Effectiveness of IRK-19® on Body Weight Control

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.

Study Overview

• Status: Recruiting
• Conditions: Overweight; Metabolic Syndrome
• Intervention / Treatment: Dietary supplement: Pumpkin seed extract (IRK-19)

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yen-Nung Lin, MD; Phone Number: 1600 886-229307930; Email: solin@w.tmu.edu.tw

Study Locations

• Taiwan
  • Taipei City, Taiwan, 116
    • Recruiting
    • WanFang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 58 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. BMI: 25-30 kg/m2
2. Waistline circumference: ˃ 80 cm

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo capsule	Dietary supplement: Pumpkin seed extract (IRK-19); 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
Experimental: Treatment; IRK-19 capsule	Dietary supplement: Pumpkin seed extract (IRK-19); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Greenyn Biotechnology Co., Ltd.
• Collaborators: Taipei Medical University WanFang Hospital
• Investigators: Principal Investigator: Yen-Nung Lin, MD, WanFang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Estimated): February 29, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: September 13, 2022
• First Submitted That Met QC Criteria: September 13, 2022
• First Posted (Actual): September 15, 2022

Study Record Updates

• Last Update Posted (Estimated): 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: Glucose Metabolism Disorders; Metabolic Diseases; Overnutrition; Nutrition Disorders; Insulin Resistance; Hyperinsulinism; Metabolic Syndrome; Overweight; Body Weight
• Other Study ID Numbers: G-CAZ0040161110628-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No