Effectiveness of IRK-19® on Body Weight Control

Not Applicable

Completed

• Conditions: Overweight; Metabolic Syndrome
• Interventions: Dietary Supplement: Pumpkin seed extract (IRK-19)

• Registration Number: NCT05542160
• Lead Sponsor: Greenyn Biotechnology Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-13
• Study First Submitted QC: 2022-09-13
• Study First Posted: 2022-09-15
• Study Start: 2022-10-01
• Primary Completion: 2024-02-29
• Study Completion: 2024-06-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-07
• Last Update Posted: 2024-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Pumpkin seed extract (IRK-19)	Placebo capsule
Treatment	Pumpkin seed extract (IRK-19)	IRK-19 capsule

Primary Outcome Measures

Name	Time	Method
Biochemistry	Week 12	Insulin
Anthropometric measurement	Week 12	Hip circumference
Body composition analysis	Week 12	Subcutaneous fat

Trial Locations

Locations (1)

WanFang Hospital; 🇨🇳 Taipei City, Taiwan