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OpenTrials
Completed

NCT Number: NCT06224803

Evaluation of Effects of Dibifree® on Regulation of Blood Sugar and HbA1c in Patients With Type II Diabetes

At present, diabetic patients mainly use drugs to control blood sugar. However, drugs have side effects and the control effect varies among individuals. Even if diabetic patients can control their blood sugar well, long-term medication will still cause a series of complications, including retinopathy, nephropathy, diabetic foot, heart disease, etc. Vascular disease issues, etc.

This study will focus on the changes in HbA1c and blood sugar in patients with confirmed diabetes after taking "Dibifree®" food supplement.

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Key information

Conditions

Type II Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Global Preventive Medicine Biotech Co., Ltd.

New Taipei City, NEW TAIPEI, 221416, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 20 years old (inclusive) or above, gender is not restricted
  • Diagnosed with type 2 diabetes
  • HbA1c > 6.5%
  • Coagulation function and platelets are normal
  • Participants voluntarily join this treatment course and sign the informed consent form
  • Not taking other supplements containing blood sugar regulating properties for at least one month

Exclusion criteria

  • Women who are pregnant, lactating or planning to have children
  • Have factors that significantly affect the absorption of oral drugs, such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.
  • Uncontrolled hypertension (>180/110 mmHG)
  • People suffering from stroke, elderly dementia, Alzheimer's disease and other brain diseases
  • During this study, the subject used other drugs or treatments that may interfere with this study in addition to blood sugar control medications.
  • GOT>4 times normal value; GPT>4 times normal value
  • Creatinine>4 times the highest normal value
  • Those who are determined by the project administrator to be unfit to participate in this clinical study

Treatment and study plan

Compound plant extracts

Dietary Supplement

Total supplement including bitter melon (Momordica charantia) fruit extract, celery (Apium graveolens) seed extract, baker's yeast (Saccharomyces cerevisiae) cell wall extract, acerola (Malpighia emarginata) fruit extract, grape (Vitis vinifera) seed extract, green tea leaf extract, and hydrolyzed soy protein powder.

Other names: Dibifree

Indigestible dextrin

Dietary Supplement

Indigestible dextrin as placebo intervention

Other names: Control

Primary outcomes

  1. Concentration of HbA1c

    Time frame: HbA1c was measured at baseline (V0) and during follow-up visits at months 3 (V3), 4 (V4), and 7 (V7) after intervention.

    Hemoglobin A1c (HbA1c) levels were measured at baseline (V0) and routinely monitored at the third (V3), fourth (V4), and seventh (V7) months. For longitudinal analysis, repeated measures were evaluated using two-way ANOVA followed by Sidak's multiple comparisons test to assess time and treatment effects. Data are presented as mean ± SD. All statistical analyses were performed using GraphPad Prism 10 (GraphPad Software, San Diego, CA, USA). All data were considered statistically significant at p ≤ 0.05.

  2. Body Weight and BMI

    Time frame: Body weight and BMI were measured at baseline (V0) and at the end of the 7-month intervention (V7).

    Changes in body weight and BMI between baseline (V0) and month 7 (V7) were analyzed using an unpaired t-test. Statistical analyses were conducted using GraphPad Prism 10 (GraphPad Software, San Diego, CA, USA), with p ≤ 0.05 considered statistically significant.

Secondary outcomes

  1. Concentration of Blood Sugar

    Time frame: measured at baseline (V0) and during follow-up visits at months 3 (V3), 4 (V4), and 7 (V7) after intervention.

    AC & PC blood sugar levels were measured at baseline (V0) and routinely monitored at the third (V3), fourth (V4), and seventh (V7) months. For longitudinal analysis, repeated measures were evaluated using two-way ANOVA followed by Sidak's multiple comparisons test to assess time and treatment effects. Data are presented as mean ± SD. All statistical analyses were performed using GraphPad Prism 10 (GraphPad Software, San Diego, CA, USA). All data were considered statistically significant at p ≤ 0.05.

  2. Kidney Function Parameters: BUN, Creatinine, and eGFR

    Time frame: Kidney function parameters measured at baseline (V0) and during follow-up visits at months 3 (V3), 4 (V4), and 7 (V7) after intervention.

    Kidney Function Parameters were measured at baseline (V0) and routinely monitored at the third (V3), fourth (V4), and seventh (V7) months. For longitudinal analysis, repeated measures were evaluated using two-way ANOVA followed by Sidak's multiple comparisons test to assess time and treatment effects. Data are presented as mean ± SD. All statistical analyses were performed using GraphPad Prism 10 (GraphPad Software, San Diego, CA, USA). All data were considered statistically significant at p ≤ 0.05.

  3. Liver Function Parameters: GOT and GPT

    Time frame: Liver function parameters measured at baseline (V0) and during follow-up visits at months 3 (V3), 4 (V4), and 7 (V7) after intervention.

    Liver Function Parameters were measured at baseline (V0) and routinely monitored at the third (V3), fourth (V4), and seventh (V7) months. For longitudinal analysis, repeated measures were evaluated using two-way ANOVA followed by Sidak's multiple comparisons test to assess time and treatment effects. Data are presented as mean ± SD. All statistical analyses were performed using GraphPad Prism 10 (GraphPad Software, San Diego, CA, USA). All data were considered statistically significant at p ≤ 0.05.

  4. Concentration of blood lipid

    Time frame: The measurement at baseline (V0) and during follow-up visits at months 3 (V3), 4 (V4), and 7 (V7) after intervention.

    Total cholesterol, HDL-cholesterol, and LDL-cholesterol were measured at baseline (V0) and routinely monitored at the third (V3), fourth (V4), and seventh (V7) months. For longitudinal analysis, repeated measures were evaluated using two-way ANOVA followed by Sidak's multiple comparisons test to assess time and treatment effects. Data are presented as mean ± SD. All statistical analyses were performed using GraphPad Prism 10 (GraphPad Software, San Diego, CA, USA). All data were considered statistically significant at p ≤ 0.05.

Sponsors and collaborators

Lead sponsor

Global Preventive Medicine Biotech Co., Ltd.

Industry

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jan 25, 2024
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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