Effects of dietary supplements on blood sugar control and body health in prediabetes
The Effects of Dietary Supplements on Glycemic Control, Body Composition and Hepatic Fat Content in People With Prediabetes: a Randomized, Double-blind, Placebo-controlled Pilot Study
This study is testing whether three different dietary supplements can help people with prediabetes improve their blood sugar control and overall health over three months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | Medical University of Vienna Academic / other |
| Locations | 1 site (Vienna) |
| Trial ID | NCT06437938 on ClinicalTrials.gov |
What this trial studies
This clinical study investigates the impact of three dietary supplements on metabolic health, liver fat, and body composition in individuals diagnosed with prediabetes. Over a three-month period, participants will be assigned to receive either one of the dietary supplements or a placebo, with assessments including blood tests for glucose and lipid metabolism, liver function, and body composition analysis. Additionally, participants' psychological well-being, quality of life, and lifestyle habits will be evaluated through questionnaires. The study aims to provide insights into how these supplements may influence health outcomes in prediabetes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 40 to 80 years with prediabetes and a specific range of HbA1c levels.
Not a fit: Patients with type 1 diabetes or significant liver or kidney dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to effective dietary interventions for improving glycemic control and overall health in individuals with prediabetes.
How similar studies have performed: Previous studies have shown promising results with dietary supplements in managing metabolic parameters in prediabetes, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Vienna
- Medical University of Vienna — Vienna, Austria (Recruiting)
Study contacts
- Study coordinator: Michael Leutner
- Email: michael.leutner@meduniwien.ac.at
- Phone: 0140400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.