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The overall aim in this "proof-of-concept" study is to evaluate if a diet concept, based on foods that have individually been reported to beneficially affect gut microbiota in fact has an effect on gut microbiota composition and activity among healthy and obese subjects and whether the effects are associated with altered cardiometabolic risk factors. The aim is further to investigate if such alterations are reflected in changes of the fecal and plasma metabolome. In total, 40 men and women, who meet all the inclusion criteria and none of the exclusion criteria will be invited to participate in the study. The participants will follow an intervention diet for 6 weeks and a control diet for 6 weeks, with a 6-week wash-out period in between and will be randomized to either begin with the intervention diet or the control diet.
The study will be running over 18 weeks (including a 6-week wash-out period) and it will include 9 visits at the clinic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Diet | Active Comparator | Average Swedish diet |
|
| Intervention Diet | Experimental | The intervention diet will be based on food items that have shown a beneficial effect on gut microbiota associated with cardiometabolic risk factors. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet | Other | A review has been undertaken to both identify specific bacteria associated with cardiometabolic risk factors and food items that have been shown to affect such bacteria in a beneficial direction. The intervention diet will include a variety of food items e.g. vegetables, fermented vegetables, fermented dairy products and cereal products. The control diet is based on a Swedish Average Diet |
| Measure | Description | Time Frame |
|---|---|---|
| Gut microbiome | Fecal samples will analyzed for composition of the gut microbiome. Difference in gut microbiota OTUs between the two diets. Baseline compared with after 6 weeks of intervention or control. | 6 weeks |
| Gut microbiome | Fecal samples will analyzed for composition of the gut microbiome. Change in gut microbiota OTUs between baseline and 6 and 18 weeks of intervention or control. | 6 weeks, 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Triglycerides | Investigate if fasting plasma triglycerides differ between control and intervention. | 3 weeks, 6 weeks, 12 weeks and 18 weeks |
| Cholesterol | Investigate if fasting plasma cholesterol differ between control and intervention. |
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Inclusion Criteria:
Among the overweighed, they need to have waist circumference > 102 cm/88 cm for men and women respectively. All overweighed participants must have one of the following risk factors for cardiovascular decease, whereas the normal weighed could have or not elevated risk factors:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rikard Landberg, Dr | Chalmers University of Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Gothenburg, Department of Food and Nutrition and Sport Science | Gothenburg | Sweden |
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|
| 3 weeks, 6 weeks, 12 weeks and 18 weeks |
| Low-density lipid protein | Investigate if fasting plasma Low-density lipid proteindiffer between control and intervention. | 3 weeks, 6 weeks, 12 weeks and 18 weeks |
| High-density lipid protein | Investigate if fasting plasma High-density lipid protein differ between control and intervention. | 3 weeks, 6 weeks, 12 weeks and 18 weeks |
| Blood pressure | Investigate if fasting blood pressure differ between control and intervention. | 3 weeks, 6 weeks, 12 weeks and 18 weeks |
| Fasting glucose | Investigate if fasting plasma glucose differ between control and intervention. | 3 weeks, 6 weeks, 12 weeks and 18 weeks |
| C-reactive protein | Investigate if fasting plasma C-reactive protein differ between control and intervention. | 3 weeks, 6 weeks, 12 weeks and 18 weeks |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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