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

• Sponsor: Greenyn Biotechnology Co., Ltd. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05738655
• Collaborator: Taipei Medical University (Other)
• Enrollment: 60
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 10
• Patients Per Site Per Month: 6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes; Metabolic Disease	Dietary Supplement: Pumpkin seed extract (Low dose); Dietary Supplement: Pumpkin seed extract (High dose); Dietary Supplement: Placebo	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Parallel AssignmentParallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Effectiveness of Pumpkin Seed Extract on Improving Blood Sugar Level in Subhealth Subjects
• Anticipated Study Start Date: Mar 1, 2023
• Anticipated Primary Completion Date: Nov 30, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Biochemical analysis [Baseline up to 12 weeks]

   Changes in fasting blodd sugar levels of 60 pariticpants will be analyzed between baseline and week 12.

2. Biochemical analysis [Baseline up to 12 weeks]

   Changes in glycosylated hemoglobin levels of 60 pariticpants will be analyzed between baseline and week 12.

3. Biochemical analysis [Baseline up to 12 weeks]

   Changes in insulin levels of 60 pariticpants will be analyzed between baseline and week 12.

4. Biochemical analysis [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.

5. Hormone analysis [Baseline up to 12 weeks]

   Changes in GLP-1 levels of 60 pariticpants will be analyzed between baseline and week 12.

6. Hormone analysis [Baseline up to 12 weeks]

   Changes in DPP4 levels of 60 pariticpants will be analyzed between baseline and week 12.

7. Hormone analysis [Baseline up to 12 weeks]

   Changes in adiponectin levels of 60 pariticpants will be analyzed between baseline and week 12.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	WanFang Hospital	Taipei		Taiwan	116

Sponsors and Collaborators

• Greenyn Biotechnology Co., Ltd.
• Taipei Medical University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Greenyn Biotechnology Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05738655
• Other Study ID Numbers: A-111-110
• First Posted: Feb 22, 2023
• Last Update Posted: Feb 22, 2023
• Last Verified: Feb 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Metabolic Diseases

Study Results

No Results Posted as of Feb 22, 2023