PreDiabetes
Conditions
Keywords
Prediabetes, Dietary supplements
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTDietary supplement A: Wasabi leaf powder (product of BIOGENA GmbH & Co KG)
To be taken according to the information in the study protocol/patient information leaflet.
DIETARY_SUPPLEMENTDietary supplement B: Berberin Phytoactive Gold (product of BIOGENA GmbH & Co KG)
To be taken according to the information in the study protocol/patient information leaflet.
DIETARY_SUPPLEMENTDietary 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.
OTHERPlacebo group 1: Placebo capsules corresponding to DiaPhyt® Formula 3.0/Berberin Phytoactive Gold
To be taken according to the information in the study protocol/patient information leaflet.
OTHERPlacebo group 2: Placebo powder corresponding to Wasabi leaf powder
To be taken according to the information in the study protocol/patient information leaflet.
Sponsors
BIOGENA GmbH
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* willingness and ability to provide written informed consent and comply with all study requirements, * age between 40 and 80 years * prediabetes with a HbA1c level between 5,7-6,4% * no antidiabetic treatment prior to the inclusion in the study * BMI between 25 and 35 kg/m2 * fasting glucose of 100-125mg/dl * in the case of women of childbearing potential, providing a negative pregnancy test at inclusion and once a month until the end of the study
Exclusion criteria
* failure to provide written informed consent and/or failure to comply with the study requirements * age \<40 years * HbA1c outside of the set range * significant impairments of hepatic and/or renal function * clinically significant abnormalities in medical history, routine laboratory screening, or in physical examination * allergies against any of the components of the dietary supplements or the placebo * type 1 diabetes mellitus, latent autoimmune diabetes in adults, maturity-onset diabetes of the young, gestational diabetes * pregnancy, lactation * concurrent treatment with any antidiabetic drug * concurrent treatment with drugs/dietary supplements that have proven interactions with dietary supplements included in our study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| changes in the time in range | 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 | time in range measured with continuous glucose monitoring system |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| changes in fasting glucose concentration | baseline, after 3 months | fasting glucose concentration |
| changes in fasting insulin concentration | baseline, after 3 months | fasting insulin concentration |
| changes in fasting c-peptide concentration | baseline, after 3 months | fasting c-peptide concentration |
| changes in HOMA-IR | baseline, after 3 months | 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 |
| changes in parameters of lipid metabolism | baseline, after 3 months | HDL, LDL, triglycerides, total cholesterol, apolipoprotein B, chylomicrons |
| changes in the hepatic fat content | baseline, after 3 months | hepatic fat content |
| changes in the hepatic fibrosis amount | baseline, after 3 months | hepatic fibrosis amount |
| changes in HbA1c values | baseline, after 3 months | HbA1c (glycated haemoglobin) values |
| changes in bilirubin concentrations | baseline, after 3 months | bilirubin |
| changes in the weight | baseline, after 3 months | weight |
| changes in the BMI | baseline, after 3 months | BMI calculated as weight in kilograms divided by the square of height in meters |
| changes in the anthropometric parameters | baseline, after 3 months | fat free mass, fat mass |
| changes in adipokine levels | baseline, after 3 months | adiponectin, leptin |
| changes in depressive, anxiety and stress-related symptoms | baseline, after 3 months | depressive, anxiety and stress-related symptoms assessed using the Depression-Anxiety-Stress Scale |
| changes in quality of life | baseline, after 3 months | quality of life assessed using the World Health Organization Quality of Life (WHOQOL-BREF) questionnaire |
| changes in parameters of hepatic function | baseline, after 3 months | GGT (gamma-glutamyltransferase), GOT (AST, aspartate transaminase), GPT (ALT, alanine transaminase), alkaline phosphatase |
Countries
Austria
Contacts
Primary ContactMichael Leutner
Outcome results
None listed