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

February 21, 2024 updated by: Greenyn Biotechnology Co., Ltd.
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ming-Shun Wu, MD
  • Phone Number: +886-229307930
  • Email: mswu@tmu.edu.tw

Study Locations

  • Taiwan
      • Taipei, Taiwan, 116
        • Recruiting
        • Wanfang Hospital
        • Principal Investigator:
          • Ming-Shun Wu, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo group
Placebo capsule, one capsule/day (300 mg/day) for 3 months
Dietary supplement: Placebo
Placeo (300 mg/day)
Experimental: Low dose
Pumpkin seed extract capsule, one capsule/day (300 mg/day) for 3 months
Dietary supplement: Pumpkin seed extract (Low dose)
Pumpkin seed extract standardized with specific peptides (300 mg/day)
Experimental: High dose
Pumpkin seed extract capsule, two capsules/day (600 mg/day) for 3 months
Dietary supplement: Pumpkin seed extract (High dose)
Pumpkin seed extract standardized with specific peptides (600 mg/day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biochemical analysis
Time Frame: Baseline up to 12 weeks
Changes in fasting blodd sugar levels of 60 pariticpants will be analyzed between baseline and week 12.
Baseline up to 12 weeks
Biochemical analysis
Time Frame: Baseline up to 12 weeks
Changes in glycosylated hemoglobin levels of 60 pariticpants will be analyzed between baseline and week 12.
Baseline up to 12 weeks
Biochemical analysis
Time Frame: Baseline up to 12 weeks
Changes in insulin levels of 60 pariticpants will be analyzed between baseline and week 12.
Baseline up to 12 weeks
Biochemical analysis
Time Frame: Baseline up to 12 weeks
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
Hormone analysis
Time Frame: Baseline up to 12 weeks
Changes in GLP-1 levels of 60 pariticpants will be analyzed between baseline and week 12.
Baseline up to 12 weeks
Hormone analysis
Time Frame: Baseline up to 12 weeks
Changes in DPP4 levels of 60 pariticpants will be analyzed between baseline and week 12.
Baseline up to 12 weeks
Hormone analysis
Time Frame: Baseline up to 12 weeks
Changes in adiponectin levels of 60 pariticpants will be analyzed between baseline and week 12.
Baseline up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Greenyn Biotechnology Co., Ltd.

Collaborators

Taipei Medical University

Investigators

  • Principal Investigator: Ming-Shun Wu, MD, Wanfang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

October 31, 2024

Study Registration Dates

First Submitted

February 1, 2023

First Submitted That Met QC Criteria

February 12, 2023

First Posted (Actual)

February 22, 2023

Study Record Updates

Last Update Posted (Actual)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-111-110

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ecuador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe