An interventional study of Dietary supplement A: Wasabi leaf powder (product of BIOGENA GmbH & Co KG) and Dietary supplement B: Berberin Phytoactive Gold (product of BIOGENA GmbH & Co KG) in PreDiabetes, sponsored by Medical University of Vienna. Recruiting at 1 site in Austria. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-05-31.
Sponsored by Medical University of Vienna · Not applicable, Interventional, and Supportive care
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.
999 studies on the registry are indexed under Prediabetic State; 238 are open to participants now.
This study's planned enrollment of 50 is below the median of 65 across 844 interventional studies indexed under Prediabetic State.
Browse Prediabetic State studies →Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.
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Exclusion Criteria:
Corresponding to dietary supplement groups B and C
Other: Placebo group 1: Placebo capsules corresponding to DiaPhyt® Formula 3.0/Berberin Phytoactive Gold
Corresponding to dietary supplement A
Other: Placebo group 2: Placebo powder corresponding to Wasabi leaf powder
Wasabi leaf powder
Dietary Supplement: Dietary supplement A: Wasabi leaf powder (product of BIOGENA GmbH & Co KG)
Berberin Phytoactive Gold
Dietary Supplement: Dietary supplement B: Berberin Phytoactive Gold (product of BIOGENA GmbH & Co KG)
DiaPhyt® Formula 3.0
Dietary Supplement: Dietary supplement C: DiaPhyt® Formula 3.0 (product of BIOGENA GmbH & Co KG)
To be taken according to the information in the study protocol/patient information leaflet.
To be taken according to the information in the study protocol/patient information leaflet.
To be taken according to the information in the study protocol/patient information leaflet.
To be taken according to the information in the study protocol/patient information leaflet.
To be taken according to the information in the study protocol/patient information leaflet.
changes in the time in range
time in range measured with continuous glucose monitoring system
Time frame: 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
changes in HbA1c values
HbA1c (glycated haemoglobin) values
Time frame: baseline, after 3 months
changes in fasting glucose concentration
fasting glucose concentration
Time frame: baseline, after 3 months
changes in fasting insulin concentration
fasting insulin concentration
Time frame: baseline, after 3 months
changes in fasting c-peptide concentration
fasting c-peptide concentration
Time frame: 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
Time frame: baseline, after 3 months
changes in parameters of lipid metabolism
HDL, LDL, triglycerides, total cholesterol, apolipoprotein B, chylomicrons
Time frame: baseline, after 3 months
changes in the hepatic fat content
hepatic fat content
Time frame: baseline, after 3 months
changes in the hepatic fibrosis amount
hepatic fibrosis amount
Time frame: baseline, after 3 months
changes in parameters of hepatic function
GGT (gamma-glutamyltransferase), GOT (AST, aspartate transaminase), GPT (ALT, alanine transaminase), alkaline phosphatase
Time frame: baseline, after 3 months
changes in bilirubin concentrations
bilirubin
Time frame: baseline, after 3 months
changes in the weight
weight
Time frame: baseline, after 3 months
changes in the BMI
BMI calculated as weight in kilograms divided by the square of height in meters
Time frame: baseline, after 3 months
changes in the anthropometric parameters
fat free mass, fat mass
Time frame: baseline, after 3 months
changes in adipokine levels
adiponectin, leptin
Time frame: 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
Time frame: baseline, after 3 months
changes in quality of life
quality of life assessed using the World Health Organization Quality of Life (WHOQOL-BREF) questionnaire
Time frame: baseline, after 3 months
Plan to share: No
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Medical University of Vienna