The Efficacy of AP029 Mix in Patients With Impaired Carbohydrate Metabolism

The Effect of Mix AP029 on the Efficacy of Metformin Therapy and Its Side Effects in Patients With Type II Diabetes and on Mechanisms Related to Prediabetes in Patients With Impaired Carbohydrate-lipid Metabolism

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05994586

Enrollment

Registered

2023-08-16

Start date

2023-05-25

Completion date

2023-11-26

Last updated

2023-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes in Adolescence, PreDiabetes

Keywords

Type II diabetes, Prediabetes, Disorders of Carbohydrate Metabolism, Chokeberry, Elderberry

Brief summary

The aim of the study is to demonstrate that a daily supplementation of AP029 Mix: I) has a positive effect on reducing side effects of metformin, while enhancing the therapeutic effect of metformin; II) normalizes prediabetes biomarkers in order to prevent further progression into diabetes.

Detailed description

Randomized, double-blind, cross over study conducted under medical supervision on 1) group of 20 patients with type II diabetes and 2) group of 10 patients with prediabetes. Study design: 2 months of AP029 supplementation, 1 month wash-out, 2 months of placebo intake. Patients will attend 4 visits. On each visit, the following parameters are analyzed: level of glucose, insulin, HbA1c, hsCRP lipid panel (total cholesterol (TC), triglycerides (TG), low density lipoprotein (LDL), HDL) and inflammatory and oxidative stress markers. In addition, a questionnaire of symptoms associated with metformin intake will be conducted

Interventions

DIETARY_SUPPLEMENTAP029 mix

Polyphenol-rich plant extracts Twice a day

OTHERPlacebo

Twice a day

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

for type II diabetes: * Women and men, 18-75 years old * Patients diagnosed with type II diabetes mellitus * Patients on metformin treatment up to 5 months * BMI 20-35 kg/m2 * Signed informed consent Inclusion Criteria for prediabetes: * Women and men, 18-75 years old * BMI 20-35 kg/m2 * Fasting blood glucose levels between 100 mg/dl and 125 mg/dl (5.6-6.9 mmol/l) * Signed informed consent

Exclusion criteria

for type II diabetes: * Patients diagnosed with type I diabetes * Patients receiving insulin or other anti-diabetic medications * Women who are pregnant, planning to become pregnant during the study, or breastfeeding * Surgery within the last 6 months * Intake of dietary supplements containing plant extracts rich in polyphenols and anthocyanins * Intake of supplements containing: white mulberry, chromium, berberine * Patients receiving glucocorticosteroids, immunosuppressants * Oncological disease, autoimmune disease, severe liver dysfunction, tuberculosis, leukemia, multiple sclerosis, AIDS, rheumatoid arthritis, organ transplant * Acute inflammation (C-reactive protein \>20mg/dl)

Design outcomes

Primary

Measure	Time frame	Description
Glucose level	Baseline, 2 months, 3 months, 5 months	Comparison of glucose level
Insulin level	Baseline, 2 months, 3 months, 5 months	Comparison of insulin level
Discomfort related to metformin side effects	Baseline, 2 months, 3 months, 5 months	Based on questionnaire

Secondary

Measure	Time frame	Description
Lipid panel (total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL), HDL)	Baseline, 2 months, 3 months, 5 months	Comparison of lipid panel markers
hsCRP level	Baseline, 2 months, 3 months, 5 months	Comparison of hsCRP level
HbA1c level	Baseline, 2 months, 3 months, 5 months	Comparison of hbA1c level

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026