Effectiveness of Pumpkin Seed Extract on Improving Blood Sugar Level in Subhealth Subjects

Diabetes Clinical Trial

Official title:

Effectiveness of Pumpkin Seed Extract on Improving Blood Sugar Level in Subhealth Subjects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05738655
• Other study ID #: A-111-110
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: October 31, 2024

Study information

• Verified date: February 2024
• Source: Greenyn Biotechnology Co., Ltd.
• Contact: Ming-Shun Wu, MD
• Phone: +886-229307930
• Email: mswu[@]tmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized, double-blind, placebo-controlled, and parallel clinical study aims to investigate the effectivness of a pumpkin seed extract on blood sugar management in subhealth people.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• Fasting blood sugar levels from 100 to 125 mg/dL

• Glycated hemoglobin levels from 5.7 to 6.4%

• 2-hour OGTT levels from 140 to 199 mg/dL

Exclusion Criteria:

• Pregnant women or preparing for pregnancy.

• Lactating women.

• Women gave birth 6 months before the study.

• Poor kindy funciton

• Severe cardiovascular or other chronic diseases

• Patients with type I or II diabetes

• Poor compliance

• Alcohol abuser

• Using anti-diabetic or weight managent supplements

• Blood transfusion three months before the study

• Pumpkin seed allergy

Related Conditions & MeSH terms

• Diabetes
• Metabolic Disease
• Metabolic Diseases

Intervention

Dietary Supplement:
• Pumpkin seed extract (Low dose)
Pumpkin seed extract standardized with specific peptides (300 mg/day)
• Pumpkin seed extract (High dose)
Pumpkin seed extract standardized with specific peptides (600 mg/day)
• Placebo
Placeo (300 mg/day)

Locations

Country	Name	City	State
Taiwan	WanFang Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Greenyn Biotechnology Co., Ltd.	Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemical analysis	Changes in fasting blodd sugar levels of 60 pariticpants will be analyzed between baseline and week 12.	Baseline up to 12 weeks
Primary	Biochemical analysis	Changes in glycosylated hemoglobin levels of 60 pariticpants will be analyzed between baseline and week 12.	Baseline up to 12 weeks
Primary	Biochemical analysis	Changes in insulin levels of 60 pariticpants will be analyzed between baseline and week 12.	Baseline up to 12 weeks
Primary	Biochemical analysis	Changes in incremental area under the curve for glucose for 60 pariticpants will be analyzed between baseline and week 12.	Baseline up to 12 weeks
Primary	Hormone analysis	Changes in GLP-1 levels of 60 pariticpants will be analyzed between baseline and week 12.	Baseline up to 12 weeks
Primary	Hormone analysis	Changes in DPP4 levels of 60 pariticpants will be analyzed between baseline and week 12.	Baseline up to 12 weeks
Primary	Hormone analysis	Changes in adiponectin levels of 60 pariticpants will be analyzed between baseline and week 12.	Baseline up to 12 weeks