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

PreDiabetes Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06437938
• Other study ID #: 1543/2023
• Status: Recruiting
• Phase: N/A
• Start date: April 25, 2024
• Est. completion date: August 31, 2025

Study information

• Verified date: May 2024
• Source: Medical University of Vienna
• Contact: Michael Leutner
• Phone: 0140400
• Email: michael.leutner[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 31, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Glucose Intolerance
• PreDiabetes
• Prediabetic State

Intervention

Dietary Supplement:
• Dietary supplement A: Wasabi leaf powder (product of BIOGENA GmbH & Co KG)
To be taken according to the information in the study protocol/patient information leaflet.
• Dietary supplement B: Berberin Phytoactive Gold (product of BIOGENA GmbH & Co KG)
To be taken according to the information in the study protocol/patient information leaflet.
• Dietary supplement C: DiaPhyt® Formula 3.0 (product of BIOGENA GmbH & Co KG)
To be taken according to the information in the study protocol/patient information leaflet.

Other:
• Placebo group 1: Placebo capsules corresponding to DiaPhyt® Formula 3.0/Berberin Phytoactive Gold
To be taken according to the information in the study protocol/patient information leaflet.
• Placebo group 2: Placebo powder corresponding to Wasabi leaf powder
To be taken according to the information in the study protocol/patient information leaflet.

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Vienna	BIOGENA GmbH

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in the time in range	time in range measured with continuous glucose monitoring system	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	changes in HbA1c values	HbA1c (glycated haemoglobin) values	baseline, after 3 months
Secondary	changes in fasting glucose concentration	fasting glucose concentration	baseline, after 3 months
Secondary	changes in fasting insulin concentration	fasting insulin concentration	baseline, after 3 months
Secondary	changes in fasting c-peptide concentration	fasting c-peptide concentration	baseline, after 3 months
Secondary	changes in HOMA-IR	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	baseline, after 3 months
Secondary	changes in parameters of lipid metabolism	HDL, LDL, triglycerides, total cholesterol, apolipoprotein B, chylomicrons	baseline, after 3 months
Secondary	changes in the hepatic fat content	hepatic fat content	baseline, after 3 months
Secondary	changes in the hepatic fibrosis amount	hepatic fibrosis amount	baseline, after 3 months
Secondary	changes in parameters of hepatic function	GGT (gamma-glutamyltransferase), GOT (AST, aspartate transaminase), GPT (ALT, alanine transaminase), alkaline phosphatase	baseline, after 3 months
Secondary	changes in bilirubin concentrations	bilirubin	baseline, after 3 months
Secondary	changes in the weight	weight	baseline, after 3 months
Secondary	changes in the BMI	BMI calculated as weight in kilograms divided by the square of height in meters	baseline, after 3 months
Secondary	changes in the anthropometric parameters	fat free mass, fat mass	baseline, after 3 months
Secondary	changes in adipokine levels	adiponectin, leptin	baseline, after 3 months
Secondary	changes in depressive, anxiety and stress-related symptoms	depressive, anxiety and stress-related symptoms assessed using the Depression-Anxiety-Stress Scale	baseline, after 3 months
Secondary	changes in quality of life	quality of life assessed using the World Health Organization Quality of Life (WHOQOL-BREF) questionnaire	baseline, after 3 months