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

NCT ID: NCT06224803

Last Updated: 2025-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-26

Study Completion Date

2022-01-18

Brief Summary

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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.

Detailed Description

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Conditions

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Type II Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Dibifree

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.

Group Type EXPERIMENTAL

Compound plant extracts

Intervention Type 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.

Control

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.

Group Type PLACEBO_COMPARATOR

Indigestible dextrin

Intervention Type DIETARY_SUPPLEMENT

Indigestible dextrin as placebo intervention

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Indigestible dextrin

Indigestible dextrin as placebo intervention

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Dibifree Control

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Global Preventive Medicine Biotech Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Global Preventive Medicine Biotech Co., Ltd.

New Taipei City, NEW TAIPEI, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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DF202006001

Identifier Type: -

Identifier Source: org_study_id

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