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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of Vienna

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 25, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 31, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 31, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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