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A Study on the Effects of Continuous Consumption of a Test Supplement on Body Composition in Adults with Mild Obesity: A Randomized, Double-blind, Placebo-Controlled, Parallel-Group Comparison Trial

A Study on the Effects of Continuous Consumption of a Test Supplement on Body Composition in Adults with Mild Obesity: A Randomized, Double-blind, Placebo-Controlled, Parallel-Group Comparison Trial - A Study on the Effects of Continuous Consumption of a Test Supplement on Body Composition in Adults with Mild Obesity

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000058404
Enrollment
80
Registered
2025-07-09
Start date
2025-09-11
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy adults

Interventions

Placebo group: 10 capsules taken once daily with water or lukewarm water after breakfast. Test supplement group: 10 capsules taken once daily with water or lukewarm water after breakfast.

Sponsors

IMEQRD Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age: 20 to under 60 years. 2. Gender: Japanese men and women. 3. BMI: Between 25.0 kg/m^2 and 30.0 kg/m^2. 4. Ability to input electronic diaries via smartphone or PC. 5. Individuals who have received a sufficient explanation about the study's objectives and content, fully understand them, voluntarily wish to participate and provide written consent for participation.

Exclusion criteria

Exclusion criteria: 1. Currently undergoing treatment for any disease with medication or herbal remedies (occasional use permitted). 2. Individuals under dietary or exercise therapy supervised by a physician. 3. Individuals with a history or current presence of severe diseases. 4. Individuals with gastrointestinal disorders or a history of gastrointestinal surgery affecting digestion and absorption (appendicitis excluded). 5. Individuals who have undergone obesity surgery within the past year or are scheduled for such surgery. 6. Individuals consuming healthy foods or supplements that may affect obesity, blood sugar, or lipid metabolism (including foods with specific health claims or functional labeling; participation allowed if discontinued after consent). 7. History or presence of drug or food allergies. 8. Individuals with irregular lifestyles due to night shifts or rotating work schedules. 9. Individuals planning significant lifestyle changes (diet, sleep, exercise, etc.) during the study period. 10. Heavy alcohol consumers. 11. Individuals planning overseas travel during the study period. 12. Pregnant, breastfeeding, or planning to become pregnant during the study period. 13. Individuals who have undergone blood collection exceeding 200 mL within the past month or 400 mL within the past three months. 14. Individuals who participated in other clinical studies within the past month or are currently participating/planning to participate during the study period. 15. Individuals with implanted orthopedic metal devices. 16. Individuals considered unsuitable for participation by the principal investigator.

Design outcomes

Primary

MeasureTime frame
Change in body fat mass over 12 weeks, measured using the DXA method.

Secondary

MeasureTime frame
- Change in lean body mass (LBM) over 12 weeks. - Change in body weight and BMI over 12 weeks. - Change in waist circumference over 12 weeks. - Changes in fat mass, fat percentage, and lean body mass in specific regions (arms, legs, trunk, abdomen [Android], and hips [Gynoid]) over 12 weeks, measured using the DXA method. - Changes in blood markers (leptin, adiponectin, T-cho, HDL-C, LDL-C, TG) over 12 weeks.

Countries

Japan

Contacts

Public ContactYoshitada Hira

IMEQRD Co., Ltd. Planning and Sales Department

clinical-trial@imeqrd.co.jp0367045968

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026