Effectiveness of IRK-19® on Body Weight Control

Metabolic Syndrome Clinical Trial

Official title:

Effectiveness of IRK-19® on Body Weight Control

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05542160
• Other study ID #: G-CAZ0040161110628-1
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: February 2024
• Source: Greenyn Biotechnology Co., Ltd.
• Contact: Yen-Nung Lin, MD
• Phone: 886-229307930
• Email: solin[@]w.tmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 30, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Metabolic Syndrome
• Overweight

Intervention

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

Locations

Country	Name	City	State
Taiwan	WanFang Hospital	Taipei City

Sponsors (2)

Lead Sponsor	Collaborator
Greenyn Biotechnology Co., Ltd.	Taipei Medical University WanFang Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anthropometric measurement	Body weight	Week 0
Primary	Anthropometric measurement	Body weight	Week 6
Primary	Anthropometric measurement	Body weight	Week 12
Primary	Anthropometric measurement	Waist circumference	Week 0
Primary	Anthropometric measurement	Waist circumference	Week 6
Primary	Anthropometric measurement	Waist circumference	Week 12
Primary	Anthropometric measurement	Hip circumference	Week 0
Primary	Anthropometric measurement	Hip circumference	Week 6
Primary	Anthropometric measurement	Hip circumference	Week 12
Primary	Body composition analysis	Body fat	Week 0
Primary	Body composition analysis	Body fat	Week 6
Primary	Body composition analysis	Body fat	Week 12
Primary	Body composition analysis	Visceral fat	Week 0
Primary	Body composition analysis	Visceral fat	Week 6
Primary	Body composition analysis	Visceral fat	Week 12
Primary	Body composition analysis	Subcutaneous fat	Week 0
Primary	Body composition analysis	Subcutaneous fat	Week 6
Primary	Body composition analysis	Subcutaneous fat	Week 12
Primary	Biochemistry	Total cholesterol	Week 0
Primary	Biochemistry	Total cholesterol	Week 6
Primary	Biochemistry	Total cholesterol	Week 12
Primary	Biochemistry	Triacylglycerol	Week 0
Primary	Biochemistry	Triacylglycerol	Week 6
Primary	Biochemistry	Triacylglycerol	Week 12
Primary	Biochemistry	HDL	Week 0
Primary	Biochemistry	HDL	Week 6
Primary	Biochemistry	HDL	Week 12
Primary	Biochemistry	LDL	Week 0
Primary	Biochemistry	LDL	Week 6
Primary	Biochemistry	LDL	Week 12
Primary	Biochemistry	Adiponectin	Week 0
Primary	Biochemistry	Adiponectin	Week 6
Primary	Biochemistry	Adiponectin	Week 12
Primary	Biochemistry	Lectin	Week 0
Primary	Biochemistry	Lectin	Week 6
Primary	Biochemistry	Lectin	Weeks 12
Primary	Biochemistry	Fasting blood glucose	Week 0
Primary	Biochemistry	Fasting blood glucose	Week 6
Primary	Biochemistry	Fasting blood glucose	Week 12
Primary	Biochemistry	Insulin	Week 0
Primary	Biochemistry	Insulin	Week 6
Primary	Biochemistry	Insulin	Week 12