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

NCT06224803 | Completed

• 1 other identifier: DF202006001
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type II Diabetes

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

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

Secondary Outcomes (4)

• Concentration of Blood Sugar

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

• Concentration of blood lipid

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

Study Arms (2)

Dibifree

EXPERIMENTAL

Participants were instructed to consume ten Dibifree capsules each time, 5 to 10 minutes before meals, three times daily, for three months. This course of treatment was followed by a one-month washout period, after which Dibifree was resumed for an additional three months.

Dietary Supplement: Compound plant extracts

Control

PLACEBO COMPARATOR

Participants were instructed to take ten starch-containing placebo capsules 5 to 10 minutes before meals , three times daily, for three months. This was followed by a one-month washout period, after which participants switched to Dibifree treatment at the same dosage as the experimental group for another three months.

Dietary Supplement: Indigestible dextrin

Interventions

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.

Also known as: Dibifree

Dibifree

Indigestible dextrin DIETARY_SUPPLEMENT

Indigestible dextrin as placebo intervention

Also known as: Control

Control

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Global Preventive Medicine Biotech Co., Ltd.: lead

Study Sites (1)

Global Preventive Medicine Biotech Co., Ltd.

New Taipei City, NEW TAIPEI, 221416, Taiwan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Baseline physical examinations were conducted at the time of inclusion (V0), including assessments of fasting and postprandial blood sugar, HbA1c, body fat, blood urea nitrogen (BUN), creatinine (CRE), estimated glomerular filtration rate (eGFR), total cholesterol, HDL-cholesterol, LDL-cholesterol, Glutamic Oxaloacetic Transaminase (GOT), and Glutamic Pyruvic Transaminase (GPT). These parameters were routinely monitored in the third month (V3), fourth month (V4), and seventh month (V7). No adjustments were made to the diabetic routine medications during the clinical trial period.

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 25, 2024
• Study Start: August 26, 2020
• Primary Completion: July 21, 2021
• Study Completion: January 18, 2022
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)