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Completed

NCT Number: NCT05542160

Effectiveness of IRK-19® on Body Weight Control

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.

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Key information

Conditions

Overweight Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

WanFang Hospital

Taipei, 116, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Anthropometric measurement

    Time frame: Week 0

    Body weight

  2. Anthropometric measurement

    Time frame: Week 6

    Body weight

  3. Anthropometric measurement

    Time frame: Week 12

    Body weight

  4. Anthropometric measurement

    Time frame: Week 0

    Waist circumference

  5. Anthropometric measurement

    Time frame: Week 6

    Waist circumference

  6. Anthropometric measurement

    Time frame: Week 12

    Waist circumference

  7. Anthropometric measurement

    Time frame: Week 0

    Hip circumference

  8. Anthropometric measurement

    Time frame: Week 6

    Hip circumference

  9. Anthropometric measurement

    Time frame: Week 12

    Hip circumference

  10. Body composition analysis

    Time frame: Week 0

    Body fat

  11. Body composition analysis

    Time frame: Week 6

    Body fat

  12. Body composition analysis

    Time frame: Week 12

    Body fat

  13. Body composition analysis

    Time frame: Week 0

    Visceral fat

  14. Body composition analysis

    Time frame: Week 6

    Visceral fat

  15. Body composition analysis

    Time frame: Week 12

    Visceral fat

  16. Body composition analysis

    Time frame: Week 0

    Subcutaneous fat

  17. Body composition analysis

    Time frame: Week 6

    Subcutaneous fat

  18. Body composition analysis

    Time frame: Week 12

    Subcutaneous fat

  19. Biochemistry

    Time frame: Week 0

    Total cholesterol

  20. Biochemistry

    Time frame: Week 6

    Total cholesterol

  21. Biochemistry

    Time frame: Week 12

    Total cholesterol

  22. Biochemistry

    Time frame: Week 0

    Triacylglycerol

  23. Biochemistry

    Time frame: Week 6

    Triacylglycerol

  24. Biochemistry

    Time frame: Week 12

    Triacylglycerol

  25. Biochemistry

    Time frame: Week 0

    HDL

  26. Biochemistry

    Time frame: Week 6

    HDL

  27. Biochemistry

    Time frame: Week 12

    HDL

  28. Biochemistry

    Time frame: Week 0

    LDL

  29. Biochemistry

    Time frame: Week 6

    LDL

  30. Biochemistry

    Time frame: Week 12

    LDL

  31. Biochemistry

    Time frame: Week 0

    Adiponectin

  32. Biochemistry

    Time frame: Week 6

    Adiponectin

  33. Biochemistry

    Time frame: Week 12

    Adiponectin

  34. Biochemistry

    Time frame: Week 0

    Lectin

  35. Biochemistry

    Time frame: Week 6

    Lectin

  36. Biochemistry

    Time frame: Weeks 12

    Lectin

  37. Biochemistry

    Time frame: Week 0

    Fasting blood glucose

  38. Biochemistry

    Time frame: Week 6

    Fasting blood glucose

  39. Biochemistry

    Time frame: Week 12

    Fasting blood glucose

  40. Biochemistry

    Time frame: Week 0

    Insulin

  41. Biochemistry

    Time frame: Week 6

    Insulin

  42. Biochemistry

    Time frame: Week 12

    Insulin

Sponsors and collaborators

Lead sponsor

Greenyn Biotechnology Co., Ltd.

Industry

Collaborators

  • Taipei Medical University WanFang Hospital

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 15, 2022
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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