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

NCT06437938 | Recruiting

• 1 other identifier: 1543/2023
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

PreDiabetes

Keywords

Prediabetes; Dietary supplements

Outcome Measures

Primary Outcomes (1)

• changes in the time in range

  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 Outcomes (16)

• changes in HbA1c values

  baseline, after 3 months

• changes in fasting glucose concentration

  baseline, after 3 months

• changes in fasting insulin concentration

  baseline, after 3 months

• changes in fasting c-peptide concentration

  baseline, after 3 months

• changes in HOMA-IR

  baseline, after 3 months

Study Arms (5)

Placebo group 1

PLACEBO COMPARATOR

Corresponding to dietary supplement groups B and C

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

Placebo group 2

PLACEBO COMPARATOR

Corresponding to dietary supplement A

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

Dietary supplement group A

EXPERIMENTAL

Wasabi leaf powder

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

Dietary supplement group B

PLACEBO COMPARATOR

Berberin Phytoactive Gold

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

Dietary supplement group C

PLACEBO COMPARATOR

DiaPhyt® Formula 3.0

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

Interventions

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 group A

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 group B

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.

Dietary supplement group C

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

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

Placebo group 1

Placebo group 2: Placebo powder corresponding to Wasabi leaf powder OTHER

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

Placebo group 2

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%
• BMI between 25 and 35 kg/m2
• fasting glucose of 100-125mg/dl

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead
• BIOGENA GmbH: collaborator

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Michael Leutner

CONTACT

0140400; michael.leutner@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Priv.Doz. Dr.med.univ.

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 31, 2024
• Study Start: April 25, 2024
• Primary Completion: May 1, 2025
• Study Completion: August 31, 2025
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)