The Effects of Dietary Supplements on Glycemic Control, Body Composition and Hepatic Fat Content in People With Prediabetes

Medical University of Vienna50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

PreDiabetes

Interventions

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

changes in the time in range

time in range measured with continuous glucose monitoring system

Time frame: 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