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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06437938
Other study ID # 1543/2023
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 25, 2024
Est. completion date August 31, 2025

Study information

Verified date May 2024
Source Medical University of Vienna
Contact Michael Leutner
Phone 0140400
Email michael.leutner@meduniwien.ac.at
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date August 31, 2025
Est. primary completion date May 1, 2025
Accepts healthy volunteers No
Gender All
Age group 40 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Dietary 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 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 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.
Other:
Placebo 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.
Placebo group 2: Placebo powder corresponding to Wasabi leaf powder
To be taken according to the information in the study protocol/patient information leaflet.

Locations

Country Name City State
Austria Medical University of Vienna Vienna

Sponsors (2)

Lead Sponsor Collaborator
Medical University of Vienna BIOGENA GmbH

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary changes in HbA1c values HbA1c (glycated haemoglobin) values baseline, after 3 months
Secondary changes in fasting glucose concentration fasting glucose concentration baseline, after 3 months
Secondary changes in fasting insulin concentration fasting insulin concentration baseline, after 3 months
Secondary changes in fasting c-peptide concentration fasting c-peptide concentration baseline, after 3 months
Secondary 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
Secondary changes in parameters of lipid metabolism HDL, LDL, triglycerides, total cholesterol, apolipoprotein B, chylomicrons baseline, after 3 months
Secondary changes in the hepatic fat content hepatic fat content baseline, after 3 months
Secondary changes in the hepatic fibrosis amount hepatic fibrosis amount baseline, after 3 months
Secondary changes in parameters of hepatic function GGT (gamma-glutamyltransferase), GOT (AST, aspartate transaminase), GPT (ALT, alanine transaminase), alkaline phosphatase baseline, after 3 months
Secondary changes in bilirubin concentrations bilirubin baseline, after 3 months
Secondary changes in the weight weight baseline, after 3 months
Secondary changes in the BMI BMI calculated as weight in kilograms divided by the square of height in meters baseline, after 3 months
Secondary changes in the anthropometric parameters fat free mass, fat mass baseline, after 3 months
Secondary changes in adipokine levels adiponectin, leptin baseline, after 3 months
Secondary 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
Secondary changes in quality of life quality of life assessed using the World Health Organization Quality of Life (WHOQOL-BREF) questionnaire baseline, after 3 months
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