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NCT06437938

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

NCT ID: NCT06437938

Last Updated: 2024-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-25

Study Completion Date

2025-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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PreDiabetes

Keywords

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Prediabetes Dietary supplements

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Placebo group 1

Corresponding to dietary supplement groups B and C

Group Type PLACEBO_COMPARATOR

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

Intervention Type OTHER

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

Placebo group 2

Corresponding to dietary supplement A

Group Type PLACEBO_COMPARATOR

Placebo group 2: Placebo powder corresponding to Wasabi leaf powder

Intervention Type OTHER

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

Dietary supplement group A

Wasabi leaf powder

Group Type EXPERIMENTAL

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

Intervention Type DIETARY_SUPPLEMENT

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

Dietary supplement group B

Berberin Phytoactive Gold

Group Type PLACEBO_COMPARATOR

Dietary supplement B: Berberin Phytoactive Gold (product of BIOGENA GmbH & Co KG)

Intervention Type DIETARY_SUPPLEMENT

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

Dietary supplement group C

DiaPhyt® Formula 3.0

Group Type PLACEBO_COMPARATOR

Dietary supplement C: DiaPhyt® Formula 3.0 (product of BIOGENA GmbH & Co KG)

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BIOGENA GmbH

UNKNOWN

Sponsor Role collaborator

Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Michael Leutner

Priv.Doz. Dr.med.univ.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Medical University of Vienna

Vienna, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Michael Leutner

Role: CONTACT

Phone: 0140400

Email: [email protected]

Facility Contacts

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Michael Leutner, Priv.Doz. Dr.med.univ.

Role: primary

Other Identifiers

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1543/2023

Identifier Type: -

Identifier Source: org_study_id