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Obesity is associated with increased morbidity and mortality, but weight reduction is difficult to achieve. In this randomized controlled trial we will include 120 obese subjects. Subjects will be allocated to one of the 3 diet types (minus 500 kcal / d):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| yogurt diet | Experimental | yogurt-diet (-500 kcal/day, 500 g yogurt, high calcium) |
|
| dairy diet | Active Comparator | dairy diet: -500 kcal/day, high calcium, 500 g non-yogurt dairy products |
|
| standard diet | Active Comparator | standard diet: -500 kcal/day, low calcium, 500 g soya-yogurt |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| yogurt diet | Dietary Supplement | 500 g yogurt/day |
| |
| dairy diet |
| Measure | Description | Time Frame |
|---|---|---|
| fat mass | Changes in body fat mass assessed via dual-energy X-ray absorptiometry (DXA) (baseline vs. 12 weeks). | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | body weight [kg] | 12 weeks |
| BMI | BMI [kg/m²] | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elisabeth Lerchbaum, MD | Contact | 0043 316 385 12383 | elisabeth.lerchbaum@medunigraz.at |
| Name | Affiliation | Role |
|---|---|---|
| Elisabeth Lerchbaum, MD | Medical University of Graz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Graz, Department of Internal Medicine, Division of Endocrinology and Metabolism | Graz | 8036 | Austria |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Dietary Supplement |
500 g non-yogurt dairy products |
|
| standard diet | Dietary Supplement | 500 g soya-yogurt |
|
| waist circumference |
waist circumference [cm] |
| 12 weeks |
| hip circumference | hip circumference [cm] | 12 weeks |
| Systolic blood pressure | systolic blood pressure [mm Hg] | 12 weeks |
| Diastolic blood pressure | diastolic blood pressure [mm Hg] | 12 weeks |
| Body composition-lean mass | lean mass [kg] | 12 weeks |
| Body composition-total body fat | total body fat ([%] | 12 weeks |
| Body composition-gynoid fat mass | gynoid fat mass [kg] | 12 weeks |
| Body composition-android fat mass | android fat mass [kg] | 12 weeks |
| AUCglucose | Metabolic response during an oral glucose tolerance test (oGTT) as defined by AUCglucose | 12 weeks |
| AUCinsulin | Metabolic response during an oral glucose tolerance test (oGTT) as defined by AUCinsulin | 12 weeks |
| HOMA-IR | Insulin resistance assessed by homeostatic model assessment-insulin resistance (HOMA-IR) | 12 weeks |
| HOMA-beta | insulin sensitivity assessed by HOMA-beta | 12 weeks |
| MATSUDA | insulin sensitivity assessed by MATSUDA-index | 12 weeks |
| QUICKI | insulin sensitivity assessed by Quantitative Insulin-sensitivity Check Index (QUICKI) | 12 weeks |
| Total cholesterol | Total cholesterol [mg/dl] | 12 weeks |
| LDL cholesterol | LDL cholesterol [mg/dl] | 12 weeks |
| HDL cholesterol | HDL cholesterol [mg/dl] | 12 weeks |
| Triglycerides | Triglycerides [mg/dl] | 12 weeks |
| HbA1c | HbA1c [mmol/mol] | 12 weeks |
| Total testosterone | Total testosterone [nmol/l] | 12 weeks |
| Free testosterone | Free testosterone [nmol/l] | 12 weeks |
| Free androgen index | FAI (Free androgen index) | 12 weeks |
| androstenedione | androstenedione [nmol/l] | 12 weeks |
| DHEAS | dehydroepiandrosterone sulfate (DHEAS) [µmol/L] | 12 weeks |
| stool microbiome | Composition of the stool microbiome Microbiome analysis will be performed through the following steps: patient collection and provision of a stool specimen, DNA isolation from the specimen, PCR reaction to amplify the selected region of the 16S rRNA gene (only present in bacteria), sequencing of the amplicons using next-generation sequencing technology, bioinformatics processing and analysis of the data using suitable software. | 12 weeks |
| Satiety | assessed via visual analogue scale [VAS]: "Satiety", minimum score 0, maximum score 10, higher scores mean a worse outcome. | 12 weeks |
| Food craving | assessed via visual analogue scale [VAS]: "Food craving", minimum score 0, maximum score 10, higher scores mean a worse outcome. | 12 weeks |
| Quality of life during weight reduction | Quality of life assessed via visual analogue scale [VAS]: "How is your quality of life during weight reduction?", minimum score 0, maximum score 10, higher scores mean a better outcome. | 12 weeks |
| Compliance | assessed via visual analogue scale [VAS]: "Compliance", minimum score 0, maximum score 10, higher scores mean a better outcome. | 12 weeks |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |