PreDiabetesNCT06330948
Effects of SugarCut® Unripe Guava Fruit Extract on Blood Glucose Regulation
A study testing SugarCut® Unripe Guava Fruit Extract in people with PreDiabetes, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
Guava (Psidium guajava) belongs to the Myrtle family. It is a tropical and subtropical fruit native to the Americas. Ripe guava fruit is sweet and delicious. It is rich in vitamins A, C and trace elements such as phosphorus, calcium and magnesium. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- PreDiabetes
- What is being tested?
- SugarCut® Unripe Guava Fruit Extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2024to Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged 20-60.
- Fasting blood glucose level is between 100 ~ 126 mg/dL.
Who cannot join
- Patients with renal insufficiency and kidney dialysis.
- Cancer patients.
- Those taking blood sugar regulation-related drugs.
- Have a history of guava allergy
- People suffering from mental illness
- Pregnant and breastfeeding women
- Long-term use of blood sugar regulating supplements
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Yang Ming Chiao Tung University
Taipei, Beitou Dist., 112
Tze-Fang Wang, Ph.D., +886-2-28267907, tzefang@nycu.edu.tw
About this study
Guava (Psidium guajava) belongs to the Myrtle family. It is a tropical and subtropical fruit native to the Americas. Ripe guava fruit is sweet and delicious. It is rich in vitamins A, C and trace elements such as phosphorus, calcium and magnesium. In traditional medicine, guava fruit can be eaten raw, and the roots can treat stomach problems, abdominal pain, dysentery, and diabetes; the leaves can treat diabetes, abdominal pain, rheumatism, antipyretic, stomachache, anthelmintic, cholera, vomiting, diarrhea, enteritis and other symptoms. Guava leaf extract contains polyphenols. Studies have shown that guava leaf has antioxidant, blood sugar regulating and anti-cancer effects. Not only guava leaves, research has found that guava fruits are rich in vitamins, fiber and antioxidants, which have anti-inflammatory and anti-cancer effects. Preliminary research has found that the extract of red guava young fruit has more active ingredients - saponins and total polyphenol content, and its antioxidant capacity is also higher than that of mature guava. In vitro studies have found that guava fruit extract can increase the expression of GLUT4 gene and promote the entry of blood sugar into cells. At the same time, guava fruit extract can inhibit the formation of final glycated proteins (AGEs). The purpose of this study is to explore the effect of guava fruit extract on blood sugar regulation in humans and to evaluate its potential to be developed as a blood sugar regulation supplement.
Read the detailed description
This trial adopted a double-blind placebo-controlled parallel testing design. Subjects will be randomly assigned to the placebo group and the SugarCut® Guava Extract group, with 30 people in each group. Before the trial (week 0), subjects are required to undergo fasting blood collection and height, weight, and blood pressure examinations. Afterwards, the test samples were given to the subjects for 8 consecutive weeks, and they were reviewed for evaluation at the 4th and 8th weeks, and fasting blood collection and height, weight, and blood pressure examinations were performed.
- Conditions
- PreDiabetes
- Being tested
- SugarCut® Unripe Guava Fruit Extract, Placebo group
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SugarCut® Unripe Guava Fruit ExtractDietary supplement
This trial adopted a double-blind placebo-controlled parallel testing design. Subjects will be randomly assigned to the SugarCut® Guava Extract group. Before the trial (week 0), subjects are required to undergo fasting blood collection and height, weight, and blood pressure examinations. Afterwards, the test samples were given to the subjects for 8 consecutive weeks, and they were reviewed for evaluation at the 4th and 8th weeks, and fasting blood collection and height, weight, and blood pressure examinations were performed.
Placebo groupDietary supplement
This trial adopted a double-blind placebo-controlled parallel testing design. Subjects will be randomly assigned to the placebo group. Before the trial (week 0), subjects are required to undergo fasting blood collection and height, weight, and blood pressure examinations. Afterwards, the test samples were given to the subjects for 8 consecutive weeks, and they were reviewed for evaluation at the 4th and 8th weeks, and fasting blood collection and height, weight, and blood pressure examinations were performed.
| Study group | Role | What they receive |
|---|---|---|
| placebo group | Placebo comparator | Placebo group (50mL/bottle) Receives: Dietary Supplement: Placebo group |
| SugarCut® Unripe Guava Fruit Extract | Experimental | SugarCut® Guava Fruit Extract Group (50mL/bottle, each bottle contains 10g Guava Fruit Extract) Receives: Dietary Supplement: SugarCut® Unripe Guava Fruit Extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
GLUT4 gene expression
GLUT4 expression is exquisitely regulated in muscle and this seems important in the regulation of insulin-stimulated glucose uptake by this tissues. Thus, muscle GLUT4 overexpression in transgenic animals ameliorates insulin resistance associated with obesity or diabetes.
Measured: Week 4 and 8
Hematology Test
Fasting blood glucose, HbA1c, insulin, final glycated proteins (AGEs), triglycerides, total cholesterol, Blood urea nitrogen, Creatinine, Uric acid, GOT, GPT, Low glucagon-like peptide-1 (GLP-1)
Measured: Week 4 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study startApr 2024 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YenPing, Lei, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06330948
- Sponsor's protocol ID
- NYCU112183AEF
- Status last verified
- Apr 2024
- First submitted
- 5 Mar 2024
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of SugarCut® Unripe Guava Fruit Extract on Blood Glucose Regulation
- ClinicalTrials.gov ID
- NCT06330948
- Acronym / sponsor ID
- NYCU112183AEF
- Conditions
- PreDiabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- Apr 2024 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 26 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Guava (Psidium guajava) belongs to the Myrtle family. It is a tropical and subtropical fruit native to the Americas. Ripe guava fruit is sweet and delicious. It is rich in vitamins A, C and trace elements such as phosphorus, calcium and magnesium. In traditional medicine, guava fruit can be eaten raw, and the roots can treat stomach problems, abdominal pain, dysentery, and diabetes; the leaves can treat diabetes, abdominal pain, rheumatism, antipyretic, stomachache, anthelmintic, cholera, vomiting, diarrhea, enteritis and other symptoms. Guava leaf extract contains polyphenols. Studies have shown that guava leaf has antioxidant, blood sugar regulating and anti-cancer effects. Not only guava leaves, research has found that guava fruits are rich in vitamins, fiber and antioxidants, which have anti-inflammatory and anti-cancer effects. Preliminary research has found that the extract of red guava young fruit has more active ingredients - saponins and total polyphenol content, and its antioxidant capacity is also higher than that of mature guava. In vitro studies have found that guava fruit extract can increase the expression of GLUT4 gene and promote the entry of blood sugar into cells. At the same time, guava fruit extract can inhibit the formation of final glycated proteins (AGEs). The purpose of this study is to explore the effect of guava fruit extract on blood sugar regulation in humans and to evaluate its potential to be developed as a blood sugar regulation supplement.
Detailed description
This trial adopted a double-blind placebo-controlled parallel testing design. Subjects will be randomly assigned to the placebo group and the SugarCut® Guava Extract group, with 30 people in each group. Before the trial (week 0), subjects are required to undergo fasting blood collection and height, weight, and blood pressure examinations. Afterwards, the test samples were given to the subjects for 8 consecutive weeks, and they were reviewed for evaluation at the 4th and 8th weeks, and fasting blood collection and height, weight, and blood pressure examinations were performed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo group | Placebo comparator | Dietary Supplement: Placebo groupPlacebo group (50mL/bottle) |
| SugarCut® Unripe Guava Fruit Extract | Experimental | Dietary Supplement: SugarCut® Unripe Guava Fruit ExtractSugarCut® Guava Fruit Extract Group (50mL/bottle, each bottle contains 10g Guava Fruit Extract) |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Adults aged 20-60.
- Fasting blood glucose level is between 100 ~ 126 mg/dL.
Key exclusion criteria (7 listed)
- Patients with renal insufficiency and kidney dialysis.
- Cancer patients.
- Those taking blood sugar regulation-related drugs.
- Have a history of guava allergy
- People suffering from mental illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SugarCut® Unripe Guava Fruit ExtractThis trial adopted a double-blind placebo-controlled parallel testing design. Subjects will be randomly assigned to the SugarCut® Guava Extract group. Before the trial (week 0), subjects are required to undergo fasting blood collection and height, weight, and blood pressure examinations. Afterwards, the test samples were given to the subjects for 8 consecutive weeks, and they were reviewed for evaluation at the 4th and 8th weeks, and fasting blood collection and height, weight, and blood pressure examinations were performed. | Dietary supplement | SugarCut® Unripe Guava Fruit Extract |
| Placebo groupThis trial adopted a double-blind placebo-controlled parallel testing design. Subjects will be randomly assigned to the placebo group. Before the trial (week 0), subjects are required to undergo fasting blood collection and height, weight, and blood pressure examinations. Afterwards, the test samples were given to the subjects for 8 consecutive weeks, and they were reviewed for evaluation at the 4th and 8th weeks, and fasting blood collection and height, weight, and blood pressure examinations were performed. | Dietary supplement | placebo group |
Primary outcome
GLUT4 gene expression
Time frame: Week 4 and 8
GLUT4 expression is exquisitely regulated in muscle and this seems important in the regulation of insulin-stimulated glucose uptake by this tissues. Thus, muscle GLUT4 overexpression in transgenic animals ameliorates insulin resistance associated with obesity or diabetes.
Hematology Test
Time frame: Week 4 and 8
Fasting blood glucose, HbA1c, insulin, final glycated proteins (AGEs), triglycerides, total cholesterol, Blood urea nitrogen, Creatinine, Uric acid, GOT, GPT, Low glucagon-like peptide-1 (GLP-1)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SugarCut® Unripe Guava Fruit Extract in people with PreDiabetes, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ChienYU Huang, Bachelor (+886-955-879163, chienyu.ns11@nycu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GLUT4 gene expression (time frame: Week 4 and 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2024.