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Clinical Trials/NCT06330948
NCT06330948RecruitingNot Applicable

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

National Yang Ming Chiao Tung University2 sites in 1 country60 target enrollmentStarted: April 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
60
Locations
2
Primary Endpoint
GLUT4 gene expression

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
20 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Adults aged 20-
  • Fasting blood glucose level is between 100 ~ 126 mg/dL.

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

YenPing, Lei

Assistant professor

National Yang Ming Chiao Tung University

Study Sites (2)

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