NCT05542160

Brief Summary

This randomized, double-blind, placebo-controlled, and parallel clinical study aims to investigate the effectivness of a pumpkin seed extract (IRK-19®) on weight management.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
completed

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

September 13, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2022

Completed
16 days until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

1.4 years

First QC Date

September 13, 2022

Last Update Submit

August 7, 2024

Conditions

OverweightMetabolic Syndrome

Outcome Measures

Primary Outcomes (42)

  • Anthropometric measurement

    Body weight

    Week 0

  • Anthropometric measurement

    Body weight

    Week 6

  • Anthropometric measurement

    Body weight

    Week 12

  • Anthropometric measurement

    Waist circumference

    Week 0

  • Anthropometric measurement

    Waist circumference

    Week 6

  • Anthropometric measurement

    Waist circumference

    Week 12

  • Anthropometric measurement

    Hip circumference

    Week 0

  • Anthropometric measurement

    Hip circumference

    Week 6

  • Anthropometric measurement

    Hip circumference

    Week 12

  • Body composition analysis

    Body fat

    Week 0

  • Body composition analysis

    Body fat

    Week 6

  • Body composition analysis

    Body fat

    Week 12

  • Body composition analysis

    Visceral fat

    Week 0

  • Body composition analysis

    Visceral fat

    Week 6

  • Body composition analysis

    Visceral fat

    Week 12

  • Body composition analysis

    Subcutaneous fat

    Week 0

  • Body composition analysis

    Subcutaneous fat

    Week 6

  • Body composition analysis

    Subcutaneous fat

    Week 12

  • Biochemistry

    Total cholesterol

    Week 0

  • Biochemistry

    Total cholesterol

    Week 6

  • Biochemistry

    Total cholesterol

    Week 12

  • Biochemistry

    Triacylglycerol

    Week 0

  • Biochemistry

    Triacylglycerol

    Week 6

  • Biochemistry

    Triacylglycerol

    Week 12

  • Biochemistry

    HDL

    Week 0

  • Biochemistry

    HDL

    Week 6

  • Biochemistry

    HDL

    Week 12

  • Biochemistry

    LDL

    Week 0

  • Biochemistry

    LDL

    Week 6

  • Biochemistry

    LDL

    Week 12

  • Biochemistry

    Adiponectin

    Week 0

  • Biochemistry

    Adiponectin

    Week 6

  • Biochemistry

    Adiponectin

    Week 12

  • Biochemistry

    Lectin

    Week 0

  • Biochemistry

    Lectin

    Week 6

  • Biochemistry

    Lectin

    Weeks 12

  • Biochemistry

    Fasting blood glucose

    Week 0

  • Biochemistry

    Fasting blood glucose

    Week 6

  • Biochemistry

    Fasting blood glucose

    Week 12

  • Biochemistry

    Insulin

    Week 0

  • Biochemistry

    Insulin

    Week 6

  • Biochemistry

    Insulin

    Week 12

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo capsule

Dietary Supplement: Pumpkin seed extract (IRK-19)

Treatment

EXPERIMENTAL

IRK-19 capsule

Dietary Supplement: Pumpkin seed extract (IRK-19)

Interventions

Pumpkin seed extract (IRK-19)DIETARY_SUPPLEMENT

Placebo: Dietary fiber powder, two capsules/day (600 mg/day), continued use for 3 months Treatment: Pumpkin seed extract powder, two capsules/day (600 mg/day), continued use for 3 months

PlaceboTreatment

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI: 25-30 kg/m2
  • Waistline circumference: ˃ 80 cm

You may not qualify if:

  • Pregnant women or preparing for pregnancy.
  • Lactating women.
  • Women gave birth 6 months before the study.
  • Subject uses diuretic, corticosteroids, anti-depressant medications, or antipsychotic medications.
  • Subject has undertaken obesity-related surgeries within one year prior to the study or other surgeries within six months prior to the study.
  • Change of body weight of subject is over 5% within 3 months before the study.
  • Subject has serious diseases (e.g., cardiovascular diseases).
  • Cancer patient.
  • Subject has engaged in another study within 3 months before the study.
  • Subject uses another dietary supplement related to weight management during the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

WanFang Hospital

Taipei, 116, Taiwan

Location

MeSH Terms

Conditions

OverweightMetabolic Syndrome

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Yen-Nung Lin, MD

    WanFang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 13, 2022

First Posted

September 15, 2022

Study Start

October 1, 2022

Primary Completion

February 29, 2024

Study Completion

June 30, 2024

Last Updated

August 9, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)