NCT06437938

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• PreDiabetes

Interventions

Type	Name	Description
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	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	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.
OTHER	Placebo group 2: Placebo powder corresponding to Wasabi leaf powder	To be taken according to the information in the study protocol/patient information leaflet.

Timeline

• Start date: 2024-04-25
• Primary completion: 2025-05-01
• Completion: 2025-08-31
• First posted: 2024-05-31
• Last updated: 2024-05-31

Locations

1 site across 1 country: Austria