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PreDiabetesNCT06437938

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

A study testing Dietary supplement A: Wasabi leaf powder (product of BIOGENA GmbH & Co KG), Dietary supplement B: Berberin Phytoactive Gold (product of BIOGENA GmbH & Co KG) and Dietary supplement C: DiaPhyt® Formula 3.0 (product of BIOGENA GmbH & Co KG) in people with PreDiabetes, run by Medical University of Vienna at 1 site in Austria.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
PreDiabetes
What is being tested?
Dietary supplement A: Wasabi leaf powder (product of BIOGENA GmbH & Co KG), Dietary supplement B: Berberin Phytoactive Gold (product of BIOGENA GmbH & Co KG) and Dietary supplement C: DiaPhyt® Formula 3.0 (product of BIOGENA GmbH & Co KG)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 siteAustria
Study dates
25 Apr 2024to 31 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Michael Leutner contact

0140400 ext. 20690

michael.leutner@meduniwien.ac.at

Austria1 site, 1 recruiting

  • Medical University of Vienna

    Vienna, 1090

    Michael Leutner, Priv.Doz. Dr.med.univ., 0140400 ext. 20690, michael.leutner@meduniwien.ac.at

    Dorota Sluková, Dr.med.univ.

    Recruiting

Other trials in Austria

About this study

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

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
Being tested
Dietary supplement A: Wasabi leaf powder (product of BIOGENA GmbH & Co KG), Dietary supplement B: Berberin Phytoactive Gold (product of BIOGENA GmbH & Co KG), Dietary supplement C: DiaPhyt® Formula 3.0 (product of BIOGENA GmbH & Co KG), Placebo group 1: Placebo capsules corresponding to DiaPhyt® Formula 3.0/Berberin Phytoactive Gold, Placebo group 2: Placebo powder corresponding to Wasabi leaf powder
Keywords
Prediabetes, Dietary supplements
Medical subject headings
Prediabetic State

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dietary supplement A: Wasabi leaf powder (product of BIOGENA GmbH & Co KG)Dietary supplement

    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)Dietary supplement

    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)Dietary supplement

    To be taken according to the information in the study protocol/patient information leaflet.

  • Placebo group 1: Placebo capsules corresponding to DiaPhyt® Formula 3.0/Berberin Phytoactive GoldOther

    To be taken according to the information in the study protocol/patient information leaflet.

  • Placebo group 2: Placebo powder corresponding to Wasabi leaf powderOther

    To be taken according to the information in the study protocol/patient information leaflet.

Study groups in NCT06437938
Study groupRoleWhat they receive
Placebo group 1Placebo comparatorCorresponding to dietary supplement groups B and C
Receives: Other: Placebo group 1: Placebo capsules corresponding to DiaPhyt® Formula 3.0/Berberin Phytoactive Gold
Placebo group 2Placebo comparatorCorresponding to dietary supplement A
Receives: Other: Placebo group 2: Placebo powder corresponding to Wasabi leaf powder
Dietary supplement group AExperimentalWasabi leaf powder
Receives: Dietary Supplement: Dietary supplement A: Wasabi leaf powder (product of BIOGENA GmbH & Co KG)
Dietary supplement group BPlacebo comparatorBerberin Phytoactive Gold
Receives: Dietary Supplement: Dietary supplement B: Berberin Phytoactive Gold (product of BIOGENA GmbH & Co KG)
Dietary supplement group CPlacebo comparatorDiaPhyt® Formula 3.0
Receives: Dietary Supplement: Dietary supplement C: DiaPhyt® Formula 3.0 (product of BIOGENA GmbH & Co KG)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. changes in the time in range

    time in range measured with continuous glucose monitoring system

    Measured: 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 outcomes (16)

  1. changes in HbA1c values

    HbA1c (glycated haemoglobin) values

    Measured: baseline, after 3 months

  2. changes in fasting glucose concentration

    fasting glucose concentration

    Measured: baseline, after 3 months

  3. changes in fasting insulin concentration

    fasting insulin concentration

    Measured: baseline, after 3 months

  4. changes in fasting c-peptide concentration

    fasting c-peptide concentration

    Measured: baseline, after 3 months

  5. 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

    Measured: baseline, after 3 months

  6. changes in parameters of lipid metabolism

    HDL, LDL, triglycerides, total cholesterol, apolipoprotein B, chylomicrons

    Measured: baseline, after 3 months

  7. changes in the hepatic fat content

    hepatic fat content

    Measured: baseline, after 3 months

  8. changes in the hepatic fibrosis amount

    hepatic fibrosis amount

    Measured: baseline, after 3 months

  9. changes in parameters of hepatic function

    GGT (gamma-glutamyltransferase), GOT (AST, aspartate transaminase), GPT (ALT, alanine transaminase), alkaline phosphatase

    Measured: baseline, after 3 months

  10. changes in bilirubin concentrations

    bilirubin

    Measured: baseline, after 3 months

  11. changes in the weight

    weight

    Measured: baseline, after 3 months

  12. changes in the BMI

    BMI calculated as weight in kilograms divided by the square of height in meters

    Measured: baseline, after 3 months

  13. changes in the anthropometric parameters

    fat free mass, fat mass

    Measured: baseline, after 3 months

  14. changes in adipokine levels

    adiponectin, leptin

    Measured: baseline, after 3 months

  15. changes in depressive, anxiety and stress-related symptoms

    depressive, anxiety and stress-related symptoms assessed using the Depression-Anxiety-Stress Scale

    Measured: baseline, after 3 months

  16. changes in quality of life

    quality of life assessed using the World Health Organization Quality of Life (WHOQOL-BREF) questionnaire

    Measured: baseline, after 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2024
  2. Study start25 Apr 2024
  3. Primary completion1 May 2025 (estimated)
  4. Study completion31 Aug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06437938
Sponsor's protocol ID
1543/2023
Status last verified
May 2024
First submitted
16 May 2024
Last updated
31 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Dietary supplement A: Wasabi leaf powder (product of BIOGENA GmbH & Co KG), Dietary supplement B: Berberin Phytoactive Gold (product of BIOGENA GmbH & Co KG) and Dietary supplement C: DiaPhyt® Formula 3.0 (product of BIOGENA GmbH & Co KG) in people with PreDiabetes, run by Medical University of Vienna at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Michael Leutner (0140400 ext. 20690, michael.leutner@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06437938.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2024.

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