Clinical trial NCT05542160: Effectiveness of IRK-19® on Body Weight Control
Official title: Effectiveness of IRK-19® on Body Weight Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Metabolic Syndrome
Lead sponsor: Greenyn Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Taipei Medical University WanFang Hospital
First posted: 2022-09-15
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Anthropometric measurement
timeFrame: Week 0
measure: Anthropometric measurement
timeFrame: Week 6
measure: Anthropometric measurement
timeFrame: Week 12
measure: Anthropometric measurement
timeFrame: Week 0
measure: Anthropometric measurement
timeFrame: Week 6
measure: Anthropometric measurement
timeFrame: Week 12
measure: Anthropometric measurement
timeFrame: Week 0
measure: Anthropometric measurement
timeFrame: Week 6
measure: Anthropometric measurement
timeFrame: Week 12
measure: Body composition analysis
timeFrame: Week 0
measure: Body composition analysis
timeFrame: Week 6
measure: Body composition analysis
timeFrame: Week 12
measure: Body composition analysis
timeFrame: Week 0
measure: Body composition analysis
timeFrame: Week 6
measure: Body composition analysis
timeFrame: Week 12
measure: Body composition analysis
timeFrame: Week 0
measure: Body composition analysis
timeFrame: Week 6
measure: Body composition analysis
timeFrame: Week 12
measure: Biochemistry
timeFrame: Week 0
measure: Biochemistry
timeFrame: Week 6
measure: Biochemistry
timeFrame: Week 12
measure: Biochemistry
timeFrame: Week 0
measure: Biochemistry
timeFrame: Week 6
measure: Biochemistry
timeFrame: Week 12
measure: Biochemistry
timeFrame: Week 0
measure: Biochemistry
timeFrame: Week 6
measure: Biochemistry
timeFrame: Week 12
measure: Biochemistry
timeFrame: Week 0
measure: Biochemistry
timeFrame: Week 6
measure: Biochemistry
timeFrame: Week 12
measure: Biochemistry
timeFrame: Week 0
measure: Biochemistry
timeFrame: Week 6
measure: Biochemistry
timeFrame: Week 12
measure: Biochemistry
timeFrame: Week 0
measure: Biochemistry
timeFrame: Week 6
measure: Biochemistry
timeFrame: Weeks 12
measure: Biochemistry
timeFrame: Week 0
measure: Biochemistry
timeFrame: Week 6
measure: Biochemistry
timeFrame: Week 12
measure: Biochemistry
timeFrame: Week 0
measure: Biochemistry
timeFrame: Week 6
measure: Biochemistry
timeFrame: Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: WanFang Hospital
Study officials:
affiliation: WanFang Hospital
name: Yen-Nung Lin, MD
role: PRINCIPAL_INVESTIGATOR
References: