Food4GutMarKIT - Evaluation of a Tailored Personalized Food Concept for a Healthy Gut Microbiota and Validation of Biomarkers for Monitoring of Its Effects

Study Overview
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Brief Summary
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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.

Official Title
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Food4GutMarKIT - Evaluation of a Tailored Personalized Food Concept for a Healthy Gut Microbiota and Validation of Biomarkers for Monitoring of Its Effects

Conditions
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Healthy, Overweight, Obese

Intervention / Treatment
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* Other: Diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women Age 18 - 70 years BMI 18,5-25 for normal weighed and BMI 25-39 for overweighed/obese Hb ≥ 120g/L Serum TSH <4,0 mIU/L Signed informed consent 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: LDL ≥ 3,0 mmol/L HDL ≤1.04 mmol/L Total cholesterol ≥ 5.0 mmol/L Triglycerider ≥1.69 mmol/L Blood pressure ≥130/85 mmHg Fasting glucose ≥6.1 mmol/L. Exclusion Criteria: Blood donation or participation in a clinical study with blood sampling within 30 days prior to screening visit and throughout the study. Following any weight reduction program or having followed one during the last 6 months Food allergies or intolerances Vegetarian or other diet restrictions (due to the standardized meal plan) History of stomach or gastrointestinal conditions (Inflammatory bowel disease, Crohn's disease, malabsorption, colostomy, bowel resection, gastric bypass surgery etc.) Previous major gastrointestinal surgery Pregnant or lactating or wish to become pregnant during the period of the study. Unable to understand written and spoken Swedish Lack of suitability for participation in the trial, for any reason, as judged by the medical doctor or PI. Pharmacological medication with drugs known to affect the microbiota, e.g. antibiotics, within 6 months prior to baseline. Intake of probiotics within 6 months prior to baseline. Have type I diabetes Receiving pharmacological treatment for type II diabetes (treatments based on life style interventions are acceptable, as long as it is compatible with the study protocol) Using nicotine products on a daily basis (including chewing gum, patches, snus etc.) History of heart failure or heart attack (TIA) within 1 year prior to screening Thyroid disorder

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Diet<br>Average Swedish diet | Other: Diet<br>* 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<br>|
| Experimental: Intervention Diet<br>The intervention diet will be based on food items that have shown a beneficial effect on gut microbiota associated with cardiometabolic risk factors. | Other: Diet<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |