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

May 26, 2024 updated by: Michael Leutner, Medical University of Vienna

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Recruiting
        • Medical University of Vienna
        • Contact:
        • Sub-Investigator:
          • Dorota Sluková, Dr.med.univ.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo group 1
Corresponding to dietary supplement groups B and C
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 Comparator: Placebo group 2
Corresponding to dietary supplement A
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.
Experimental: Dietary supplement group A
Wasabi leaf powder
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.
Placebo Comparator: Dietary supplement group B
Berberin Phytoactive Gold
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.
Placebo Comparator: Dietary supplement group C
DiaPhyt® Formula 3.0
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in the time in range
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
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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Collaborators

BIOGENA GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2024

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

August 31, 2025

Study Registration Dates

First Submitted

May 16, 2024

First Submitted That Met QC Criteria

May 26, 2024

First Posted (Actual)

May 31, 2024

Study Record Updates

Last Update Posted (Actual)

May 31, 2024

Last Update Submitted That Met QC Criteria

May 26, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1543/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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