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| Name | Class |
|---|---|
| BIOGENA GmbH | UNKNOWN |
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This clinical study aims to explore the effects of 3 dietary supplements on metabolic parameters, liver fat content, and body composition in individuals with prediabetes. Prediabetes refers to a condition where blood sugar levels are higher than normal but not high enough for a diabetes diagnosis. The study will last for three months, during which participants will either take a dietary supplement or a placebo. Five groups will be studied, including placebo groups. Blood tests will assess glucose and lipid metabolism parameters, adipokines, and liver and kidney function. Liver stiffness and fat content will also be measured using elastography. Additionally, body composition will be assessed, and participants' psychological state, quality of life, eating habits and sports habits will be evaluated using questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo group 1 | Placebo Comparator | Corresponding to dietary supplement groups B and C |
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| Placebo group 2 | Placebo Comparator | Corresponding to dietary supplement A |
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| Dietary supplement group A | Experimental | Wasabi leaf powder |
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| Dietary supplement group B | Placebo Comparator | Berberin Phytoactive Gold |
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| Dietary supplement group C | Placebo Comparator | DiaPhyt® Formula 3.0 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary supplement A: Wasabi leaf powder (product of BIOGENA GmbH & Co KG) | Dietary Supplement | To be taken according to the information in the study protocol/patient information leaflet. |
| Measure | Description | Time Frame |
|---|---|---|
| changes in the time in range | time in range measured with continuous glucose monitoring system | 2 weeks at baseline before start of the dietary supplement, 2 weeks during the last 2 weeks of the 3 month dietary supplement ingestion phase |
| Measure | Description | Time Frame |
|---|---|---|
| changes in HbA1c values | HbA1c (glycated haemoglobin) values | baseline, after 3 months |
| changes in fasting glucose concentration | fasting glucose concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Leutner | Contact | 0140400 | 20690 | michael.leutner@meduniwien.ac.at |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Recruiting | Vienna | 1090 | Austria |
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| Dietary supplement B: Berberin Phytoactive Gold (product of BIOGENA GmbH & Co KG) | Dietary Supplement | To be taken according to the information in the study protocol/patient information leaflet. |
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| Dietary supplement C: DiaPhyt® Formula 3.0 (product of BIOGENA GmbH & Co KG) | Dietary Supplement | To be taken according to the information in the study protocol/patient information leaflet. |
|
| Placebo group 1: Placebo capsules corresponding to DiaPhyt® Formula 3.0/Berberin Phytoactive Gold | Other | To be taken according to the information in the study protocol/patient information leaflet. |
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| Placebo group 2: Placebo powder corresponding to Wasabi leaf powder | Other | To be taken according to the information in the study protocol/patient information leaflet. |
|
| baseline, after 3 months |
| changes in fasting insulin concentration | fasting insulin concentration | baseline, after 3 months |
| changes in fasting c-peptide concentration | fasting c-peptide concentration | baseline, after 3 months |
| changes in HOMA-IR | HOMA-IR calculated as fasting insulin level (micro-units per milliliter) multiplied by the fasting blood glucose level (milligrams per deciliter), dividing the result by 405 | baseline, after 3 months |
| changes in parameters of lipid metabolism | HDL, LDL, triglycerides, total cholesterol, apolipoprotein B, chylomicrons | baseline, after 3 months |
| changes in the hepatic fat content | hepatic fat content | baseline, after 3 months |
| changes in the hepatic fibrosis amount | hepatic fibrosis amount | baseline, after 3 months |
| changes in parameters of hepatic function | GGT (gamma-glutamyltransferase), GOT (AST, aspartate transaminase), GPT (ALT, alanine transaminase), alkaline phosphatase | baseline, after 3 months |
| changes in bilirubin concentrations | bilirubin | baseline, after 3 months |
| changes in the weight | weight | baseline, after 3 months |
| changes in the BMI | BMI calculated as weight in kilograms divided by the square of height in meters | baseline, after 3 months |
| changes in the anthropometric parameters | fat free mass, fat mass | baseline, after 3 months |
| changes in adipokine levels | adiponectin, leptin | baseline, after 3 months |
| changes in depressive, anxiety and stress-related symptoms | depressive, anxiety and stress-related symptoms assessed using the Depression-Anxiety-Stress Scale | baseline, after 3 months |
| changes in quality of life | quality of life assessed using the World Health Organization Quality of Life (WHOQOL-BREF) questionnaire | baseline, after 3 months |
| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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