NCT05738655

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable diabetes

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 22, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2024

Completed
Last Updated

February 23, 2024

Status Verified

February 1, 2024

Enrollment Period

1.6 years

First QC Date

February 1, 2023

Last Update Submit

February 21, 2024

Conditions

DiabetesMetabolic Disease

Outcome Measures

Primary Outcomes (7)

  • Biochemical analysis

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

    Baseline up to 12 weeks

  • Biochemical analysis

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

    Baseline up to 12 weeks

  • Biochemical analysis

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

    Baseline up to 12 weeks

  • 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

  • Hormone analysis

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

    Baseline up to 12 weeks

  • Hormone analysis

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

    Baseline up to 12 weeks

  • Hormone analysis

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

    Baseline up to 12 weeks

Study Arms (3)

Placebo group

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Low dose

EXPERIMENTAL

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

Dietary Supplement: Pumpkin seed extract (Low dose)

High dose

EXPERIMENTAL

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

Dietary Supplement: Pumpkin seed extract (High dose)

Interventions

Pumpkin seed extract (Low dose)DIETARY_SUPPLEMENT

Pumpkin seed extract standardized with specific peptides (300 mg/day)

Low dose
Pumpkin seed extract (High dose)DIETARY_SUPPLEMENT

Pumpkin seed extract standardized with specific peptides (600 mg/day)

High dose
PlaceboDIETARY_SUPPLEMENT

Placeo (300 mg/day)

Placebo group

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fasting blood sugar levels from 100 to 125 mg/dL
  • Glycated hemoglobin levels from 5.7 to 6.4%
  • hour OGTT levels from 140 to 199 mg/dL

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

WanFang Hospital

Taipei, 116, Taiwan

RECRUITING

MeSH Terms

Conditions

Diabetes MellitusMetabolic Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Ming-Shun Wu, MD

    WanFang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming-Shun Wu, MD

CONTACT

+886-229307930mswu@tmu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2023

First Posted

February 22, 2023

Study Start

March 1, 2023

Primary Completion

September 30, 2024

Study Completion

October 31, 2024

Last Updated

February 23, 2024

Record last verified: 2024-02

Locations

TW(1)