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

Medical University of Vienna

Status: Enrolling

Conditions: PreDiabetes

Treatments: Other: Placebo group 1: Placebo capsules corresponding to DiaPhyt® Formula 3.0/Berberin Phytoactive Gold; Dietary Supplement: Dietary supplement C: DiaPhyt® Formula 3.0 (product of BIOGENA GmbH & Co KG); Dietary Supplement: Dietary supplement A: Wasabi leaf powder (product of BIOGENA GmbH & Co KG); Other: Placebo group 2: Placebo powder corresponding to Wasabi leaf powder; Dietary Supplement: Dietary supplement B: Berberin Phytoactive Gold (product of BIOGENA GmbH & Co KG)

Study type: Interventional

Funder types: Other

Identifiers

NCT06437938

1543/2023

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 5 patient groups, including a placebo group

Placebo group 1

Placebo Comparator group

Description:

Corresponding to dietary supplement groups B and C

Treatment:

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

Placebo group 2

Placebo Comparator group

Description:

Corresponding to dietary supplement A

Treatment:

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

Dietary supplement group A

Experimental group

Description:

Wasabi leaf powder

Treatment:

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

Dietary supplement group B

Placebo Comparator group

Description:

Berberin Phytoactive Gold

Treatment:

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

Dietary supplement group C

Placebo Comparator group

Description:

DiaPhyt® Formula 3.0

Treatment:

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