The Effects of Dietary Supplements on Glycemic Control, Body Composition and Hepatic Fat Content in People With Prediabetes
- Conditions
- PreDiabetes
- Registration Number
- NCT06437938
- Lead Sponsor
- Medical University of Vienna
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method changes in fasting glucose concentration baseline, after 3 months fasting glucose concentration
changes in adipokine levels baseline, after 3 months adiponectin, leptin
changes in parameters of lipid metabolism baseline, after 3 months HDL, LDL, triglycerides, total cholesterol, apolipoprotein B, chylomicrons
changes in HbA1c values baseline, after 3 months HbA1c (glycated haemoglobin) values
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 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 parameters of hepatic function baseline, after 3 months GGT (gamma-glutamyltransferase), GOT (AST, aspartate transaminase), GPT (ALT, alanine transaminase), alkaline phosphatase
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 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
Trial Locations
- Locations (1)
Medical University of Vienna
🇦🇹Vienna, Austria