OverweightNCT05542160
Effectiveness of IRK-19® on Body Weight Control
A study testing Pumpkin seed extract (IRK-19) in people with Overweight and Metabolic Syndrome, run by Greenyn Biotechnology Co., Ltd. at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Metabolic Syndrome
- What is being tested?
- Pumpkin seed extract (IRK-19)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2022to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI: 25-30 kg/m2
- Waistline circumference: ˃ 80 cm
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Overweight, Metabolic Syndrome
- Being tested
- Pumpkin seed extract (IRK-19)
- Medical subject headings
- Overweight, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pumpkin seed extract (IRK-19)Dietary supplement
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
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo capsule Receives: Dietary Supplement: Pumpkin seed extract (IRK-19) |
| Treatment | Experimental | IRK-19 capsule Receives: Dietary Supplement: Pumpkin seed extract (IRK-19) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anthropometric measurement
Body weight
Measured: Week 0
Anthropometric measurement
Body weight
Measured: Week 6
Anthropometric measurement
Body weight
Measured: Week 12
Anthropometric measurement
Waist circumference
Measured: Week 0
Anthropometric measurement
Waist circumference
Measured: Week 6
Anthropometric measurement
Waist circumference
Measured: Week 12
Anthropometric measurement
Hip circumference
Measured: Week 0
Anthropometric measurement
Hip circumference
Measured: Week 6
Anthropometric measurement
Hip circumference
Measured: Week 12
Body composition analysis
Body fat
Measured: Week 0
Body composition analysis
Body fat
Measured: Week 6
Body composition analysis
Body fat
Measured: Week 12
Body composition analysis
Visceral fat
Measured: Week 0
Body composition analysis
Visceral fat
Measured: Week 6
Body composition analysis
Visceral fat
Measured: Week 12
Body composition analysis
Subcutaneous fat
Measured: Week 0
Body composition analysis
Subcutaneous fat
Measured: Week 6
Body composition analysis
Subcutaneous fat
Measured: Week 12
Biochemistry
Total cholesterol
Measured: Week 0
Biochemistry
Total cholesterol
Measured: Week 6
Biochemistry
Total cholesterol
Measured: Week 12
Biochemistry
Triacylglycerol
Measured: Week 0
Biochemistry
Triacylglycerol
Measured: Week 6
Biochemistry
Triacylglycerol
Measured: Week 12
Biochemistry
HDL
Measured: Week 0
Biochemistry
HDL
Measured: Week 6
Biochemistry
HDL
Measured: Week 12
Biochemistry
LDL
Measured: Week 0
Biochemistry
LDL
Measured: Week 6
Biochemistry
LDL
Measured: Week 12
Biochemistry
Adiponectin
Measured: Week 0
Biochemistry
Adiponectin
Measured: Week 6
Biochemistry
Adiponectin
Measured: Week 12
Biochemistry
Lectin
Measured: Week 0
Biochemistry
Lectin
Measured: Week 6
Biochemistry
Lectin
Measured: Weeks 12
Biochemistry
Fasting blood glucose
Measured: Week 0
Biochemistry
Fasting blood glucose
Measured: Week 6
Biochemistry
Fasting blood glucose
Measured: Week 12
Biochemistry
Insulin
Measured: Week 0
Biochemistry
Insulin
Measured: Week 6
Biochemistry
Insulin
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start1 Oct 2022
- Primary completion29 Feb 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Greenyn Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Taipei Medical University WanFang Hospital
- Responsible party
- Sponsor
- Investigators
- Yen-Nung Lin, MD, Principal investigator, WanFang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05542160
- Sponsor's protocol ID
- G-CAZ0040161110628-1
- Status last verified
- Aug 2024
- First submitted
- 13 Sep 2022
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of IRK-19® on Body Weight Control
- ClinicalTrials.gov ID
- NCT05542160
- Acronym / sponsor ID
- G-CAZ0040161110628-1
- Conditions
- Overweight, Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Greenyn Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Taipei Medical University WanFang Hospital
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 15 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Pumpkin seed extract (IRK-19)Placebo capsule |
| Treatment | Experimental | Dietary Supplement: Pumpkin seed extract (IRK-19)IRK-19 capsule |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI: 25-30 kg/m2
- Waistline circumference: ˃ 80 cm
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Dietary supplement | Placebo, Treatment |
Primary outcome
Anthropometric measurement
Time frame: Week 0
Body weight
Anthropometric measurement
Time frame: Week 6
Body weight
Anthropometric measurement
Time frame: Week 12
Body weight
Anthropometric measurement
Time frame: Week 0
Waist circumference
Anthropometric measurement
Time frame: Week 6
Waist circumference
Anthropometric measurement
Time frame: Week 12
Waist circumference
Anthropometric measurement
Time frame: Week 0
Hip circumference
Anthropometric measurement
Time frame: Week 6
Hip circumference
Anthropometric measurement
Time frame: Week 12
Hip circumference
Body composition analysis
Time frame: Week 0
Body fat
Body composition analysis
Time frame: Week 6
Body fat
Body composition analysis
Time frame: Week 12
Body fat
Body composition analysis
Time frame: Week 0
Visceral fat
Body composition analysis
Time frame: Week 6
Visceral fat
Body composition analysis
Time frame: Week 12
Visceral fat
Body composition analysis
Time frame: Week 0
Subcutaneous fat
Body composition analysis
Time frame: Week 6
Subcutaneous fat
Body composition analysis
Time frame: Week 12
Subcutaneous fat
Biochemistry
Time frame: Week 0
Total cholesterol
Biochemistry
Time frame: Week 6
Total cholesterol
Biochemistry
Time frame: Week 12
Total cholesterol
Biochemistry
Time frame: Week 0
Triacylglycerol
Biochemistry
Time frame: Week 6
Triacylglycerol
Biochemistry
Time frame: Week 12
Triacylglycerol
Biochemistry
Time frame: Week 0
HDL
Biochemistry
Time frame: Week 6
HDL
Biochemistry
Time frame: Week 12
HDL
Biochemistry
Time frame: Week 0
LDL
Biochemistry
Time frame: Week 6
LDL
Biochemistry
Time frame: Week 12
LDL
Biochemistry
Time frame: Week 0
Adiponectin
Biochemistry
Time frame: Week 6
Adiponectin
Biochemistry
Time frame: Week 12
Adiponectin
Biochemistry
Time frame: Week 0
Lectin
Biochemistry
Time frame: Week 6
Lectin
Biochemistry
Time frame: Weeks 12
Lectin
Biochemistry
Time frame: Week 0
Fasting blood glucose
Biochemistry
Time frame: Week 6
Fasting blood glucose
Biochemistry
Time frame: Week 12
Fasting blood glucose
Biochemistry
Time frame: Week 0
Insulin
Biochemistry
Time frame: Week 6
Insulin
Biochemistry
Time frame: Week 12
Insulin
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Overweight
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yen-Nung Lin, MD principal investigator
WanFang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pumpkin seed extract (IRK-19) in people with Overweight and Metabolic Syndrome, run by Greenyn Biotechnology Co., Ltd. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anthropometric measurement (time frame: Week 0). The study lists 42 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.