## Protocol Section
### Identification Module
**NCT ID:** NCT06437938

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

**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

#### Organization Study ID Info
**ID:** 1543/2023
#### Organization
**Class:** OTHER
**Full Name:** Medical University of Vienna
### Status Module
#### Completion Date
**Date:** 2025-08-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-26

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-05-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04-25

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-26
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** BIOGENA GmbH

#### Lead Sponsor

**Class:** OTHER

**Name:** Medical University of Vienna

#### Responsible Party

**Investigator Affiliation:** Medical University of Vienna

**Investigator Full Name:** Michael Leutner

**Investigator Title:** Priv.Doz. Dr.med.univ.

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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 Module

**Conditions:**

- PreDiabetes

**Keywords:**

- Prediabetes

- Dietary supplements

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Corresponding to dietary supplement groups B and C

**Intervention Names:**

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

**Label:** Placebo group 1

**Type:** PLACEBO_COMPARATOR

#### Arm Group 2

**Description:** Corresponding to dietary supplement A

**Intervention Names:**

- Other: Placebo group 2: Placebo powder corresponding to Wasabi leaf powder

**Label:** Placebo group 2

**Type:** PLACEBO_COMPARATOR

#### Arm Group 3

**Description:** Wasabi leaf powder

**Intervention Names:**

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

**Label:** Dietary supplement group A

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** Berberin Phytoactive Gold

**Intervention Names:**

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

**Label:** Dietary supplement group B

**Type:** PLACEBO_COMPARATOR

#### Arm Group 5

**Description:** DiaPhyt® Formula 3.0

**Intervention Names:**

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

**Label:** Dietary supplement group C

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Dietary supplement group A

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

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

**Type:** DIETARY_SUPPLEMENT

#### Intervention 2

**Arm Group Labels:**

- Dietary supplement group B

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

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

**Type:** DIETARY_SUPPLEMENT

#### Intervention 3

**Arm Group Labels:**

- Dietary supplement group C

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

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

**Type:** DIETARY_SUPPLEMENT

#### Intervention 4

**Arm Group Labels:**

- Placebo group 1

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

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

**Type:** OTHER

#### Intervention 5

**Arm Group Labels:**

- Placebo group 2

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

**Name:** Placebo group 2: Placebo powder corresponding to Wasabi leaf powder

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** time in range measured with continuous glucose monitoring system

**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

#### Secondary Outcomes

**Description:** HbA1c (glycated haemoglobin) values

**Measure:** changes in HbA1c values

**Time Frame:** baseline, after 3 months

**Description:** fasting glucose concentration

**Measure:** changes in fasting glucose concentration

**Time Frame:** baseline, after 3 months

**Description:** fasting insulin concentration

**Measure:** changes in fasting insulin concentration

**Time Frame:** baseline, after 3 months

**Description:** fasting c-peptide concentration

**Measure:** changes in fasting c-peptide concentration

**Time Frame:** baseline, after 3 months

**Description:** 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

**Measure:** changes in HOMA-IR

**Time Frame:** baseline, after 3 months

**Description:** HDL, LDL, triglycerides, total cholesterol, apolipoprotein B, chylomicrons

**Measure:** changes in parameters of lipid metabolism

**Time Frame:** baseline, after 3 months

**Description:** hepatic fat content

**Measure:** changes in the hepatic fat content

**Time Frame:** baseline, after 3 months

**Description:** hepatic fibrosis amount

**Measure:** changes in the hepatic fibrosis amount

**Time Frame:** baseline, after 3 months

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

**Measure:** changes in parameters of hepatic function

**Time Frame:** baseline, after 3 months

**Description:** bilirubin

**Measure:** changes in bilirubin concentrations

**Time Frame:** baseline, after 3 months

**Description:** weight

**Measure:** changes in the weight

**Time Frame:** baseline, after 3 months

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

**Measure:** changes in the BMI

**Time Frame:** baseline, after 3 months

**Description:** fat free mass, fat mass

**Measure:** changes in the anthropometric parameters

**Time Frame:** baseline, after 3 months

**Description:** adiponectin, leptin

**Measure:** changes in adipokine levels

**Time Frame:** baseline, after 3 months

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

**Measure:** changes in depressive, anxiety and stress-related symptoms

**Time Frame:** baseline, after 3 months

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

**Measure:** changes in quality of life

**Time Frame:** baseline, after 3 months

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 80 Years

**Minimum Age:** 40 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** michael.leutner@meduniwien.ac.at

**Name:** Michael Leutner

**Phone:** 0140400

**Phone Ext:** 20690

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Vienna

**Contacts:**

***Contact 1:***

- **Email:** michael.leutner@meduniwien.ac.at

- **Name:** Michael Leutner, Priv.Doz. Dr.med.univ.

- **Phone:** 0140400

- **Phone Ext:** 20690

- **Role:** CONTACT

***Contact 2:***

- **Name:** Dorota Sluková, Dr.med.univ.

- **Role:** SUB_INVESTIGATOR

**Country:** Austria

**Facility:** Medical University of Vienna

**Status:** RECRUITING

**Zip:** 1090

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000003920

- Term: Diabetes Mellitus

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000006943

- Term: Hyperglycemia

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M14117

- Name: Prediabetic State

- Relevance: HIGH

- As Found: Prediabetes

- ID: M20295

- Name: Glucose Intolerance

- Relevance: HIGH

- As Found: Prediabetes

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9994

- Name: Hyperglycemia

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011236

- Term: Prediabetic State

- ID: D000018149

- Term: Glucose Intolerance

### Misc Info Module

- Version Holder: 2024-05-31
