Effectiveness of IRK-19® on Body Weight Control

NCT ID: NCT05542160

Last Updated: 2024-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2024-06-30

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.

Detailed Description

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Conditions

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Overweight Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Placebo capsule

Group Type PLACEBO_COMPARATOR

Pumpkin seed extract (IRK-19)

Intervention Type 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

Treatment

IRK-19 capsule

Group Type EXPERIMENTAL

Pumpkin seed extract (IRK-19)

Intervention Type 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

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Taipei Medical University WanFang Hospital

OTHER

Sponsor Role collaborator

Greenyn Biotechnology Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yen-Nung Lin, MD

Role: PRINCIPAL_INVESTIGATOR

WanFang Hospital

Locations

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WanFang Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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G-CAZ0040161110628-1

Identifier Type: -

Identifier Source: org_study_id

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