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

Primary Purpose

Diabetes, Metabolic Disease

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Pumpkin seed extract (Low dose)
Pumpkin seed extract (High dose)
Placebo
Sponsored by
Greenyn Biotechnology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • WanFang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo group

Low dose

High dose

Arm Description

Placebo capsule, one capsule/day (300 mg/day) for 3 months

Pumpkin seed extract capsule, one capsule/day (300 mg/day) for 3 months

Pumpkin seed extract capsule, two capsules/day (600 mg/day) for 3 months

Outcomes

Primary Outcome Measures

Biochemical analysis
Changes in fasting blodd sugar levels of 60 pariticpants will be analyzed between baseline and week 12.
Biochemical analysis
Changes in glycosylated hemoglobin levels of 60 pariticpants will be analyzed between baseline and week 12.
Biochemical analysis
Changes in insulin levels of 60 pariticpants will be analyzed between baseline and week 12.
Biochemical analysis
Changes in incremental area under the curve for glucose for 60 pariticpants will be analyzed between baseline and week 12.
Hormone analysis
Changes in GLP-1 levels of 60 pariticpants will be analyzed between baseline and week 12.
Hormone analysis
Changes in DPP4 levels of 60 pariticpants will be analyzed between baseline and week 12.
Hormone analysis
Changes in adiponectin levels of 60 pariticpants will be analyzed between baseline and week 12.

Secondary Outcome Measures

Full Information

First Posted
February 1, 2023
Last Updated
June 29, 2023
Sponsor
Greenyn Biotechnology Co., Ltd.
Collaborators
Taipei Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05738655
Brief Title
Effectiveness of Pumpkin Seed Extract on Improving Blood Sugar Level in Subhealth Subjects
Official Title
Effectiveness of Pumpkin Seed Extract on Improving Blood Sugar Level in Subhealth Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Greenyn Biotechnology Co., Ltd.
Collaborators
Taipei Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Metabolic Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Placebo capsule, one capsule/day (300 mg/day) for 3 months
Arm Title
Low dose
Arm Type
Experimental
Arm Description
Pumpkin seed extract capsule, one capsule/day (300 mg/day) for 3 months
Arm Title
High dose
Arm Type
Experimental
Arm Description
Pumpkin seed extract capsule, two capsules/day (600 mg/day) for 3 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Pumpkin seed extract (Low dose)
Intervention Description
Pumpkin seed extract standardized with specific peptides (300 mg/day)
Intervention Type
Dietary Supplement
Intervention Name(s)
Pumpkin seed extract (High dose)
Intervention Description
Pumpkin seed extract standardized with specific peptides (600 mg/day)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placeo (300 mg/day)
Primary Outcome Measure Information:
Title
Biochemical analysis
Description
Changes in fasting blodd sugar levels of 60 pariticpants will be analyzed between baseline and week 12.
Time Frame
Baseline up to 12 weeks
Title
Biochemical analysis
Description
Changes in glycosylated hemoglobin levels of 60 pariticpants will be analyzed between baseline and week 12.
Time Frame
Baseline up to 12 weeks
Title
Biochemical analysis
Description
Changes in insulin levels of 60 pariticpants will be analyzed between baseline and week 12.
Time Frame
Baseline up to 12 weeks
Title
Biochemical analysis
Description
Changes in incremental area under the curve for glucose for 60 pariticpants will be analyzed between baseline and week 12.
Time Frame
Baseline up to 12 weeks
Title
Hormone analysis
Description
Changes in GLP-1 levels of 60 pariticpants will be analyzed between baseline and week 12.
Time Frame
Baseline up to 12 weeks
Title
Hormone analysis
Description
Changes in DPP4 levels of 60 pariticpants will be analyzed between baseline and week 12.
Time Frame
Baseline up to 12 weeks
Title
Hormone analysis
Description
Changes in adiponectin levels of 60 pariticpants will be analyzed between baseline and week 12.
Time Frame
Baseline up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ming-Shun Wu, MD
Phone
+886-229307930
Email
mswu@tmu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming-Shun Wu, MD
Organizational Affiliation
WanFang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
WanFang Hospital
City
Taipei
ZIP/Postal Code
116
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming-Shun Wu, MD
Phone
+886-229307930
Email
mswu@tmu.edu.tw
First Name & Middle Initial & Last Name & Degree
Ming-Shun Wu, MD

12. IPD Sharing Statement

Learn more about this trial

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

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