Back to resultsEffectiveness of IRK-19® on Body Weight Control
Primary Purpose
Overweight, Metabolic Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Pumpkin seed extract (IRK-19)
Sponsored by
About this trial
This is an interventional prevention trial for Overweight
Eligibility Criteria
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.
Sites / Locations
- WanFang HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Treatment
Arm Description
Placebo capsule
IRK-19 capsule
Outcomes
Primary Outcome Measures
Anthropometric measurement
Body weight
Anthropometric measurement
Body weight
Anthropometric measurement
Body weight
Anthropometric measurement
Waist circumference
Anthropometric measurement
Waist circumference
Anthropometric measurement
Waist circumference
Anthropometric measurement
Hip circumference
Anthropometric measurement
Hip circumference
Anthropometric measurement
Hip circumference
Body composition analysis
Body fat
Body composition analysis
Body fat
Body composition analysis
Body fat
Body composition analysis
Visceral fat
Body composition analysis
Visceral fat
Body composition analysis
Visceral fat
Body composition analysis
Subcutaneous fat
Body composition analysis
Subcutaneous fat
Body composition analysis
Subcutaneous fat
Biochemistry
Total cholesterol
Biochemistry
Total cholesterol
Biochemistry
Total cholesterol
Biochemistry
Triacylglycerol
Biochemistry
Triacylglycerol
Biochemistry
Triacylglycerol
Biochemistry
HDL
Biochemistry
HDL
Biochemistry
HDL
Biochemistry
LDL
Biochemistry
LDL
Biochemistry
LDL
Biochemistry
Adiponectin
Biochemistry
Adiponectin
Biochemistry
Adiponectin
Biochemistry
Lectin
Biochemistry
Lectin
Biochemistry
Lectin
Biochemistry
Fasting blood glucose
Biochemistry
Fasting blood glucose
Biochemistry
Fasting blood glucose
Biochemistry
Insulin
Biochemistry
Insulin
Biochemistry
Insulin
Secondary Outcome Measures
Full Information
NCT ID
NCT05542160
First Posted
September 13, 2022
Last Updated
February 1, 2023
Sponsor
Greenyn Biotechnology Co., Ltd.
Collaborators
Taipei Medical University WanFang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05542160
Brief Title
Effectiveness of IRK-19® on Body Weight Control
Official Title
Effectiveness of IRK-19® on Body Weight Control
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Greenyn Biotechnology Co., Ltd.
Collaborators
Taipei Medical University WanFang Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Metabolic Syndrome
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsule
Arm Title
Treatment
Arm Type
Experimental
Arm Description
IRK-19 capsule
Intervention Type
Dietary Supplement
Intervention Name(s)
Pumpkin seed extract (IRK-19)
Intervention Description
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
Primary Outcome Measure Information:
Title
Anthropometric measurement
Description
Body weight
Time Frame
Week 0
Title
Anthropometric measurement
Description
Body weight
Time Frame
Week 6
Title
Anthropometric measurement
Description
Body weight
Time Frame
Week 12
Title
Anthropometric measurement
Description
Waist circumference
Time Frame
Week 0
Title
Anthropometric measurement
Description
Waist circumference
Time Frame
Week 6
Title
Anthropometric measurement
Description
Waist circumference
Time Frame
Week 12
Title
Anthropometric measurement
Description
Hip circumference
Time Frame
Week 0
Title
Anthropometric measurement
Description
Hip circumference
Time Frame
Week 6
Title
Anthropometric measurement
Description
Hip circumference
Time Frame
Week 12
Title
Body composition analysis
Description
Body fat
Time Frame
Week 0
Title
Body composition analysis
Description
Body fat
Time Frame
Week 6
Title
Body composition analysis
Description
Body fat
Time Frame
Week 12
Title
Body composition analysis
Description
Visceral fat
Time Frame
Week 0
Title
Body composition analysis
Description
Visceral fat
Time Frame
Week 6
Title
Body composition analysis
Description
Visceral fat
Time Frame
Week 12
Title
Body composition analysis
Description
Subcutaneous fat
Time Frame
Week 0
Title
Body composition analysis
Description
Subcutaneous fat
Time Frame
Week 6
Title
Body composition analysis
Description
Subcutaneous fat
Time Frame
Week 12
Title
Biochemistry
Description
Total cholesterol
Time Frame
Week 0
Title
Biochemistry
Description
Total cholesterol
Time Frame
Week 6
Title
Biochemistry
Description
Total cholesterol
Time Frame
Week 12
Title
Biochemistry
Description
Triacylglycerol
Time Frame
Week 0
Title
Biochemistry
Description
Triacylglycerol
Time Frame
Week 6
Title
Biochemistry
Description
Triacylglycerol
Time Frame
Week 12
Title
Biochemistry
Description
HDL
Time Frame
Week 0
Title
Biochemistry
Description
HDL
Time Frame
Week 6
Title
Biochemistry
Description
HDL
Time Frame
Week 12
Title
Biochemistry
Description
LDL
Time Frame
Week 0
Title
Biochemistry
Description
LDL
Time Frame
Week 6
Title
Biochemistry
Description
LDL
Time Frame
Week 12
Title
Biochemistry
Description
Adiponectin
Time Frame
Week 0
Title
Biochemistry
Description
Adiponectin
Time Frame
Week 6
Title
Biochemistry
Description
Adiponectin
Time Frame
Week 12
Title
Biochemistry
Description
Lectin
Time Frame
Week 0
Title
Biochemistry
Description
Lectin
Time Frame
Week 6
Title
Biochemistry
Description
Lectin
Time Frame
Weeks 12
Title
Biochemistry
Description
Fasting blood glucose
Time Frame
Week 0
Title
Biochemistry
Description
Fasting blood glucose
Time Frame
Week 6
Title
Biochemistry
Description
Fasting blood glucose
Time Frame
Week 12
Title
Biochemistry
Description
Insulin
Time Frame
Week 0
Title
Biochemistry
Description
Insulin
Time Frame
Week 6
Title
Biochemistry
Description
Insulin
Time Frame
Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yen-Nung Lin, MD
Phone
886-229307930
Ext
1600
Email
solin@w.tmu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yen-Nung Lin, MD
Organizational Affiliation
WanFang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
WanFang Hospital
City
Taipei City
ZIP/Postal Code
116
Country
Taiwan
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
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Effectiveness of IRK-19® on Body Weight Control
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