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

Global Preventive Medicine Biotech Co., Ltd.56 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

Conditions

Type II Diabetes

Interventions

Compound plant extracts

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.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age: 20 years old (inclusive) or above, gender is not restricted 2. Diagnosed with type 2 diabetes 3. HbA1c \> 6.5% 4. Coagulation function and platelets are normal 5. Participants voluntarily join this treatment course and sign the informed consent form 6. Not taking other supplements containing blood sugar regulating properties for at least one month Exclusion Criteria: 1. Women who are pregnant, lactating or planning to have children 2. Have factors that significantly affect the absorption of oral drugs, such as inability to swallow, chronic diarrhea, intestinal obstruction, etc. 3. Uncontrolled hypertension (\>180/110 mmHG) 4. People suffering from stroke, elderly dementia, Alzheimer's disease and other brain diseases 5. During this study, the subject used other drugs or treatments that may interfere with this study in addition to blood sugar control medications. 6. GOT\>4 times normal value; GPT\>4 times normal value 7. Creatinine\>4 times the highest normal value 8. Those who are determined by the project administrator to be unfit to participate in this clinical study

Outcomes

Primary Outcomes

Concentration of HbA1c

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.

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

Body Weight and BMI

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.

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

Secondary Outcomes

Concentration of Blood Sugar

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.

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

Kidney Function Parameters: BUN, Creatinine, and eGFR

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.

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.

Liver Function Parameters: GOT and GPT

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.

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.

Concentration of blood lipid

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.

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