Fermented Dairy Products and The Metabolic Syndrome

Study Overview
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Brief Summary
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The study will be conducted as a randomized controlled trial with four parallel arms including four dairy products. We will investigate the health effects of including yogurt in the diet through a 16-weeks intervention period among 100 volunteering males with symptoms of the metabolic syndrome. The study has a total duration of 20 weeks as a wash out period of four weeks will be initiated prior to the intervention.

Official Title
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Matrix Characterization and Effects of Fermented Dairy Products on Liver Fat, Cardiometabolic Risk and Gut Microbiome in Males With Symptoms of Metabolic Syndrome

Conditions
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Overweight or Obesity, Metabolic Syndrome

Intervention / Treatment
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* Dietary Supplement: Regular whole milk
* Dietary Supplement: Yogurt with live bacteria
* Dietary Supplement: Yogurt with inactivated bacteria
* Dietary Supplement: Acidified whole milk


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male Age between 30-70 years BMI of 28-45 kg/m2 Abdominal obesity (defined as waist circumference >102 cm) Provided voluntary written informed consent Exclusion Criteria: Body weight changes +/- 5% in the past three months Any diet, allergy or intolerance which results in not being able to follow the study protocol Contraindications related to MRI (pacemaker, stent, magnitic metal in the body, claustrophobia, physiological diseases or a body weight >160 kg) History or diagnosis of diabetes History or diagnosis of heart, liver, gastrointestinal or kidney disease History or diagnosis of illness related to energy balance History or diagnosis of eating disorders Simultaneous blood donation for other purpose than this study (and one month before initiating the study) Simultaneous participation in other clinical intervention studies Any other condition that judged by the investgator may interfere with the adherence to the study protocol

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

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
Interventional Model Description: 16-week parallel randomized controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Regular whole milk<br>Substitution of a part of the habitual diet with 400 g/day of regular whole milk | Dietary Supplement: Regular whole milk<br>* 400 g/day of regular whole milk<br>* Other names: Milk;|
| Experimental: Yogurt with live bacteria<br>Substitution of a part of the habitual diet with 400 g/day of yogurt with life bacteria | Dietary Supplement: Yogurt with live bacteria<br>* 400 g/day of yogurt with live bacteria<br>* Other names: Yogurt;|
| Experimental: Yogurt with inactivated bacteria<br>Substitution of a part of the habitual diet with 400 g/day of yogurt with inactivated bacteria | Dietary Supplement: Yogurt with inactivated bacteria<br>* 400 g/day of yogurt with inactivated bacteria<br>* Other names: Yogurt;|
| Experimental: Acidified whole milk<br>Substitution of a part of the habitual diet with 400 g/day of acidified whole milk | Dietary Supplement: Acidified whole milk<br>* 400 g/day of yogurt with acidified whole milk<br>* Other names: Dairy product;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver fat | Measurements of liver fat by Magnetic Resonance Imaging | Change from Week 0 to week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiometabolic risk | Measured by fasting cholesterol, HDL, LDL, Triglycerid and LDL fractions | Change from Week 0 to week 16 | 
| Cardiometabolic risk | Measured by fasting ALAT | Change from Week 0 to week 16 | 
| Cardiometabolic risk | Measured by fasting blood pressure (automatic device) | Change from Week 0 to week 16 | 
| Gut microbiome | Measurments of microbiota (fecal spot samples) | Change from week -4 to week 16 | 
| Glucose metabolism (fasting samples) | Measurements of fasting glucose, insulin, C-peptide, HbA1C | Change from Week 0 to week 16 | 
| Glucose metabolism (5 hour oral glucose tolerance test) | Measurements of glucose, insulin and C-peptide during a 5 hour oral glucose tolerance test | Week 16 (5 hour test) | 
| Inflammation | Measurements of fasting CRP | Change from Week 0 to week 16 | 
| Inflammation | Measurements of fasting IL-6 | Change from Week 0 to week 16 | 
| Inflammation | Measurements of fasting TNF-alfa | Change from Week 0 to week 16 | 
| Body composition | Measurements of body weight (every week), height (stadiometer) (only at screening), waist and hip circumference (non-elastic tape), sagittal diameter (abdominal caliper) (only week 0 and 16) as wells as fat mass and fat free mass (whole body DXA scan) (only week 0 and 16). | Change from week -4 to week 16 | 
| Fat disposition and pancreatic fat | Measurements of viceral, subcutaneous and pancreatic fat by Magnetic Resonance Imaging | Change from Week 0 to week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dairy, Liver fat, Glucose metabolism