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
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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COMPLETED
NA
56 participants
INTERVENTIONAL
2020-08-26
2022-01-18
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
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.
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.
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.
Indigestible dextrin
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.
Indigestible dextrin
Indigestible dextrin as placebo intervention
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
ALL
No
Sponsors
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Global Preventive Medicine Biotech Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Global Preventive Medicine Biotech Co., Ltd.
New Taipei City, NEW TAIPEI, Taiwan
Countries
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Other Identifiers
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DF202006001
Identifier Type: -
Identifier Source: org_study_id
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