Effectiveness of IRK-19® on Body Weight Control

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of IRK-19® on Body Weight Control

Conditions
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Overweight, Metabolic Syndrome

Intervention / Treatment
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* Dietary Supplement: Pumpkin seed extract (IRK-19)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI: 25-30 kg/m2 Waistline circumference: ˃ 80 cm Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo capsule | Dietary Supplement: Pumpkin seed extract (IRK-19)<br>* 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<br>|
| Experimental: Treatment<br>IRK-19 capsule | Dietary Supplement: Pumpkin seed extract (IRK-19)<br>* 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<br>|

What is the study measuring?
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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 |