Actively Recruiting
The Effects of Dietary Supplements on Glycemic Control, Body Composition and Hepatic Fat Content in People With Prediabetes
Led by Medical University of Vienna · Updated on 2024-05-31
50
Participants Needed
1
Research Sites
70 weeks
Total Duration
On this page
Sponsors
M
Medical University of Vienna
Lead Sponsor
B
BIOGENA GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Effects of Dietary Supplements on Glycemic Control, Body Composition and Hepatic Fat Content in People With Prediabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willingness and ability to provide written informed consent and follow all study requirements
- Age between 40 and 80 years
- Prediabetes with HbA1c level between 5.7% and 6.4%
- No prior antidiabetic treatment before joining the study
- Body mass index (BMI) between 25 and 35 kg/m2
- Fasting glucose between 100 and 125 mg/dl
- For women of childbearing potential, negative pregnancy test at inclusion and monthly until study end
You will not qualify if you...
- Unable or unwilling to provide written informed consent or comply with study requirements
- Age under 40 years
- HbA1c outside the range of 5.7% to 6.4%
- Significant liver or kidney function impairment
- Clinically significant abnormalities in medical history, lab tests, or physical exam
- Allergies to any components of the dietary supplements or placebos
- Diagnosed with type 1 diabetes, latent autoimmune diabetes in adults, maturity-onset diabetes of the young, or gestational diabetes
- Pregnant or breastfeeding
- Currently using any antidiabetic medication
- Using drugs or dietary supplements known to interact with study supplements
AI-Screening
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Trial Site Locations
Total: 1 location
1
Medical University of Vienna
Vienna, Austria, 1090
Actively Recruiting
Research Team
M
Michael Leutner
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
5
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