Tokyo, July 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058404) titled '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' on July 9.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - IMEQRD Co., Ltd.
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate the effects of 12 weeks of continuous consumption of a test supplement on body composition in men and women aged 20 to under 60 years with a BMI between 25.0 kg/m^2 and 30.0 kg/m^2.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Placebo group: 10 capsules taken once daily with water or lukewarm water after breakfast.
Interventions/Control_2 - Test supplement group: 10 capsules taken once daily with water or lukewarm water after breakfast.
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key 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.
Key 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.
Target Size - 80
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 06 Month 17 Day
Date of IRB - 2025 Year 06 Month 24 Day
Anticipated trial start date - 2025 Year 09 Month 11 Day
Last follow-up date - 2025 Year 12 Month 09 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066641
Disclaimer: Curated by HT Syndication.
