Effects of SugarCut® Unripe Guava Fruit Extract on Blood Glucose Regulation

PreDiabetes Clinical Trial

Official title:

Effects of SugarCut® Unripe Guava Fruit Extract on Blood Glucose Regulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06330948
• Other study ID #: NYCU112183AEF
• Status: Recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: January 2025

Study information

• Verified date: April 2024
• Source: National Yang Ming University
• Contact: ChienYU Huang, Bachelor
• Phone: +886-955-879163
• Email: chienyu.ns11[@]nycu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Adults aged 20-60.

2. Fasting blood glucose level is between 100 ~ 126 mg/dL.

Exclusion Criteria:

1. Patients with renal insufficiency and kidney dialysis.

2. Cancer patients.

3. Those taking blood sugar regulation-related drugs.

4. Have a history of guava allergy

5. People suffering from mental illness

6. Pregnant and breastfeeding women

7. Long-term use of blood sugar regulating supplements

Related Conditions & MeSH terms

• PreDiabetes
• Prediabetic State

Intervention

Dietary Supplement:
• SugarCut® Unripe Guava Fruit Extract
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 group
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.

Locations

Country	Name	City	State
Taiwan	National Yang Ming Chiao Tung University	Taipei	Beitou Dist.

Sponsors (1)

Lead Sponsor	Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 4 and 8
Primary	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)	Week 4 and 8