paracasei ssp paracasei F19 | Dietary Supplement | 10^10 CFU of Lactobacillus paracasei F19 (dissolved in a glass of water once per day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Insulin resistance | 3H OGTT (75g glucose) | Week 0,6 |
| Changes in the gut microbiota | Week 0,6 |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory markers | Week 0,4,6 | |
| Lipid metabolism | Week 0,6 | |
| Total fat mass and abdominal fat |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arne Astrup, MD, Professor | Department of Human Nutrition, University of Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen | Frederiksberg C | 1958 | Denmark |
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| Label | URL |
|---|---|
| Related Info | View source |
| Related Info | View source |
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| Flax seed fibres | Dietary Supplement | 10 grams of flax seed fibres per day (baked into two breakfast buns) |
|
| Maltodextrin (Placebo) | Dietary Supplement | Maltodextrin is dissolved in a glas of water once per day |
|
| Week 0,6 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C008315 | maltodextrin |
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