Clinical trial NCT06437938: The Effects of Dietary Supplements on Glycemic Control, Body Composition and Hepatic Fat Content in People With Prediabetes
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: PreDiabetes
Keywords: Prediabetes
Dietary supplements
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: BIOGENA GmbH
First posted: 2024-05-31
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: changes in the time in range
timeFrame: 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 outcomes:
measure: changes in HbA1c values
timeFrame: baseline, after 3 months
measure: changes in fasting glucose concentration
timeFrame: baseline, after 3 months
measure: changes in fasting insulin concentration
timeFrame: baseline, after 3 months
measure: changes in fasting c-peptide concentration
timeFrame: baseline, after 3 months
measure: changes in HOMA-IR
timeFrame: baseline, after 3 months
measure: changes in parameters of lipid metabolism
timeFrame: baseline, after 3 months
measure: changes in the hepatic fat content
timeFrame: baseline, after 3 months
measure: changes in the hepatic fibrosis amount
timeFrame: baseline, after 3 months
measure: changes in parameters of hepatic function
timeFrame: baseline, after 3 months
measure: changes in bilirubin concentrations
timeFrame: baseline, after 3 months
measure: changes in the weight
timeFrame: baseline, after 3 months
measure: changes in the BMI
timeFrame: baseline, after 3 months
measure: changes in the anthropometric parameters
timeFrame: baseline, after 3 months
measure: changes in adipokine levels
timeFrame: baseline, after 3 months
measure: changes in depressive, anxiety and stress-related symptoms
timeFrame: baseline, after 3 months
measure: changes in quality of life
timeFrame: baseline, after 3 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References: