Tokyo, Aug. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000055250) titled 'Study to Evaluate the Effects of Test Food Consumption on Improving Exercise Performance and Reducing Fatigue in Japanese Women' on Aug. 16.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - CPCC Company Limited
Condition:
Condition - Female adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To confirm the effects of test food consumption on improving exercise performance and reducing post-exercise fatigue.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Consumption of the test food (4 tablet a day) for 9 weeks
Interventions/Control_2 - Consumption of the placebo food (4 tablet a day) for 9 weeks
Eligibility:
Age-lower limit - 20
years-old
Gender - Female
Key inclusion criteria - 1. Women aged 20 to below 50 years at the time of consent acquisition.
2. Subjects who engage in exercise habits once or twice a week (for at least 20 minutes per session).
*Exercise is defined as activities corresponding to 3.5 METs or more according to the revised "METs Table for Physical Activities" published by the National Institute of Health and Nutrition (NIHN), excluding resistance (weight) training.
3. Subjects who can maintain their exercise habits from before the study throughout the trial period.
4. Subjects who have not consumed prohibited foods or medications (listed in 'Other') within one week prior to obtaining consent and can refrain from consuming them during the trial period.
5. Subjects who can give informed consent to partake in this study, after being provided with an explanation of the protocol detail.
Key exclusion criteria - 1. Smokers (excluding those who have been non-smokers for more than one year).
2. Subjects who have bowel movements less than twice a week or have weak gastrointestinal health or are prone to diarrhea, as determined by background checks during the preliminary examination.
3. Subjects with excessive alcohol intake.
4. Subjects with extremely irregular eating habits or those with irregular life rhythms, such as shift workers or night shift workers.
5. Subjects who are participating in the other clinical trials and/or who have participated in the other clinical trials within 4 weeks prior to the current trial and/or who are planning to participate in the other clinical trials.
6. Subjects who donated blood or component (200 mL) within the last 1 months.
7. Subjects who donated her blood (400 mL) within the last 4 months.
8. Subjects who being collected in total of her blood (800 mL) within the last 12 months and in this study.
9. Subjects with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs.
10. Subjects with allergies to medications and/or food.
11. Subjects who are pregnant or lactating, and females who could become pregnant during trial period.
12. Subjects deemed unsuitable for participation in the trial by the principal investigator or sub-investigator.
Target Size - 30
Recruitment Status:
Recruitment status - No longer recruiting
Date of protocol fixation - 2024 Year 07 Month 31 Day
Date of IRB - 2024 Year 07 Month 26 Day
Anticipated trial start date - 2024 Year 08 Month 19 Day
Last follow-up date - 2025 Year 01 Month 20 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062790
Disclaimer: Curated by HT Syndication.
