MedTrace Logo

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

NCT06437938 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-05-31

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • BIOGENA GmbH

    collaborator UNKNOWN

  • Medical University of Vienna

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-25
Primary Completion
2025-05-01
Completion
2025-08-31

Countries

  • Austria

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06437938 on ClinicalTrials.gov