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

NCT ID: NCT06330948

Last Updated: 2024-04-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-30
• Study Completion Date: 2025-01-31

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

placebo group

Placebo group (50mL/bottle)

Group Type: PLACEBO_COMPARATOR

Placebo group

Intervention Type: DIETARY_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.

SugarCut® Unripe Guava Fruit Extract

SugarCut® Guava Fruit Extract Group (50mL/bottle, each bottle contains 10g Guava Fruit Extract)

Group Type: EXPERIMENTAL

SugarCut® Unripe Guava Fruit Extract

Intervention Type: DIETARY_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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Yang Ming Chiao Tung University

OTHER

Sponsor Role: lead

Responsible Party

YenPing, Lei

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

National Yang Ming Chiao Tung University

Taipei, Beitou Dist., Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

ChienYU Huang, Bachelor

Role: CONTACT

chienyu.ns11@nycu.edu.tw

+886-955-879163

Facility Contacts

Tze-Fang Wang, Ph.D.

Role: primary

tzefang@nycu.edu.tw

+886-2-28267907

Other Identifiers

NYCU112183AEF

Identifier Type: -

Identifier Source: org_study_id